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Platelet-Inhibitor Drug Trial in Coronary Angioplasty

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 3

Conditions

Myocardial Ischemia
Angina Pectoris
Cardiovascular Diseases
Heart Diseases
Coronary Disease

Treatments

Drug: dipyridamole
Procedure: angioplasty, transluminal, percutaneous coronary
Drug: aspirin

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000510
R01HL031025 (U.S. NIH Grant/Contract)
29

Details and patient eligibility

About

To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.

Full description

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients to age 80 with angina pectoris.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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