A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke "PRISMS"

Terminated

Phase 3 Results N/A

Update History

7 Jul '17
The Summary of Purpose was updated.
New
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).
Old
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).
The eligibility criteria were updated.
New
Inclusion Criteria: - Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to() one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory) 2. MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory), 3. Imaging lesion consistent with acute hemorrhage, or 4. Evidence of intraparenchymal tumor - Disability prior to the presenting stroke - Standard contraindications to IV alteplase within 3 hours of symptom onset, including: 1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months 2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days 3. Major surgery within the previous 14 days 4. Arterial puncture at non-compressible site within the previous 7 days 5. Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI 6. Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels 7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range 8. Blood glucose <50 milligrams per deciliter (mg/dL) 9. International normalized ratio >1.7 10. Platelet count <100,000 per cubic millimeter (/mm^3) 11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours - Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) - Females of childbearing age who are known to be pregnant and/or lactating - Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet - Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days - Current or recent (within 3 months) participation in another investigational drug treatment protocol - Anticipated inability to obtain 3-month follow-up assessments - Previous enrollment in PRISMS - Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment
Old
Inclusion Criteria: - Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to() one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory) 2. MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory), 3. Imaging lesion consistent with acute hemorrhage, or 4. Evidence of intraparenchymal tumor - Disability prior to the presenting stroke - Standard contraindications to IV alteplase within 3 hours of symptom onset, including: 1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months 2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days 3. Major surgery within the previous 14 days 4. Arterial puncture at non-compressible site within the previous 7 days 5. Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI 6. Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels 7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range 8. Blood glucose <50 milligrams per deciliter (mg/dL) 9. International normalized ratio >1.7 10. Platelet count <100,000 per cubic millimeter (/mm^3) 11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours - Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) - Females of childbearing age who are known to be pregnant and/or lactating - Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet - Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days - Current or recent (within 3 months) participation in another investigational drug treatment protocol - Anticipated inability to obtain 3-month follow-up assessments - Previous enrollment in PRISMS - Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment
12 May '17
Trial acronym was updated.
New
PRISMS
Trial name was updated.
New
A Study of the Efficacy and Safety of Alteplase in Participants With Mild Stroke
The Summary of Purpose was updated.
New
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) alteplase in participants with mild acute ischemic strokes that do not appear to be clearly disabling. Participants will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV alteplase and one dose of oral aspirin placebo or 2) one dose of IV alteplase placebo and one dose of oral aspirin 325 milligrams (mg).
Old
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV Activase placebo and one dose of oral aspirin 325 mg.
The gender criteria for eligibility was updated to "All."
The eligibility criteria were updated.
New
Inclusion Criteria: - Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of less than or equal to() one-third middle cerebral artery (MCA) territory (or >100 cubic centimeter [cc] if not in MCA territory) 2. MRI with clear large hyperintensity on concurrent diffusion-weighted (DW) and fluid-attenuated inversion recovery (FLAIR) that is greater than one-third MCA territory (or greater than 100 cc if not in MCA territory), 3. Imaging lesion consistent with acute hemorrhage, or 4. Evidence of intraparenchymal tumor - Disability prior to the presenting stroke - Standard contraindications to IV alteplase within 3 hours of symptom onset, including: 1. Head trauma, myocardial infarction, or previous stroke within the previous 3 months 2. Gastrointestinal or urinary tract hemorrhage within the previous 21 days 3. Major surgery within the previous 14 days 4. Arterial puncture at non-compressible site within the previous 7 days 5. Any history of ICH with the exception of those less than (<) 5 chronic microbleeds on MRI 6. Elevated blood pressure defined by systolic blood pressure >185 millimeters of mercury (mm Hg) or diastolic blood pressure >110 mm Hg, or treatments requiring aggressive measures to achieve acceptable levels 7. Treatment with unfractioned heparin within past 48 hours and activated partial thromboplastin time outside normal range 8. Blood glucose <50 milligrams per deciliter (mg/dL) 9. International normalized ratio >1.7 10. Platelet count <100,000 per cubic millimeter (/mm^3) 11. Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban, edoxaban) within the last 48 hours - Allergic reaction to study drug, aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) - Females of childbearing age who are known to be pregnant and/or lactating - Inability to swallow, which would prevent oral intake of aspirin or aspirin placebo tablet - Other serious, advanced, or terminal illness that would confound the clinical outcome at 90 days - Current or recent (within 3 months) participation in another investigational drug treatment protocol - Anticipated inability to obtain 3-month follow-up assessments - Previous enrollment in PRISMS - Any other condition deemed by the investigator that would pose hazard to the participant with alteplase treatment
Old
Inclusion Criteria: - Age >/= 18 years. - Mild ischemic stroke defined as the most recent pre-treatment NIHSS score of one-third middle cerebral artery (MCA) territory or > 100 cc if not in MCA territory, OR - Imaging lesion consistent with acute hemorrhage, OR - Evidence of intraparenchymal tumor - Disability prior to the presenting stroke - Standard contraindications to IV alteplase within 3 hrs of symptom onset including: - Head trauma, myocardial infarction, or stroke within past 3 months - Gastrointestinal or urinary tract hemorrhage within past 21 days - Major surgery within past 14 days - Arterial puncture at non-compressible site within past 7 days - Any history of intracranial hemorrhage (excepting those < 5 chronic microbleeds on MRI - Elevated blood pressure defined by systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, OR treatments requiring aggressive measures to achieve acceptable levels - Treatment with heparin within past 48 hrs AND an activated partical thromboplasting time outside normal - Blood glucose < 50 mg/dL - International normalized ratio > 1.7 - Platelet count < 100,000/cm3 - Treatment with a direct thrombin inhibitor (dabigatran) or a factor Xa inhibitor (apixaban, rivaroxaban,edoxaban) within the last 48 hrs - Allergic reaction to study drug or aspirin - Females of childbearing age who are known to be pregnant and/or lactating - Inability to swallow aspirin or aspirin placebo capsule - Other serious illness that would confound the clinical outcome at 90 days - Current or recent (within 3 months) participation in another investigational drug treatment protocol - Anticipated inability to obtain 3-month follow-up assessments - Previous enrollment in PRISMS - Any other condition deemed by the investigator that would pose hazard to the patient with alteplase treatment
3 Sep '16
A location was updated in Bradenton.
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The overall status was updated to "Recruiting" at Name Unavailable.
3 Aug '16
A location was updated in Loveland.
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The overall status was updated to "Recruiting" at Name Unavailable.
6 Jul '16
A location was updated in Pittsburgh.
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The overall status was updated to "Recruiting" at Name Unavailable.
6 May '16
A location was updated in Danbury.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in York.
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The overall status was updated to "Recruiting" at Name Unavailable.
7 Apr '16
A location was updated in Ft. Lauderdale.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Lansing.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Philadelphia.
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The overall status was updated to "Terminated" at Name Unavailable.
3 Mar '16
A location was updated in Tucson.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Newport Beach.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Randallstown.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Royal Oak.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Winston-salem.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Hershey.
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The overall status was updated to "Terminated" at Name Unavailable.
3 Feb '16
A location was updated in Chapel Hill.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Philadelphia.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Orangeburg.
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The overall status was updated to "Completed" at Name Unavailable.
5 Jan '16
A location was updated in San Antonio.
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The overall status was updated to "Recruiting" at Name Unavailable.
4 Nov '15
A location was updated in Hackensack.
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The overall status was updated to "Terminated" at Name Unavailable.
3 Sep '15
A location was updated in Santa Monica.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Fairfield.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Detroit.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Golden Valley.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Allentown.
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The overall status was updated to "Terminated" at Name Unavailable.
4 Aug '15
A location was updated in Los Angeles.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Fairfield.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Houston.
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The overall status was updated to "Recruiting" at Name Unavailable.
3 Jul '15
A location was updated in Kansas City.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Winston-salem.
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The overall status was updated to "Terminated" at Name Unavailable.
7 May '15
A location was updated in Phoenix.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Fairfield.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Edgewood.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Florence.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Ft. Thomas.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Louisville.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Lansing.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Jackson.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Philadelphia.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Harlingen.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Salt lake city.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Fairfax.
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The overall status was updated to "Recruiting" at Name Unavailable.
6 Feb '15
A location was updated in Miami.
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The overall status was updated to "Recruiting" at Name Unavailable.
3 Feb '15
The Summary of Purpose was updated.
New
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV Activase placebo and one dose of oral aspirin 325 mg.
Old
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time eit her 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one do se of IV Activase placebo and one dose of oral aspirin 325 mg.
A location was updated in Ft. Lauderdale.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Lexington.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Baltimore.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Randallstown.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cleveland.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Dayton.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Portland.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Knoxville.
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The overall status was updated to "Recruiting" at Name Unavailable.
27 Jan '15
A location was updated in Brooklyn.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Portland.
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The overall status was updated to "Recruiting" at Name Unavailable.
26 Dec '14
A location was updated in Fullerton.
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The overall status was updated to "Recruiting" at Name Unavailable.
16 Dec '14
A location was updated in Buffalo.
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The overall status was updated to "Recruiting" at Name Unavailable.
21 Nov '14
A location was updated in Danbury.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Pontiac.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Royal Oak.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Columbia.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Hackensack.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Summit.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Toms River.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Chapel Hill.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Akron.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cleveland.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Philadelphia.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in La Crosse.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Madison.
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The overall status was updated to "Recruiting" at Name Unavailable.
23 Oct '14
A location was updated in Englewood.
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The overall status was updated to "Recruiting" at Name Unavailable.
17 Oct '14
A location was updated in Fort Collins.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Seattle.
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The overall status was updated to "Recruiting" at Name Unavailable.
10 Sep '14
A location was updated in Chicago.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Chicago.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in St. Louis.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in New York.
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The overall status was updated to "Recruiting" at Name Unavailable.
7 Aug '14
A location was updated in Elk Grove Village.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Brooklyn.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Allentown.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Columbia.
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The overall status was updated to "Recruiting" at Name Unavailable.
18 Jul '14
A location was updated in Fort Wayne.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Cincinnati.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Houston.
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The overall status was updated to "Recruiting" at Name Unavailable.
3 Jul '14
A location was updated in Birmingham.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in La Jolla.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Columbus.
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The overall status was updated to "Recruiting" at Name Unavailable.
12 Jun '14
A location was updated in Newark.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Toledo.
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The overall status was updated to "Recruiting" at Name Unavailable.
30 May '14
The Summary of Purpose was updated.
New
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time eit her 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one do se of IV Activase placebo and one dose of oral aspirin 325 mg.
Old
PRISMS is a double-blind, multicenter, randomized, Phase IIIb study to evaluate the efficacy and safety of intravenous (IV) Activase in patients with mild acute ischemic strokes that do not appear to be clearly disabling. Patients will be randomized in a 1:1 ratio to receive within 3 hours of last known well time either 1) one dose of IV Activase and one dose of oral aspirin placebo or 2) one dose of IV Activase placebo and one dose of oral aspirin 325 mg.
15 May '14
A location was updated in Pittsburgh.
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The overall status was updated to "Recruiting" at Name Unavailable.
1 May '14
A location was updated in Newport Beach.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Reno.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Greensboro.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Chattanooga.
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The overall status was updated to "Recruiting" at Name Unavailable.
22 Apr '14
A location was updated in Charleston.
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The overall status was updated to "Recruiting" at Name Unavailable.
A location was updated in Morgantown.
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The overall status was updated to "Recruiting" at Name Unavailable.
16 Apr '14
A location was updated in Golden Valley.
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The overall status was updated to "Terminated" at Name Unavailable.
A location was updated in Orangeburg.
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The overall status was updated to "Completed" at Name Unavailable.
12 Mar '14
Trial name was updated.
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A Study of the Efficacy and Safety of Activase (Alteplase) in Patients With Mild Stroke (PRISMS)