Platelet-Inhibitor Drug Trial in Coronary Angioplasty
Information source: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angina Pectoris; Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia
Intervention: aspirin (Drug); dipyridamole (Drug); angioplasty, transluminal, percutaneous coronary (Procedure)
Phase: Phase 3
Status: Completed
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI) Official(s) and/or principal investigator(s): James Chesebro, Affiliation: Mayo Foundation
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.
Clinical Details
Study design: Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Patients to age 80 with angina pectoris.
Locations and Contacts
Additional Information
Starting date: September 1983
Last updated: November 25, 2013
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