Safety of Intravenous Thrombolysis for Wake-up Stroke "Wake-Up Stroke"

Completed

Phase 2 Results

Update History

26 Nov '14
The Summary of Purpose was updated.
New
The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV t-PA) in ischemic stroke patients who present to the emergency department (ED) after awakening with the symptoms of suspected ischemic stroke.
Old
The purpose is to demonstrate the safety of IV t-PA in ischemic stroke patients who present to the ED after awakening with the symptoms of suspected ischemic stroke.
The description was updated.
New
This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the National Institutes of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram (CTA) and computed tomographic perfusion (CTP), the incidence of large vessel occlusion will be quantified.
Old
This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days. For patients that have CTA and CTP, the incidence of large vessel occlusion will be quantified.
Trial was updated to "Phase 2."
The eligibility criteria were updated.
New
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS (National Institutes of Health Stroke Scale) ≤25 - Blood Pressure ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - IV t-PA must be given within 3 hours of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 middle cerebral artery (MCA) territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 185 mmHg or diastolic BP > 110 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal (partial thromboplastin time) PTT - Oral anticoagulants & an (international normalized ratio) INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with (intra-arterial therapy) IAT If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol
Old
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS ≤25 - BP ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - t-PA must be given within 3 hrs of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 185 mmHg or diastolic BP > 110 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal PTT - Oral anticoagulants & an INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol
A location was updated in Birmingham.
New
The overall status was removed for University of Alabama.
A location was updated in Englewood.
New
The overall status was removed for Swedish Medical Center.
A location was updated in Houston.
New
The overall status was removed for UT-Houston Health Science Center.
22 Feb '12
The eligibility criteria were updated.
New
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS ≤25 - BP ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - t-PA must be given within 3 hrs of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 185 mmHg or diastolic BP > 110 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal PTT - Oral anticoagulants & an INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol
Old
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS ≤25 - BP ≤180 mmHg systolic & ≤105 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - t-PA must be given within 3 hrs of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 180 mmHg or diastolic BP > 105 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal PTT - Oral anticoagulants & an INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS ≤25 - BP ≤180 mmHg systolic & ≤105 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - t-PA must be given within 3 hrs of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 180 mmHg or diastolic BP > 105 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal PTT - Oral anticoagulants & an INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol
Old
Inclusion Criteria: - Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well. - 18 to 80 years old - NIHSS ?25 - BP ?180 mmHg systolic & ?105 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment - t-PA must be given within 3 hrs of awakening from sleep - Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment Exclusion Criteria: - CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage - Prior ischemic stroke within 3 months of the presenting event - History of intracranial hemorrhage - Known secured or unsecured cerebral aneurysm or vascular malformation - Inability to control systolic BP > 180 mmHg or diastolic BP > 105 mmHg with IV anti-hypertensive medications - Known coagulopathy or evidence of active bleeding - Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event - Gastrointestinal or genitourinary bleeding within 14 days of the event - Treated with IV heparin within the previous 24 hours & an abnormal PTT - Oral anticoagulants & an INR >1.7 - Platelet count <100,000 - Venous glucose either <50 or >450 - Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol