Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000599
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
1999-10-27
Brief Title:
Cholesterol-Lowering Atherosclerosis Study CLAS
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:
2000-05
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 combined therapy with the lipid lowering agents colestipol hydrochloride plus niacin would produce significant change in coronary carotid and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography Also to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral coronary and carotid arteries
Detailed Description:
BACKGROUND
The Lipid Research Clinics Coronary Primary Prevention Trial and the Coronary Drug Project had shown that morbidity and mortality from ischemic heart disease were reduced by blood cholesterol-lowering therapy Although blood cholesterol reduction ameliorated experimental atherosclerosis in animal models the two largest human studies with angiographic observation of arterial lesion change the NHLBI Type II Coronary Intervention Study and a study by Cohn et al had not demonstrated significant treatment effects Favorable but inconclusive treatment trends were observed in four unrandomized angiographic trials and one trial too small for evaluation of randomized groups
The clinical trial was supported by a subproject within a program project grant
DESIGN NARRATIVE
CLAS-I was randomized and selectively-blinded Screening for the trial consisted of five clinic visits at which baseline data including angiographic data were obtained and a prerandomization trial of the study drugs was conducted One hundred eighty-eighty subjects were randomized to either 30 grams g of colestipol hydrochloride plus 3 to 12 g of niacin daily or to placebo Both groups received diet intervention The drug group received less than 125 milligrams mg of cholesterol daily 22 percent of energy as fat 10 percent as polyunsaturated fat and 4 percent as saturated fat The placebo group received less than 250 mg of cholesterol per day 26 percent of energy as fat 10 percent as polyunsaturated fat and 5 percent as saturated fat The different diet composition for drug and placebo groups was to enhance the differential in blood cholesterol responses between the two groups Study subjects and clinic staff were blinded to the prerandomization study drug trial lipid responses Subjects were blinded to treatment assignments Subjects and staff were not blinded to on-trial lipid values The primary endpoint the global change score was change in atherosclerosis observed by angiography of native coronary arteries and aorta coronary bypass grafts Evaluation of study end-points was performed by staff and consultants who were blinded to treatment group assignments as well as to the temporal ordering of angiographic data Subjects were seen monthly for the first six months and then at two-month intervals A repeat angiogram was performed at two years Of the 188 randomized subjects 162 completed the study
On completion of CLAS-I participants not requiring further bypass surgery were invited to continue in CLAS-II for an additional two years on their previously assigned treatment Blinded study methods were maintained there was no crossover between treatments One hundred thirty-eight subjects continued in CLAS-II 103 completed a third angiogram before the CLAS-I outcome was known and CLAS-II terminated The CLAS-II clinical procedures lipid lipoprotein-cholesterol and apolipoprotein analyses were the same as in CLAS-I The CLAS-II angiographic and file evaluation procedures exactly replicated those in CLAS-I
The study completion date listed in this record was obtained from the QueryViewReport QVR System
The Lipid Research Clinics Coronary Primary Prevention Trial and the Coronary Drug Project had shown that morbidity and mortality from ischemic heart disease were reduced by blood cholesterol-lowering therapy Although blood cholesterol reduction ameliorated experimental atherosclerosis in animal models the two largest human studies with angiographic observation of arterial lesion change the NHLBI Type II Coronary Intervention Study and a study by Cohn et al had not demonstrated significant treatment effects Favorable but inconclusive treatment trends were observed in four unrandomized angiographic trials and one trial too small for evaluation of randomized groups
The clinical trial was supported by a subproject within a program project grant
DESIGN NARRATIVE
CLAS-I was randomized and selectively-blinded Screening for the trial consisted of five clinic visits at which baseline data including angiographic data were obtained and a prerandomization trial of the study drugs was conducted One hundred eighty-eighty subjects were randomized to either 30 grams g of colestipol hydrochloride plus 3 to 12 g of niacin daily or to placebo Both groups received diet intervention The drug group received less than 125 milligrams mg of cholesterol daily 22 percent of energy as fat 10 percent as polyunsaturated fat and 4 percent as saturated fat The placebo group received less than 250 mg of cholesterol per day 26 percent of energy as fat 10 percent as polyunsaturated fat and 5 percent as saturated fat The different diet composition for drug and placebo groups was to enhance the differential in blood cholesterol responses between the two groups Study subjects and clinic staff were blinded to the prerandomization study drug trial lipid responses Subjects were blinded to treatment assignments Subjects and staff were not blinded to on-trial lipid values The primary endpoint the global change score was change in atherosclerosis observed by angiography of native coronary arteries and aorta coronary bypass grafts Evaluation of study end-points was performed by staff and consultants who were blinded to treatment group assignments as well as to the temporal ordering of angiographic data Subjects were seen monthly for the first six months and then at two-month intervals A repeat angiogram was performed at two years Of the 188 randomized subjects 162 completed the study
On completion of CLAS-I participants not requiring further bypass surgery were invited to continue in CLAS-II for an additional two years on their previously assigned treatment Blinded study methods were maintained there was no crossover between treatments One hundred thirty-eight subjects continued in CLAS-II 103 completed a third angiogram before the CLAS-I outcome was known and CLAS-II terminated The CLAS-II clinical procedures lipid lipoprotein-cholesterol and apolipoprotein analyses were the same as in CLAS-I The CLAS-II angiographic and file evaluation procedures exactly replicated those in CLAS-I
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 |
|---|---|---|---|
| P01HL023619 | NIH | None | httpsreporternihgovquickSearchP01HL023619 |