Platelet-Oriented Inhibition in New TIA and Minor Ischemic stroke

• Research type

  Research Study

• Full title

  Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, a randomized, double blind, multicentre clinical trial

• IRAS ID

  123518

• Contact name

  James Kennedy

• Contact email

  James.Kennedy@rdm.ox.ac.uk

• Sponsor organisation

  University of California San Francisco Stroke Sciences Group

• Eudract number

  2013-001185-41

• Clinicaltrials.gov Identifier

  NCT00991029

• Research summary

  The purpose of this study is to determine the safety and effectiveness of the combination of low-dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients recovering from stroke. The POINT trial has been designed to find out whether the combination of aspirin and clopidogrel reduces the risk of stroke, heart attacks and other complications compared to aspirin alone in patients.
  The trial will be completed in 7 years with a total of 4150 patients in 210 hospitals participating in this research study.
  Participants will be screened and randomized after presentation to the emergency department. Appropriate tests and assessments are performed to determine eligibility (an eligibility form is completed along-with Inclusion/Exclusion criteria). Consent will be obtained prior to any trial related procedures. Subjects already taking aspirin or another antiplatelet agent will be randomized by the treating physician to Group 1 or Group 2. Group 1; participants randomized to clopidogrel receive 600mg (eight 75mg tablets) and then instructed to take one tablet on Day 2 and 1 additional tablet each day through the 90 Day follow up. Group 2; Those not randomized to clopidogrel will receive eight tablets of an identical appearing placebo on Day 1, and instructed to take one tablet each day on days 2 through 90.
  All subjects will also take 50-325mg of open label aspirin daily; dose determined by treating physician (of 162mg daily x 5 days, followed by 81mg daily strongly recommended. After week 1 a visit is scheduled and if required an Event visit (if subject experiences an outcome event such as stroke), 30 Day telephone contact and a 90 Day follow up visit.
  In addition participants will be asked if they wish to consent to a biomarker sub study

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0470

• Date of REC Opinion

  14 Nov 2013

• REC opinion

  Further Information Favourable Opinion