Platelet-Inhibitor Drug Trial in Coronary Angioplasty

Sponsor

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000510

Collaborator

(none)

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia	Drug: aspirin Drug: dipyridamole Procedure: angioplasty, transluminal, percutaneous coronary	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Prevention

Study Start Date :

Sep 1, 1983

Actual Study Completion Date :

Sep 1, 1988

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Patients to age 80 with angina pectoris.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

: James Chesebro, Mayo Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00000510

Other Study ID Numbers:

29
R01HL031025

First Posted:

Oct 28, 1999

Last Update Posted:

Nov 26, 2013

Last Verified:

Mar 1, 2005

Additional relevant MeSH terms:

Cardiovascular Diseases

Study Results

No Results Posted as of Nov 26, 2013