Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke "CLOTBUST-ER"

Terminated

Phase 3 Results N/A

Update History

8 Apr '15
A location was updated in Redmond.
New
The overall status was removed for Cerevast Therapeutics, Inc..
9 Sep '14
The description was updated.
New
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score ordinal shift analysis). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.
Old
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score 0-1). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Males or females 18 - 80 years of age 2. Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms 3. No signs of intracranial bleeding on assessment by non-contrast CT 4. Subjects with neurological deficits of a total NIHSS score ≥ 10 points 5. Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards 6. SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus 7. Pre-morbid modified Rankin score of 0-1 8. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations 9. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations 10. For subjects in the optional arterial recanalization substudy: 1. Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions 2. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA or MRA Exclusion Criteria: 1. Subjects with primary intra-arterial thrombolysis 2. Females who are pregnant or breast feeding 3. Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment 4. Subjects with any standard contraindication for intravenous tPA therapy 5. Significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study
Old
Inclusion Criteria: 1. Males or females 18 - 80 years of age 2. Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms 3. No signs of intracranial bleeding on assessment by non-contrast CT 4. Subjects with neurological deficits of a total NIHSS score ≥ 10 points 5. Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards 6. SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus 7. Pre-morbid modified Rankin score of 0-1 8. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations 9. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations 10. For subjects in the optional arterial recanalization substudy: 1. Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions 2. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA Exclusion Criteria: 1. Subjects with primary intra-arterial thrombolysis 2. Females who are pregnant or breast feeding 3. Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment 4. Subjects with any standard contraindication for intravenous tPA therapy 5. Significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study
16 May '13
The description was updated.
New
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score 0-1). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 24 hours of treatment.
Old
The primary objective of this trial is to provide information regarding the efficacy of a combined treatment with transcranial US and systemic tPA (Target group) compared to systemic tPA alone (Control group) in subjects with acute ischemic stroke. The primary efficacy endpoint is functional outcome at 3 months from stroke onset (modified Rankin Score 0-1). The primary safety endpoint is the proportion of subjects in the Target vs Control group experiencing symptomatic intracranial hemorrhage (sICH) within 36 hours of treatment.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Males or females 18 - 80 years of age 2. Subjects presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities but no more than 4.5 hours from onset of symptoms 3. No signs of intracranial bleeding on assessment by non-contrast CT 4. Subjects with neurological deficits of a total NIHSS score ≥ 10 points 5. Subjects that in the opinion of the treating physician require treatment with full dose IV tPA as standard of care per institutional standards 6. SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications prior to tPA bolus 7. Pre-morbid modified Rankin score of 0-1 8. Provision of informed consent as demonstrated by the subject's signature or by the signature of the subject's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations 9. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations 10. For subjects in the optional arterial recanalization substudy: 1. Occlusion located in the intracranial carotid tee through mid M2 or proximal A2, or intracranial vertebrobasilar or P1/proximal P2 segments or tandem lesions 2. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min for patients undergoing CTA Exclusion Criteria: 1. Subjects with primary intra-arterial thrombolysis 2. Females who are pregnant or breast feeding 3. Subjects receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment 4. Subjects with any standard contraindication for intravenous tPA therapy 5. Significant concurrent medical/neurological conditions or test values that, in the opinion of the investigator, pose significant risk to the subject and warrant exclusion from the study
Old
Inclusion Criteria: - Males or females 18 years of age or older; - Patients presenting within timeframe for intravenous tPA treatment approved by local regulatory authorities and non-contrast head CT showing no signs of intracranial bleeding; - Patients with neurological deficits of a total NIHSS score greater than or equal to 10 points, and that in the opinion of the treating physicians patients require treatment with full dose IV tPA as standard of care; - SBP < 185 mmHg and DBP < 105 mmHg at baseline or after treatment of hypertension with medications; - Provision of informed consent as demonstrated by the patient's signature or by the signature of the patient's authorized legal representative on the Informed Consent Form in accordance with all local and national regulations; - Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and national regulations. Exclusion Criteria: - NIHSS < 10 points; - Evidence of hemorrhage on non-contrast head CT scan; - Patients with a history of severe uncontrollable hypertension; - Patients with primary intra-arterial thrombolysis; - Female of child bearing potential, pregnant or breast feeding; - Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment; - Patients with any standard contraindication for intravenous tPA therapy; - Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study.
A location was updated in Redmond.
New
The overall status was removed for Cerevast Therapeutics, Inc..
19 Jun '12
Trial acronym was updated.
New
CLOTBUST-ER
Trial name was updated.
New
Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial of the Combined Lysis of Thrombus With Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke
The Summary of Purpose was updated.
New
This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
Old
This is a randomized, active controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.
A location was updated in Redmond.
New
The overall status was removed for Cerevast Therapeutics, Inc..