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

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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 |

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
OverallOfficial: | James Chesebro | Mayo Foundation |
ClinicalTrials.gov Identifier: | NCT00000510 |
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 |
Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Ischemia Angina Pectoris Ischemia Pathologic Processes Vascular Diseases Chest Pain Pain Neurologic Manifestations Aspirin Dipyridamole Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Phosphodiesterase Inhibitors Vasodilator Agents |