Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ischemic Stroke |
Drug: Alteplase (iv t-PA) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety of Intravenous Thrombolysis for Wake-up Stroke |
- Frequency of symptomatic hemorrhagic transformation Safety of iv t-PA in wake up stroke patients [ Time Frame: 24 hr ] [ Designated as safety issue: Yes ]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 [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: off label rt-PA used
off label rt-PA used on all subject enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.
|
Drug: Alteplase (iv t-PA)
0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Jennifer M Garrett, RN | 713-500-7183 | jennifer.m.garrett@uth.tmc.edu |
| United States, Alabama | |
| University of Alabama | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Andre Alexandrov, MD | |
| Principal Investigator: Andre Alexandrov, MD | |
| United States, Colorado | |
| Swedish Medical Center | Recruiting |
| Englewood, Colorado, United States, 80113 | |
| Contact: Chris Fanale, MD | |
| Principal Investigator: Chris Fanale, MD | |
| United States, Texas | |
| UT-Houston Health Science Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jennifer M Garrett, RN 713-500-7183 jennifer.m.garrett@uth.tmc.edu | |
| Principal Investigator: Sean I Savitz, MD | |
| Sub-Investigator: Andrew Barreto, MD | |
| Principal Investigator: | Sean I Savitz, MD | UT-Houston Health Science Center |
| Principal Investigator: | Andrew Barreto, MD | Study Co-PI |
More Information
No publications provided
| Responsible Party: | Sean Savitz, MD, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01183533 History of Changes |
| Other Study ID Numbers: | HSC-MS-10-0195 |
| Study First Received: | August 16, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Wake-Up Stroke Ischemic stroke ischemic stroke patients who wake-up with their symptoms |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Ischemia Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
Brain Infarction Brain Ischemia Tissue Plasminogen Activator Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents |
ClinicalTrials.gov processed this record on May 22, 2013