| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT00000510 |
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 III |
| MedlinePlus related topics: | Angina Angioplasty Blood Thinners Heart Diseases |
| Drug Information available for: | Acetylsalicylic acid Dipyridamole |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind |
| Study Start Date: | September 1983 |
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.
Eligibility
| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Patients to age 80 with angina pectoris.
Contacts and Locations More Information
| Study ID Numbers: | 29 |
| First Received: | October 27, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000510 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
