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
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Patients aged 65 or less. Angiographically identified coronary heart disease
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000496
First Posted
October 27, 1999
Last Updated
November 25, 2013
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
Learn more about this trial
Platelet Drug Trial in Coronary Disease Progression
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