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CompletedNCT00000496Updated Nov 26, 2013

Platelet Drug Trial in Coronary Disease Progression

A Phase 3 interventional study of aspirin and dipyridamole in Cardiovascular Diseases, Coronary Disease and Heart Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
  • Myocardial Ischemia
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

Browse Cardiovascular Diseases studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Patients aged 65 or less. Angiographically identified coronary heart disease

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Masking
Double

Interventions

  • Drugaspirin
  • Drugdipyridamole
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00000496
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
Oct 28, 1999
Start date
Dec 1979
Completion
Dec 1982
Last update
Nov 26, 2013
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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