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Platelet-Inhibitor Drug Trial in Coronary Angioplasty

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ClinicalTrials.gov Identifier: NCT00000510
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : November 26, 2013
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Study Start Date : September 1983
Actual Study Completion Date : September 1988

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients to age 80 with angina pectoris.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000510


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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OverallOfficial: James Chesebro Mayo Foundation
More Information
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ClinicalTrials.gov Identifier: NCT00000510     History of Changes
Other Study ID Numbers: 29
R01HL031025 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: November 26, 2013
Last Verified: March 2005
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Myocardial Ischemia
Angina Pectoris
Ischemia
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases
Chest Pain
 Pain
Neurologic Manifestations
Signs and Symptoms
Dipyridamole
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents