The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary goal of the research is to determine if 10 days of dual anti-platelet treatment is as effective as 30 days of similar treatment in the prevention of stroke, myocardial ischemia (MI) and death in patients with TIAs and minor stroke.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria

1. Neurologic 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 age, blood pressure, clinical features, duration of TIA and presence of diabetes (ABCD2) score >4 OR Minor ischemic stroke: residual deficit with NIHSS ≤3 at the time of randomization.

2. Ability to randomize within 24 hours of time last known free of new ischemic symptoms.

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

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

Exclusion Criteria

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

2. 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 the evaluation for eligibility.

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

4. Gastrointestinal bleed or major surgery within 3 months prior to index event. History of non-traumatic intracranial hemorrhage.

5. 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).

6. Qualifying ischemic event induced by angiography or surgery.

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

8. Contraindication to clopidogrel or aspirin:

• Known allergy

• Severe renal (serum creatinine >2 mg/dL) 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 x109/l) or neutropenia/granulocytopenia (<1 x109/l) o History of drug-induced hematologic or hepatic abnormalities

9. Anticipated requirement for long-term (>10 days) nonstudy antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or non steroidal anti inflammatory drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).

10. Not willing or able to discontinue prohibited concomitant medications. Inability to swallow medications.

11. At risk for pregnancy: premenopausal or postmenopausal 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).

12. 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, or treatment in such a study within the last 7 days.