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Platelet Drug Trial in Coronary Disease Progression

Primary Purpose

Cardiovascular Diseases, Coronary Disease, Heart Diseases

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
aspirin
dipyridamole
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Patients aged 65 or less. Angiographically identified coronary heart disease

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    November 25, 2013
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000496
    Brief Title
    Platelet Drug Trial in Coronary Disease Progression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1979 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 1982 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.
    Detailed Description
    BACKGROUND: Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world. Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction, especially in those patients who enter the hospital early, its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital. When the trial was initiated in 1979, new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy. This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced. Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy. DESIGN NARRATIVE: Randomized, double-blind. The patients in the experimental group were treated with dipyridamole and aspirin for five years. Patients in the control group received a lactose placebo. The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease. Secondary endpoints included total mortality, cardiac mortality, mortality due to myocardial infarction, and incidence of new myocardial infarction. Recruitment ended in December 1982. The study completion date listed in this record was obtained from the statement immediately above ("Recruitment ended in December 1982") and was confirmed from the Query/View/Report (QVR) System.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    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
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Patients aged 65 or less. Angiographically identified coronary heart disease

    12. IPD Sharing Statement

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    Platelet Drug Trial in Coronary Disease Progression

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