Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial

Study ID
STU 072011-004

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern University Hospital—St. Paul
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital– Zale Lipshy
  • Parkland Health & Hospital System

Contact
Jan Cameron Watts
214-648-0363
jan.cameronwatts@utsouthwestern.edu

Principal Investigator
Mark Johnson

Summary

4,150 subjects will be recruited from 210 centers in partnership with the ninDS neurological emergencies Treatment Trials (neTT) network and the PoinT Clinical Research Collaboration (CRC). it is a prospective, randomized, double-blind, multicenter trial with the primary null hypothesis that, in patients with Tia or minor ischemic stroke treated with aspirin 50-325 mg/day, there is no difference in the event-free survival at 90 days in those treated with clopidogrel
(600 mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12 hours of time last known free of new ischemic symptoms.
The goal of recruitment at this research center will be 25 subjects. The target patients include patients with a Tia or minor ischemic stroke and who are being treated with aspirin 50-325 mg/day. The aspirin's dose will be at the discretion of the treating physician; however, it is strongly recommended for the purposes of this study that patients take 162mg of oral aspirin daily for the first 5 days after being randomized followed by 81mg oral aspirin daily for the duration of the study. eligible patients are randomized within 12 hours of time last known free of new ischemic symptoms to either the active drug (clopidogrel) group or the placebo group. The patients are to receive a loading dose of 600mg oral of clopidogrel/placebo within 2 hours of randomization.This loading dose will be given to patients who were already on clopidogrel. Pt who initially presented to an outside eD and were loaded with clopidogrel can also be elaluated for participation in this study. From day 2 through day 90, randomized subjects will take 75mg daily of oral clopidogrel or placebo. The study will provide the clopidogrel/placebo for the purposes and duration of the study. The duration of the study for each patient is 90 days. any other antiplatelet and anticoagulant agents except aspirin will be discontinued prior to randomization.
Primary outcome Measures include new ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death within 90 days.
Secondary outcome Measures will be evaluated, separately including risk of ischemic stroke, intracranial hemorrhage, and major hemorrhage, and the composite of the primary outcome and major hemorrhage within 90 days.
Follow up window of 150 days from randomization.

Participant Eligibility


* Neurologic deficit (based on history or exam) 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
2. 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.