Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000594
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
1999-10-27
Brief Title:
NHLBI Type II Coronary Intervention Study
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 whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression a regression of coronary artery disease as demonstrated by death myocardial infarction or progression of disease on angiography
Detailed Description:
BACKGROUND
There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction The study should be contrasted with the Coronary Primary Prevention Trial CPPT which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality It should be noted that patients in the CPPT did not have known preexisting coronary heart disease
DESIGN NARRATIVE
A randomized double-blind trial with single experimental and control groups The experimental group received drug therapy cholestyramine the control group received placebo Both groups received diet therapy The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death Patients were followed under therapy for at least 5 years
There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction The study should be contrasted with the Coronary Primary Prevention Trial CPPT which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality It should be noted that patients in the CPPT did not have known preexisting coronary heart disease
DESIGN NARRATIVE
A randomized double-blind trial with single experimental and control groups The experimental group received drug therapy cholestyramine the control group received placebo Both groups received diet therapy The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death Patients were followed under therapy for at least 5 years
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?: