Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000496
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Platelet Drug Trial in Coronary Disease Progression
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:
2012-04
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 the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications
Detailed Description:
BACKGROUND
Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction especially in those patients who enter the hospital early its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital When the trial was initiated in 1979 new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy
DESIGN NARRATIVE
Randomized double-blind The patients in the experimental group were treated with dipyridamole and aspirin for five years Patients in the control group received a lactose placebo The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease Secondary endpoints included total mortality cardiac mortality mortality due to myocardial infarction and incidence of new myocardial infarction Recruitment ended in December 1982
The study completion date listed in this record was obtained from the statement immediately above Recruitment ended in December 1982 and was confirmed from the QueryViewReport QVR System
Coronary atherosclerosis is the leading cause of death in this country and the developed countries of the world Although modern coronary care units have resulted in a markedly decreased hospital mortality from acute myocardial infarction especially in those patients who enter the hospital early its overall impact is limited since two-thirds of patients who die from coronary disease do not reach the hospital When the trial was initiated in 1979 new approaches to the medical treatment of coronary disease and its complications were needed with an effort directed towards prevention of its progression and prevention of its complications through medical therapy This prevention could save significant health care dollars over the long-term especially if the need for aortocoronary bypass graft surgery and the incidence of myocardial infarction could be reduced Early identification of the patient at risk of developing coronary disease or of those with early coronary artery lesions would allow a greater impact of any successful intervention therapy
DESIGN NARRATIVE
Randomized double-blind The patients in the experimental group were treated with dipyridamole and aspirin for five years Patients in the control group received a lactose placebo The primary endpoint was angiographic evidence of progression of coronary artery disease and development of new coronary disease Secondary endpoints included total mortality cardiac mortality mortality due to myocardial infarction and incidence of new myocardial infarction Recruitment ended in December 1982
The study completion date listed in this record was obtained from the statement immediately above Recruitment ended in December 1982 and was confirmed 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?: