Recurrent Carotid Stenosis

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Emory University

Status and phase

Completed
Phase 2

Conditions

Carotid Stenosis
Cardiovascular Diseases
Vascular Diseases
Heart Diseases
Cerebrovascular Disorders

Treatments

Drug: aspirin
Drug: dipyridamole

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00000527
R37HL041619 (U.S. NIH Grant/Contract)
46

Details and patient eligibility

About

To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.

Full 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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Men and women who had recently undergone carotid endarterectomy.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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