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Recurrent Carotid Stenosis

Primary Purpose

Cardiovascular Diseases, Carotid Stenosis, Cerebrovascular Disorders

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
aspirin
dipyridamole
Sponsored by
Emory University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men and women who had recently undergone carotid endarterectomy.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    December 9, 2013
    Sponsor
    Emory University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000527
    Brief Title
    Recurrent Carotid Stenosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1986 (undefined)
    Primary Completion Date
    November 1998 (Actual)
    Study Completion Date
    November 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Emory University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Carotid Stenosis, Cerebrovascular Disorders, Heart Diseases, Vascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    aspirin
    Intervention Type
    Drug
    Intervention Name(s)
    dipyridamole

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women who had recently undergone carotid endarterectomy.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2956836
    Citation
    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. doi: 10.1016/0002-9149(87)90479-6.
    Results Reference
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    Citation
    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.
    Results Reference
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    PubMed Identifier
    3304475
    Citation
    Scharf RE, Harker LA. Thrombosis and atherosclerosis: regulatory role of interactions among blood components and endothelium. Blut. 1987 Sep;55(3):131-44. doi: 10.1007/BF00320567.
    Results Reference
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    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.
    Results Reference
    background
    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.
    Results Reference
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    PubMed Identifier
    1558344
    Citation
    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. doi: 10.7326/0003-4819-116-9-731.
    Results Reference
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    Recurrent Carotid Stenosis

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