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

NCT01150266 | Withdrawn Phase 1 DMC

• 2 other identifiers: AWOKE5P50NS044148
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  0-72 hours

Secondary Outcomes (2)

• Modified Rankin Scale

  90 days

• National Institutes of Health Stroke Scale (NIHSS)

  24 hours

Study Arms (1)

Alteplase

EXPERIMENTAL

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)

Interventions

Alteplase (tPA) DRUG

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

Also known as: Activase®, rt-PA, t-PA, tPA

Alteplase

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Scripps Health: collaborator

Study Sites (1)

University of California, San Diego

San Diego, California, 92037-0979, United States

Location

Related Links

• UCSD Stroke Center

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Ischemia

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, UCSD Stroke Center

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Last Updated: September 13, 2013

Record last verified: 2013-09

Locations

US (1)