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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Cardiology
Title   Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke Trial (POINT) (Cardiology)
Description   This study examines whether the combination of low-dose aspirin and clopidogrel increases the effectiveness in reducing the risk of stroke, heart attacks, and other complications in patients who have just had a transient ischemic attack or a minor stroke. The study will also compare the risks of the combination with the risks from aspirin alone.
IRB Number   Pro4684
Inclusion/Notes   INCLUSION:
  • 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 ABCD2 score >4
    OR
    -Minor ischemic stroke: residual deficit with NIHSS <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:
  • 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 the 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 non-traumatic 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 hepatic insufficiency (prior or concurrent diagnosis, with 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)

  • History of drug-induced hematologic or hepatic abnormalities.

  • Anticipated requirement for long-term (>7 days) nonstudy antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).

  • Not willing or able to discontinue prohibited concomitant medications.

  • Inability to swallow medications.

  • 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).

  • 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 investiational therapy, or treatment in such a study within the last 7 days.

  • Previously enrolled in the POINT study.
Status   Recruiting
Location   Texas Health Presbyterian Hospital Dallas
Principal Name    Samir Hasmukh Shah MD
Contact Name   Melissa Perkins
Phone   (214) 345-8339

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