Aspirin or Aspirin and Plavix in treating new TIA (mini-stroke) and minor ischemic stroke

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"Which is better for reducing the risk of stroke, heart attacks and other complications, aspirin and clopidogrel (Plavix), or aspirin alone?"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Transient Ischemic Attack (TIA), minor ischemic stroke, aspirin
Type:
Drug study, Phase 3
Investigator:
Description
The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients who have just had a TIA (mini-stoke) or minor ischemic stroke.

Patients who have had a TIA have a higher risk of developing a stroke. Recognizing and treating TIAs can reduce your risk of a stroke. Often, medication to prevent blood clots from forming is used to prevent a stroke in patients with blockage of one of the arteries in the brain. Low-dose aspirin has been shown to be effective in preventing strokes and heart attacks in patients who have had a TIA. Clopidogrel is another medication that is used to prevent strokes and heart attacks in patients at risk for these problems.
Clopidogrel is a type of medication called an antiplatelet drug, and it works by helping to keep platelets (small blood cells needed for normal blood clotting) in the blood from sticking together and forming harmful blood clots. This helps your blood flow more easily, and provides more protection against a future heart attack or stroke. Clopidogrel is approved for the prevention of a second stroke, and is taken once per day. Aspirin has also been shown to be effective in helping to prevent a second stroke or TIA, and is approved in doses ranging from 50 to 325 mg per day.
This study requires
History and Physical
Neurological Evaluation
Study Medication Administration
Study visit/phone call at one week, 30 days, 90 days
Who can participate?
Inclusion Criteria:

- Neurological deficit (based on history or exam) attributed to focal brain ischemia and EITHER:

- High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score of (greater than or equal to) 4 OR

- Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3 at the time of randomization

- Ability to randomize within 12 hours of time last known free of new ischemic symptoms.

- Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.

- Ability to tolerate aspirin at a does of 50-325 mg/day.

Exclusion Criteria

- Age <18 years

- TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.

- In the judgment of the treating physician, a candidate for thrombolysis, endarterectomy or endovascular intervention, unless the subject declines both endarterectomy and endovascular intervention at the time of evaluation for eligibility.

- Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.

- Gastrointestinal bleed or major surgery within 3 months prior to index event.

- History of nontraumatic intracranial hemorrhage.

- Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).

- Qualifying ischemic event induced by angiography or surgery.

- Severe non-cardiovascular comorbidity with life expectancy <3 months.

- Contraindication to clopidogrel or aspirin.

- Known allergy

- Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency (prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or any resultant complication, such as variceal bleeding, encephalopathy, or icterus)

- Hemostatic disorder or systemic bleeding in the past 3 months

- Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1 x10^9/l)

- History of drug-induced hematologic or hepatic abnormalities

- Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).

- Inability to swallow medications.

- At risk for pregnancy: premenopausal or post menopausal woman within 12 months of last menses without a negative pregnancy test or not committing to adequate birth control (e.g., oral contraceptive, two methods of barrier birth control, or abstinence).

- Unavailability for follow-up.

- Signed and dated informed consent not obtained from patient.

- Other neurological conditions that would complicate assessment of outcomes during follow-up.

- Ongoing treatment in another study of an investigational therapy that may potentially interact with study drug, or treatment in such a study within the last 7 days.

- Previously enrolled in the POINT study.
Resources
Schedule
Study duration and period
90 days
Recruitment period
From March 14, 2016
Location
UC Davis Department of Emergency Medicine
4150 V Street
Suite 2100
Sacramento, CA 95817
Research Topic
Conditions:
  • Ischemic Attack, Transient

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