A Study of Clopidogrel for the Prevention of TIA and Minor Ischemic Stroke

Overview

About this study

The purpose of this study is to assess the effectiveness of Clopidogrel for preventing the occurance of transient ischemic attacks (TIA) and minor strokes.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 
      • ABCD2 score of ≥ 4
    • Minor ischemic stroke
      • Residual deficit with NIHSS of ≤ 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 dose 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
      • 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
    • Pre or post menopausal woman within 12 months of last menses without a negative pregnancy test 
    • 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 or treatment in such a study within the last 7 days
  • Previously enrolled in the POINT study

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Maria Aguilar, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20314929

Mayo Clinic Footer