Clinical Trial: The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack.10 vs 30 Days of Combination ASA and Clopidogrel Study

Brief Summary: The primary goal of the research is to determine if 10 days of dual anti-platelet treatment is as effective as 30 days of similar treatment in the prevention of stroke, myocardial ischemia (MI) and death in patients with TIAs and minor stroke.

Detailed Summary:

Transient Ischemic Attacks (TIAs) are common, easily misdiagnosed, not investigated appropriately and are often harbingers of disabling strokes. A TIA is best defined as an episode of neurological dysfunction caused by focal ischemia that lasts for less than 24 hours (very often less than an hour). Minor stroke (NIHSS of <3) is often lumped together with TIAs. The distinction between minor ischemic stroke and TIA is unimportant in terms of prognosis. Numerous studies have shown that short-term risk of stroke is high after TIA and minor ischemic stroke, particularly in the first few days, even in patients treated with aspirin, the current standard of care. In patients with TIAs and minor stroke effective therapies can significantly reduce the overall burden of stroke if initiated immediately. The recently completed CHANCE study comprising more than 5000 patients with TIAs and minor stroke showed that a short course of combination antiplatelet medications (ASA+clopidogrel) for 3 weeks significantly reduced the 90-day risk of stroke when compared to ASA treatment.

There are three trials where patients with TIAs and minor strokes were treated early after onset of symptoms with combination treatment with clopidogrel and ASA versus ASA alone. FASTER was a pilot trial based in Canada (5). It evaluated clopidogrel (300 mg load and 75 mg/day afterwards) on a background of aspirin in patients presenting within 24 hours of a TIA or minor stroke. The trial enrolled 392 patients. The risk of stroke (ischemic or hemorrhagic) at 90 days was 11% in those treated with aspirin alone and 7% in those treated with clopidogrel and aspirin, a non-significant 36% relative risk reduction (RRR) in this pilot trial (p=0.19). There were two Intra cerebral hemorrhages(ICHs) and these were both in patients treated with clopidogrel and ASA.

The recen
Sponsor: University of Alberta

Current Primary Outcome:

  • To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment [ Time Frame: 4 years prospective study ]
    Initiation of dual anti platelet treatment in high risk TIA patients within 24 hours of presentation
  • What is the feasibility and efficacy of the non-inferiority design [ Time Frame: 4 years ]
    If 10 days of dual anti platelet treatment has equal efficacy in stroke prevention as 30 days of dual anti platelet treatment in patients with recent high risk TIAs


Original Primary Outcome:

  • to test if 10 days of dual anti platelet treatment is similar to 30 days treatment in TIAs [ Time Frame: 4 years prospective study ]
    Initiation of dual anti platelet treatment in high risk TIA patients within 24 hours of presentation
  • What is the feasibility and efficacy of the non-inferiority design [ Time Frame: 4 years ]
    If 10 days of dual anti platelet treatment has equal efficacy in stroke prevention as 30 days of dual anti platelet treatment in patients with recent high risk TIAs


Current Secondary Outcome: To study the incidence of hemorrhagic complications [ Time Frame: 4 years ]

Safety outcome will be the measurement hemorrhagic complication within thirty days of initiation of treatment. To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment


Original Secondary Outcome: To study the incidence of hemorrhagic complications [ Time Frame: 4 years ]

To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment


Information By: University of Alberta

Dates:
Date Received: April 17, 2014
Date Started: July 2014
Date Completion: October 2018
Last Updated: December 28, 2014
Last Verified: December 2014