Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000553
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
1999-10-27
Brief Title:
HDL-Atherosclerosis Treatment Study HATS
Sponsor:
University of Washington
Organization:
University of Washington
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 measure the effects of lipid-lowering drugs andor antioxidant vitamins on progression or regression of coronary heart disease as measured by quantitative angiography in patients with low high density lipoprotein HDL cholesterol
Detailed Description:
BACKGROUND
More than one-third of patients with coronary disease have low high density lipoprotein cholesterol HDLc levels less than 35 mgdl United States 20th percentile and normal low density lipoprotein cholesterol LDLc less than 145 United States mean a group for whom current treatment guidelines are not based on clinical trial data Low HDLc levels are strong independent predictors of cardiovascular disease and cardiovascular mortality risk equally so for both men and women This high coronary artery disease risk may be due to an imbalance between delivery of cholesterol into the arterial intima by LDL and its removal by HDL Also since HDL serve as antioxidants and cytoprotectants an important HDL role may be to prevent LDL oxidation and thus limit macrophage-mediated intimal lipid accumulation or to prevent vascular cell toxicity Recent epidemiologic experimental and clinical trial evidence suggests that a 15 mgdl rise in HDL cholesterol would reduce coronary artery disease incidence and mortality by 30 to 70 percent and that antioxidant vitamins E C and beta-carotene might reduce coronary artery disease events and atherogenesis The potential absolute benefit is much greater in those with existing coronary artery disease It has also been shown that HDLc rises in response to exercise smoking cessation weight reduction and monounsaturated fats
DESIGN NARRATIVE
Randomized Phase III Each patient was randomly assigned to a lipid-altering strategy or its placebo and to an antioxidant vitamin strategy or its placebo in a 2 x 2 factorial design The four groups were simvastatin-niacin plus an antioxidant vitamin cocktail simvastatin-niacin plus vitamin placebo antioxidant vitamins alone plus simvastatin-niacin placebo or placebos for both strategies All groups were counseled with respect to diet exercise and smoking cessation The primary endpoint was the average change in proximal obstructive disease during the 25 year interval between baseline and the followup study Secondary endpoints included the frequency of cardiac events including cardiac death confirmed non-fatal myocardial infarction cerebrovascular accident or revascularization by bypass or angioplasty for medically refractory unstable ischemia The trial ended in August 1999
More than one-third of patients with coronary disease have low high density lipoprotein cholesterol HDLc levels less than 35 mgdl United States 20th percentile and normal low density lipoprotein cholesterol LDLc less than 145 United States mean a group for whom current treatment guidelines are not based on clinical trial data Low HDLc levels are strong independent predictors of cardiovascular disease and cardiovascular mortality risk equally so for both men and women This high coronary artery disease risk may be due to an imbalance between delivery of cholesterol into the arterial intima by LDL and its removal by HDL Also since HDL serve as antioxidants and cytoprotectants an important HDL role may be to prevent LDL oxidation and thus limit macrophage-mediated intimal lipid accumulation or to prevent vascular cell toxicity Recent epidemiologic experimental and clinical trial evidence suggests that a 15 mgdl rise in HDL cholesterol would reduce coronary artery disease incidence and mortality by 30 to 70 percent and that antioxidant vitamins E C and beta-carotene might reduce coronary artery disease events and atherogenesis The potential absolute benefit is much greater in those with existing coronary artery disease It has also been shown that HDLc rises in response to exercise smoking cessation weight reduction and monounsaturated fats
DESIGN NARRATIVE
Randomized Phase III Each patient was randomly assigned to a lipid-altering strategy or its placebo and to an antioxidant vitamin strategy or its placebo in a 2 x 2 factorial design The four groups were simvastatin-niacin plus an antioxidant vitamin cocktail simvastatin-niacin plus vitamin placebo antioxidant vitamins alone plus simvastatin-niacin placebo or placebos for both strategies All groups were counseled with respect to diet exercise and smoking cessation The primary endpoint was the average change in proximal obstructive disease during the 25 year interval between baseline and the followup study Secondary endpoints included the frequency of cardiac events including cardiac death confirmed non-fatal myocardial infarction cerebrovascular accident or revascularization by bypass or angioplasty for medically refractory unstable ischemia The trial ended in August 1999
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 |
|---|---|---|---|
| R01HL049546 | NIH | None | httpsreporternihgovquickSearchR01HL049546 |