Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000510
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Platelet-Inhibitor Drug Trial in Coronary Angioplasty
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 QueryViewReport QVR System
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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL031025 | NIH | None | httpsreporternihgovquickSearchR01HL031025 |