Early Atherosclerosis Change in Two Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005696
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : February 29, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To complete end point analysis for the Monitored Atherosclerosis Regression Study (MARS) and to compare coronary versus carotid treatment effect relationships in MARS to coronary versus carotid treatment effect relationships in the Cholesterol Lowering Atherosclerosis Study (CLAS). Both MARS and CLAS were serial arterial imaging trials that explored the reversibility of atherosclerosis with lipid-lowering therapy in native coronary, carotid, and femoral arterial beds, as well as in coronary artery bypass grafts.

Condition or disease
Cardiovascular Diseases Heart Diseases Carotid Artery Diseases Coronary Disease Atherosclerosis

Detailed Description:


MARS was a randomized, double-blind, placebo-controlled, angiographic trial comparing the effects of lipid lowering by lovastatin and diet with diet plus placebo in 270 subjects. The target study population consisted of males and females under 70 years of age with cholesterol levels from 200 to 295 mg/dL and coronary artery disease in two or more coronary artery segments. Follow-up coronary angiograms were performed two and four years post-randomization in 247 and 68 subjects, respectively; providing information on atherosclerosis regression/progression of coronary artery intrusive lesions. Carotid ultrasound images have been recorded at four month intervals for periods up to four years in 215 subjects providing information on atherosclerosis regression/progression of pre-intrusive (intima-media thickness) lesions in parallel with coronary artery intrusive lesions. Unique features of MARS included: 1) Simultaneous coronary angiography (evaluated both by quantitative coronary angiography (QCA) and panel-reading) and carotid ultrasonography in a cohort of over 200 subjects; 2) The opportunity to evaluate the largest lipoprotein and apolipoprotein data collected in an angiographic trial to date. This included extensive VLDL, LDL, IDL, and HDL subclasses as well as LDL type pattern, lipoprotein particles and apolipoprotein (including AI, B, CIII, and E); and, 3) The opportunity to evaluate dietary effects on atherosclerosis regression/progression only in one other angiographic trail, CLAS.

The Cholesterol Lowering Atherosclerosis Study (CLAS) was a randomized angiographic trial comparing combined colestipol/niacin therapy with placebo in 162 subjects. A unique feature of MARS and CLAS has shown a similar effect in CLAS-like men (non-smoking men with CABG) and women. Since carotid intima-media thickness, QCA, and global change score have been shown to be predictive of clinical coronary events, understanding the relationship between these atherosclerotic measures may be important in establishing carotid intima-media thickness measurements as a proxy measure for coronary atherosclerosis.


Collected data for both trials were analyzed and compared to evaluate effects of treatment on carotid and coronary artery atherosclerotic lesions. Coronary angiograms and carotid ultrasound imaging were performed under identical conditions in both trials. Five major databases were available for analysis, including: the coronary artery database (QCA processed); the carotid artery database (ultrasound evaluation); the coronary artery database (panel evaluation); the nutrient content database, and the clinical and biochemical database. Major comparisons included measurements of atherosclerotic lesions in both arteries, the effects of lipid, lipoprotein, and apolipoprotein levels on vascular lesions, and the effect of nutrient intake (in particular total fat, saturated fat, and cholesterol) on rates of measured lesion change. Additional associations were sought between preintrusive carotid lesions and intrusive coronary lesions between males and females, smokers and nonsmokers, differences in age, and differential drug effect on HDL-cholesterol.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Study Type : Observational
Time Perspective: Retrospective
Study Start Date : January 1994
Actual Study Completion Date : December 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005696

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Howard Hodis University of Southern California

Publications: Identifier: NCT00005696     History of Changes
Other Study ID Numbers: 4263
R01HL049885 ( U.S. NIH Grant/Contract )
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: February 29, 2016
Last Verified: May 2005

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Coronary Artery Disease
Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Myocardial Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases