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Sponsored by: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00054938 |
The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus Lupus |
Drug: pravastatin Drug: aspirin Drug: ramipril Drug: Vitamins: B6, B12, and folate Behavioral: heart health educational program |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study |
Estimated Enrollment: | 150 |
Study Start Date: | March 2003 |
Study Completion Date: | December 2005 |
Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
People with SLE are at much higher risk for mortality due to atherosclerotic vascular disease (ASVD). Available data suggest that the usual mechanics of and risk factors for atherosclerosis are enhanced by factors such as corticosteroid use and SLE itself. This study will evaluate a medication and education program designed to prevent ASVD complications (primary prevention) or their recurrence (secondary prevention). The study will also measure the compliance and retention rate for the prevention program over 4 years.
Participants in this study will be randomized to receive either preventive heart disease medications or placebo. Participants in the medication arm will receive pravastatin alone or in combination with the following: aspirin, ramipril, or a combination of vitamins B6, B12, and folate. All participants in this study will receive basic education on how to optimize their heart health. Educational material will be sent to the patients as well as to support persons whom they have named. One group will receive tailored education based on a particular risk factor. Participants will have three study visits and follow-up telephone visits four times a year. Study visits will include a medical history and basic laboratory blood tests. Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure. Participants will be followed for 2 to 4 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Massachusetts | |
Brigham and Women's Hospital, RBB Brigham Arthritis Center | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Matthew H. Liang, MD, MPH | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Matthew H. Liang, MD, MPH ) |
Study ID Numbers: | P60 AR47782 NIAMS-077 |
Study First Received: | February 13, 2003 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00054938 History of Changes |
Health Authority: | United States: Food and Drug Administration |
SLE Accelerated Atherosclerosis Cholesterol |
Antimetabolites Atherosclerosis Arterial Occlusive Diseases Heart Diseases Autoimmune Diseases Antilipemic Agents Lupus Vascular Diseases Anticholesteremic Agents |
Arteriosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors Ramipril Folic Acid Pravastatin Lupus Erythematosus, Systemic Aspirin Vitamins Connective Tissue Diseases |
Atherosclerosis Arterial Occlusive Diseases Antimetabolites Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Antilipemic Agents Vascular Diseases Enzyme Inhibitors |
Arteriosclerosis Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Pravastatin Lupus Erythematosus, Systemic Therapeutic Uses Connective Tissue Diseases Cardiovascular Diseases |