Completed

Platelet-Inhibitor Drug Trial in Coronary Angioplasty

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What is being tested

aspirin

+ dipyridamole

+ angioplasty, transluminal, percutaneous coronary

DrugProcedure
Who is being recruted

Chest Pain+8

+ Neurologic Manifestations

+ Pain

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: September 1983
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1983

Actual date on which the first participant was enrolled.

BACKGROUND: By dilating coronary stenoses, PTCA can relieve angina pectoris and improve exercise tolerance and left ventricular function. However, restenosis occurs in 20-30 percent of dilated stenoses within three to six months following PTCA making it necessary to restrict patient activities, resume antianginal medications, repeat PTCA, or perform coronary artery bypass surgery. Balloon dilatation of the atherosclerotic lesion damages the endothelium, intima, and media of the artery. This may lead to restenosis via platelet deposition, mural thrombus formation, and intimal proliferation by mechanisms that appear similar to those causing aortocoronary vein graft (ACVG) occlusions. It had been demonstrated that dipyridamole plus aspirin therapy suppressed these mechanisms of ACVG occlusion in the animal model, prolonged a shortened platelet survival in patients with coronary artery disease, and reduced ACVG occlusions in patients both early and late after the operation. Thus, a trial of these drugs in patients undergoing PTCA was a logical and necessary step to reduce the major shortcoming of the initially successful PTCA therapy, namely the high rate of restenosis. DESIGN NARRATIVE: Randomized, double-blind, fixed sample. Patients were randomized to treatment with dipyridamole plus aspirin or placebo. The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

NCT00000510
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chest PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesAngina PectorisCardiovascular DiseasesCoronary DiseaseHeart DiseasesMyocardial Ischemia

Criteria

Patients to age 80 with angina pectoris.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers