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Trial NCT00000527

Resource URI: http://static.linkedct.org/resource/trials/NCT00000527
PropertyValue
linkedct:brief_title Recurrent Carotid Stenosis
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/2348>
linkedct:condition <http://static.linkedct.org/resource/condition/2475>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:criteria Men and women who had recently undergone carotid endarterectomy.
linkedct:description BACKGROUND: 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. DESIGN NARRATIVE: 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 75 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000527
rdfs:label Trial NCT00000527
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000527
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 46
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000527>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/1552>
linkedct:reference <http://static.linkedct.org/resource/reference/1553>
linkedct:reference <http://static.linkedct.org/resource/reference/1554>
linkedct:reference <http://static.linkedct.org/resource/reference/24817>
linkedct:reference <http://static.linkedct.org/resource/reference/40139>
linkedct:reference <http://static.linkedct.org/resource/reference/40737>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1986
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.
rdf:type linkedct:trials
linkedct:verification_date January 2000