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Study for the Use of Alteplase in Patients Who Awaken With Stroke (AWOKE)

Primary Purpose

Ischemic Stroke

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Alteplase (tPA)

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke, ischemia, thrombolysis, thrombolytics, tPA, rt-PA, t-PA, Activase®, Alteplase, wake-up stroke, waking onset stroke, sleep

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥22
Stroke upon awakening
Measurable deficit by NIHSS
No deficit before sleep or last seen normal before to sleep
Head CT with no evidence of intracranial hemorrhage.
Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit.
Written informed consent signed and dated by the patient (or patient's authorized representative)
Core lesion: ASPECTS ≥7 on MRI-DWI, CTP-CBV or CTA source imaging.
Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP

Exclusion Criteria:

Stroke or serious head trauma within the preceding 3 months
Major surgery or serious trauma within 14 days
History of intracranial hemorrhage
Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.
Rapidly improving or minor symptoms
Symptoms suggestive of subarachnoid hemorrhage.
Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days.
Arterial puncture at a non-compressible site within the previous 7 days
Seizure at the onset of stroke and considered the cause for the neurological symptom.
Patients who are taking anticoagulants or who had received heparin within the 48 hours preceding the onset of stroke and have an elevated partial-thromboplastin time, INR>1.7 or platelet counts below 100,000/mm3
Finger sticks glucose below 50 mg/dl (2.7 mmol/ Lt) or above 400 mg per deciliter (22.2 mmol/Lt) and considered the cause for the neurological symptom.
Active internal bleeding
Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
Lumbar puncture within 7 days.
Known co-morbid conditions likely to complicate therapy or interfere with patient assessment, such us: heart failure stage 4, severe dementia, end-stage AIDS, pericarditis, cirrhosis or known cancer.
Unable to obtain CTA or perfusion brain studies (PWI or CTP)

Sites / Locations

University of California, San Diego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alteplase

Arm Description

Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking.

Outcomes

Primary Outcome Measures

Symptomatic Intracranial Hemorrhage

sICH is defined as any confluent dense hematoma occupying greater than 30% of the infarcted area with substantial space occupying effect, or any brain hemorrhage outside the infarcted area that occurs within 72 hours of tPA treatment and is associated with an increase of at least 4 points in the NIHSS.

Secondary Outcome Measures

Modified Rankin Scale

A good outcome is defined as a modified Rankin Scale (mRS) of ≤1 or return to baseline mRS.

National Institutes of Health Stroke Scale (NIHSS)

An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.

Full Information

NCT ID

NCT01150266

First Posted

June 23, 2010

Last Updated

September 11, 2013

Sponsor

University of California, San Diego

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), Scripps Health

1. Study Identification

Unique Protocol Identification Number

NCT01150266

Brief Title

Study for the Use of Alteplase in Patients Who Awaken With Stroke

Acronym

AWOKE

Official Title

Alteplase for Waking Onset STROKE

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Withdrawn

Study Start Date

August 2011 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, San Diego

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS), Scripps Health

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a pilot study of thrombolytic therapy in patients with ischemic stroke who present with stroke symptoms upon awakening.

Detailed Description

Patients with ischemic stroke are currently only eligible for the treatment with intravenous thrombolysis if the stroke is diagnosed within 4.5 hours from known onset of symptoms. Many patients awaken with stroke and are excluded from this therapy, following current guidelines. Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke

Keywords

stroke, ischemia, thrombolysis, thrombolytics, tPA, rt-PA, t-PA, Activase®, Alteplase, wake-up stroke, waking onset stroke, sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alteplase

Arm Type

Experimental

Arm Description

Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking.

Intervention Type

Drug

Intervention Name(s)

Alteplase (tPA)

Other Intervention Name(s)

Activase®, rt-PA, t-PA, tPA

Intervention Description

0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.

Primary Outcome Measure Information:

Title

Symptomatic Intracranial Hemorrhage

Description

Time Frame

0-72 hours

Secondary Outcome Measure Information:

Title

Modified Rankin Scale

Description

A good outcome is defined as a modified Rankin Scale (mRS) of ≤1 or return to baseline mRS.

Time Frame

90 days

Title

National Institutes of Health Stroke Scale (NIHSS)

Description

An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥22 Stroke upon awakening Measurable deficit by NIHSS No deficit before sleep or last seen normal before to sleep Head CT with no evidence of intracranial hemorrhage. Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit. Written informed consent signed and dated by the patient (or patient's authorized representative) Core lesion: ASPECTS ≥7 on MRI-DWI, CTP-CBV or CTA source imaging. Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP Exclusion Criteria: Stroke or serious head trauma within the preceding 3 months Major surgery or serious trauma within 14 days History of intracranial hemorrhage Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures. Rapidly improving or minor symptoms Symptoms suggestive of subarachnoid hemorrhage. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days. Arterial puncture at a non-compressible site within the previous 7 days Seizure at the onset of stroke and considered the cause for the neurological symptom. Patients who are taking anticoagulants or who had received heparin within the 48 hours preceding the onset of stroke and have an elevated partial-thromboplastin time, INR>1.7 or platelet counts below 100,000/mm3 Finger sticks glucose below 50 mg/dl (2.7 mmol/ Lt) or above 400 mg per deciliter (22.2 mmol/Lt) and considered the cause for the neurological symptom. Active internal bleeding Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy). Lumbar puncture within 7 days. Known co-morbid conditions likely to complicate therapy or interfere with patient assessment, such us: heart failure stage 4, severe dementia, end-stage AIDS, pericarditis, cirrhosis or known cancer. Unable to obtain CTA or perfusion brain studies (PWI or CTP)

Facility Information:

Facility Name

University of California, San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92037-0979

Country

United States

12. IPD Sharing Statement

Links:

URL

http://heartcenter.ucsd.edu/stroke

Description

UCSD Stroke Center

Learn more about this trial

Study for the Use of Alteplase in Patients Who Awaken With Stroke

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