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Platelet-Inhibitor Drug Trial in Coronary Angioplasty

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000510
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
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 Intervention Phase
Angina Pectoris Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Drug: aspirin Drug: dipyridamole Procedure: angioplasty, transluminal, percutaneous coronary Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1983
Study Completion Date: September 1988
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Patients to age 80 with angina pectoris.
  Contacts and Locations
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
OverallOfficial: James Chesebro Mayo Foundation
  More Information

ClinicalTrials.gov Identifier: NCT00000510     History of Changes
Other Study ID Numbers: 29
R01HL031025 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: November 26, 2013
Last Verified: March 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Angina Pectoris
Pathologic Processes
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents