Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000512
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
1999-10-27
Brief Title:
Familial Atherosclerosis Treatment Study
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Familial Atherosclerosis Treatment Study
Status:
COMPLETED
Status Verified Date:
2015-12
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:
FATS
Brief Summary:
To compare the effects of two intensive lipid-lowering regimens with conventional therapy on coronary atherosclerosis as assessed by arteriography
Detailed Description:
BACKGROUND
For several decades clinical trials have addressed the question of whether treatment of hyperlipidemia reduces the risk of cardiovascular events Substantial evidence supports the idea that cardiovascular benefits are related to the degree of reduction in low-density lipoprotein cholesterol level and perhaps to the degree of increase in the high-density lipoprotein cholesterol level In these trials changes in lipid levels have usually been small and the overall clinical benefits have been limited The appearance in the 1980s of more effective treatments for hyperlipidemia new arteriographic methods for assessing atherosclerosis and new insights into atherogenesis permitted an objective investigation into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering agents
The clinical trial was supported by a subproject within a program project grant
DESIGN NARRATIVE
Randomized double-blind placebo-controlled Baseline arteriograms were performed and fasting lipid samples drawn before heparinization Patients were stratified for age below 45 years cigarette smoking within the previous month and lipid patterns including familial hypercholesterolemia and triglyceride levels Patients were given dietary counseling and randomly assigned to one of three treatments lovastatin 20 mg twice a day and colestipol 10 g three times a day niacin 1 g four times a day and colestipol 10 g three times a day or conventional therapy with placebo or colestipol if the LDL cholesterol level was elevated The primary endpoint was a measure of change in the severity of disease in the proximal coronary arteries as measured by quantitative arteriography
For several decades clinical trials have addressed the question of whether treatment of hyperlipidemia reduces the risk of cardiovascular events Substantial evidence supports the idea that cardiovascular benefits are related to the degree of reduction in low-density lipoprotein cholesterol level and perhaps to the degree of increase in the high-density lipoprotein cholesterol level In these trials changes in lipid levels have usually been small and the overall clinical benefits have been limited The appearance in the 1980s of more effective treatments for hyperlipidemia new arteriographic methods for assessing atherosclerosis and new insights into atherogenesis permitted an objective investigation into whether the progression of atherosclerosis was retarded or reversed by lipid-lowering agents
The clinical trial was supported by a subproject within a program project grant
DESIGN NARRATIVE
Randomized double-blind placebo-controlled Baseline arteriograms were performed and fasting lipid samples drawn before heparinization Patients were stratified for age below 45 years cigarette smoking within the previous month and lipid patterns including familial hypercholesterolemia and triglyceride levels Patients were given dietary counseling and randomly assigned to one of three treatments lovastatin 20 mg twice a day and colestipol 10 g three times a day niacin 1 g four times a day and colestipol 10 g three times a day or conventional therapy with placebo or colestipol if the LDL cholesterol level was elevated The primary endpoint was a measure of change in the severity of disease in the proximal coronary arteries as measured by quantitative arteriography
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL030086 | NIH | None | httpsreporternihgovquickSearchP01HL030086 |