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SOCRATES


Title A Randomized, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischemic Stroke or TIA
Therapeutic Area Stroke, Transient Ischemic Attack
Principal Investigator David E. Thaler, MD, PhD
Min Age 40 Years
Gender Both
Contact Haley Huggins
617-636-7606
More Information http://clinicaltrials.gov/ct2/show/NCT01994720

Overview

This study is to compare the effect and safety of the investigational drug, ticagrelor, given twice daily compared to aspirin, given once daily for the prevention of death, heart attack, and stroke in patients with acute ischemic stroke or TIA. Ticagrelor is not FDA approved for these indications.

Study Details

Inclusion Criteria

  • Either has acute ischemic stroke or high-risk TIA with symptoms occurring within 24 hours of randomization
  • CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess that could explain symptoms

Exclusion Criteria

  • Known hypersensitivity to ticagrelor or aspirin
  • History of atrial fibrillation, ventricular aneurysm, or suspicion of cardioembolic pathology for TIA or stroke
  • Renal failure requiring dialysis

Study Requirements

The subject will be randomly assigned to 1 of 2 study treatments:

Study Treatment 1: On day 1 you will receive Ticagrelor 180 mg and aspirin placebo. After this you will receive ticagrelor 90 mg plus aspirin placebo each morning for the remaining 90 days. Each evening you will receive ticagrelor 90 mg

Study Treatment 2: On Day 1 you will receive aspirin 300 mg plus ticagrelor placebo. After this you will receive aspirin 100 mg each morning plus ticagrelor placebo for the remaining 90 days. Each evening you will receive ticagrelor placebo.

Number of research visits: 6 visits total including enrollment visit, 1 week in-office visit, 1 month telephone visit, 2 month telephone visit, 3 month in-office visit, and 4 month in-office visit

Length of participation: 120 days

Number of CT scans: 1 per standard of care

Assessments: mRS, NIHSS, ASCOD Classification of Stroke, Health Economic Assessment, ABCD2 Score for TIA patients, and Compliance reminder