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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
Scripps Health
Information provided by (Responsible Party):
Thomas M Hemmen, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01150266
First received: June 23, 2010
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Ischemic Stroke
Drug: Alteplase (tPA)
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: Alteplase for Waking Onset STROKE

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Symptomatic Intracranial Hemorrhage [ Time Frame: 0-72 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    An improvement of the NIHSS is defined as a 4-point improvement in the NIHSS, or NIHSS 0 measured 24 hours after treatment.


Enrollment: 0
Study Start Date: August 2011
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alteplase
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.
Drug: Alteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
Other Names:
  • Activase®
  • rt-PA
  • t-PA
  • tPA

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.

  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Stroke or serious head trauma within the preceding 3 months
  2. Major surgery or serious trauma within 14 days
  3. History of intracranial hemorrhage
  4. Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.
  5. Rapidly improving or minor symptoms
  6. Symptoms suggestive of subarachnoid hemorrhage.
  7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days.
  8. Arterial puncture at a non-compressible site within the previous 7 days
  9. Seizure at the onset of stroke and considered the cause for the neurological symptom.
  10. 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
  11. 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.
  12. Active internal bleeding
  13. Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
  14. Lumbar puncture within 7 days.
  15. 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.
  16. Unable to obtain CTA or perfusion brain studies (PWI or CTP)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150266

Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92037-0979
Sponsors and Collaborators
University of California, San Diego
Scripps Health
  More Information

No publications provided

Responsible Party: Thomas M Hemmen, Director, UCSD Stroke Center, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01150266     History of Changes
Other Study ID Numbers: AWOKE, 5P50NS044148
Study First Received: June 23, 2010
Last Updated: September 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
stroke
ischemia
thrombolysis
thrombolytics
tPA
rt-PA
t-PA
Activase®
Alteplase
wake-up stroke
waking onset stroke
sleep

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
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 July 24, 2014