Recurrent Carotid Stenosis
|Cardiovascular Diseases Carotid Stenosis Cerebrovascular Disorders Heart Diseases Vascular Diseases||Drug: aspirin Drug: dipyridamole||Phase 2|
|Study Design:||Allocation: Randomized
Primary Purpose: Prevention
|Study Start Date:||August 1986|
|Study Completion Date:||November 1998|
|Primary Completion Date:||November 1998 (Final data collection date for primary outcome measure)|
Following endarterectomy, platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis. Many patients had been treated with aspirin and dipyridamole, but not in a controlled trial. The Recurrent Carotid Stenosis Study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis.
Randomized, double-blind. Eighty-three patients (90 endarterectomies) were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole, beginning 12 hours pre-operatively, followed by a second dose administered within eight hours after the operation, and given three times daily thereafter for one year. Eighty patients (85 endarterectomies) received placebo. After the adequacy of the surgical procedure was confirmed by intraoperative angiography, restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year.