The Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial is a prospective, randomized, double-blind, multicenter international 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 survival free of ischemic stroke, myocardial infarction, and ischemic vascular death at 90 days in those treated with clopidogrel (600 mg loading dose then 75 mg/day) compared to placebo when therapy is initiated within 12 hours of time last known free of new ischemic symptoms.
Methods: The primary endpoint is a composite outcome of new ischemic events: ischemic stroke, myocardial infarction or ischemic vascular death. Subjects are 18 years or older with high-risk TIA (ABCD2 score ≥ 4) or minor ischemic stroke (NIHSS ≤ 3) meeting eligibility criteria who can be randomized within 12 hours of the qualifying event. Follow-up is 90 days from randomization so event rates are high throughout the period of study. A total of 5,840 patients will be recruited. The first subject was enrolled on May 28, 2010; international sites joined in August 2013.
Principal Investigator: S. Claiborne Johnston, MD, PhD, The University of Texas at Austin
Co-Principal Investigators: J. Donald Easton, MD, University of California, San Francisco; Anthony S. Kim, MD, MAS, University of California, San Francisco
Contact: Mary Farrant, MBA, BSN, RN, University of California, San Francisco, Director, POINT Trial —UCSF Clinical Coordinating Center (CCC), San Francisco, California, 94158; Phone: 1-415-502-7304; Email: firstname.lastname@example.org
Planned Number of Centers: 225; Present Number: 195
Planned Number of Subjects: 5,840; Present Number: 4,586 (June 2017)
Sponsor: University of California, San Francisco (UCSF); National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators: Neurological Emergencies Treatment Trials Network (NETT); Statistics and Data Management Center (SDMC) at Medical University of South Carolina (MUSC); POINT Clinical Research Collaboration (POINT-CRC) at EMMES Corporation
Dates of Study: October 2009 - April 2021
ClinicalTrials.gov Identifier: NCT00991029 http://clinicaltrials.gov/ct2/show/NCT00991029?term=POINT&rank=1