Safety of Intravenous Thrombolysis for Wake-up Stroke

NCT ID: NCT01183533

Last Updated: 2014-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-01-31

Brief Summary

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.

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 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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Alteplase (iv t-PA)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Activase®; Alteplase; tissue plasminogen activator; t-PA

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Sean Savitz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean I Savitz, MD

Role: PRINCIPAL_INVESTIGATOR

UT-Houston Health Science Center

Andrew D Barreto, MD

Role: PRINCIPAL_INVESTIGATOR

Study Co-PI

Locations

University of Alabama

Birmingham, Alabama, United States

Swedish Medical Center

Englewood, Colorado, United States

UT-Houston Health Science Center

Houston, Texas, United States

Countries

United States

References

Barreto AD, Fanale CV, Alexandrov AV, Gaffney KC, Vahidy FS, Nguyen CB, Sarraj A, Rahbar M, Grotta JC, Savitz SI; Wake-Up Stroke Investigators. Prospective, open-label safety study of intravenous recombinant tissue plasminogen activator in wake-up stroke. Ann Neurol. 2016 Aug;80(2):211-8. doi: 10.1002/ana.24700. Epub 2016 Jul 12.

Reference Type: DERIVED

PMID: 27273860 (View on PubMed)

Other Identifiers

HSC-MS-10-0195

Identifier Type: -

Identifier Source: org_study_id