Recurrent Carotid Stenosis

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ClinicalTrials.gov Identifier: NCT00000527

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : December 11, 2013

Sponsor:

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by:

Emory University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases Carotid Stenosis Cerebrovascular Disorders Heart Diseases Vascular Diseases	Drug: aspirin Drug: dipyridamole	Phase 2

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Prevention
Study Start Date :	August 1986
Actual Primary Completion Date :	November 1998
Actual Study Completion Date :	November 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Dipyridamole

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Men and women who had recently undergone carotid endarterectomy.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Harker LA. Role of platelets and thrombosis in mechanisms of acute occlusion and restenosis after angioplasty. Am J Cardiol. 1987 Jul 31;60(3):20B-28B. Review.

Harker LA: The Use of Agents That Modify Platelet Function in the Management of Thrombotic Disorders. In: Hemostasis and Thrombosis, 2nd Edition, Colman RW et al (eds), Philadelphia, JB Lippincott Co, pp. 1438-1456, 1987.

Scharf RE, Harker LA. Thrombosis and atherosclerosis: regulatory role of interactions among blood components and endothelium. Blut. 1987 Sep;55(3):131-44. Review.

Harker LA, Hanson SR: Antithrombotic Strategies in Peripheral Arterial Disease. In: Vascular Diseases Current Research and Clinical Applications, Strandness DE Jr, et al (eds), Grune & Stratton, Inc., pp. 271-283, 1987.

Harker LA: Antithrombic Therapy in Patients with Transient Ischemic Attacks or Amaurosis Fugax. In: Amaurosis Fugax, Bernstein EF (ed), New York, Springer-Verlag, pp. 110-118, 1988.

Harker LA, Bernstein EF, Dilley RB, Scala TE, Sise MJ, Hye RJ, Otis SM, Roberts RS, Gent M. Failure of aspirin plus dipyridamole to prevent restenosis after carotid endarterectomy. Ann Intern Med. 1992 May 1;116(9):731-6.

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ClinicalTrials.gov Identifier:	NCT00000527 History of Changes
Other Study ID Numbers:	46 R37HL041619 ( U.S. NIH Grant/Contract )
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	December 11, 2013
Last Verified:	December 2013

Additional relevant MeSH terms:

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Cardiovascular Diseases Heart Diseases Constriction, Pathologic Vascular Diseases Carotid Stenosis Cerebrovascular Disorders Pathological Conditions, Anatomical Carotid Artery Diseases Brain Diseases	Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Dipyridamole Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Vasodilator Agents

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