Platelet oriented inhibition in new transient ischaemic attack (TIA) and minor ischemic stroke

Phase 4

Completed

• Conditions: Topic: Stroke Research Network, Injuries and Emergencies; Subtopic: Acute Care, Injuries and Emergencies (all Subtopics); Disease: In hospital study, Injuries and Emergencies; Circulatory System; Stroke, not specified as haemorrhage or infarction

• Registration Number: ISRCTN73630073
• Lead Sponsor: niversity of California, San Francisco

Brief Summary

2013 protocol in https://www.ncbi.nlm.nih.gov/pubmed/23879752 (added 24/01/2020) 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/29766750 (added 24/01/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-25
• Study Completion: 2016-06-30
• Last Update Posted: 10 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4881

Inclusion Criteria

Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
1. 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
2. Ability to randomize within 12 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. Age <18 years.
2. TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
3. In the judgement 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.
4. Receipt of any intravenous or intraarterial thrombolysis within 1 week prior to index event.
5. Gastrointestinal bleed or major surgery within 3 months prior to index event.
6. History of nontraumatic intracranial hemorrhage.
7. 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).
8. Qualifying ischemic event induced by angiography or surgery.
9. Severe noncardiovascular comorbidity with life expectancy <3 months.
10. Contraindication to clopidogrel or aspirin:
10.1. Known allergy
10.2. 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)
10.3. Haemostatic disorder or systemic bleeding in the past 3 months
10.4. Current thrombocytopenia (platelet count <100 x109/l) or neutropenia/granulocytopenia (<1 x109/l)
10.5. History of drug induced haematologic or hepatic abnormalities
11. Anticipated requirement for long term (>7 day) nonstudy antiplatelet drugs (e.g., dipyridamole, clopidogrel,
iclopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
12. Not willing or able to discontinue prohibited concomitant medications.
13. Inability to swallow medications.
14. 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).
15. Unavailability for followup.
16. Signed and dated informed consent not obtained from patient.
17. Other neurological conditions that would complicate assessment of outcomes during follow up.
18. Ongoing treatment in another study of an investigational therapy, or treatment in such a study within the last 7 days.
19. Previously enrolled in the POINT study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevention of major ischemic vascular events at 90 days; Timepoint(s): The primary outcome of the trial is to determine whether clopidogrel 75mg/day by mouth after a load

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration