Cardiovascular Diseases Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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