Recurrent Carotid Stenosis

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000527
• Other study ID #: 46
• Secondary ID: R37HL041619
• Status: Completed
• Phase: Phase 2
• First received: October 27, 1999
• Last updated: December 9, 2013
• Start date: August 1986
• Est. completion date: November 1998

Study information

• Verified date: December 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 1998
• Est. primary completion date: November 1998
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years
• Eligibility: Men and women who had recently undergone carotid endarterectomy.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Carotid Stenosis
• Cerebrovascular Disorders
• Heart Diseases
• Vascular Diseases

Intervention

Drug:
• aspirin

• dipyridamole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (6)

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. — View Citation

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. 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. — View Citation

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: 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. — View Citation