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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

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 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

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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.

Publications:
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.
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.

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:
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