Status:
TERMINATED
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Neurological Emergencies Treatment Trials Network (NETT)
Medical University of South Carolina
Conditions:
Ischemic Attack, Transient
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral...
Detailed Description
Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with T...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 28 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2018
Estimated Enrollment :
4881 Patients enrolled
Trial Details
Trial ID
NCT00991029
Start Date
May 28 2010
End Date
April 9 2018
Last Update
December 4 2018
Active Locations (210)
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1
Chandler Regional Medical Center
Chandler, Arizona, United States, 85224
2
Banner University Medical Center - Tucson Campus
Tucson, Arizona, United States, 85724
3
Mercy San Juan Medical Center
Carmichael, California, United States, 95608
4
UCSD Health La Jolla
La Jolla, California, United States, 92037