Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
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|ClinicalTrials.gov Identifier: NCT01200836|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : March 29, 2018
- The drug rosuvastatin (also called Crestor) is used to lower cholesterol levels in people with elevated cholesterol levels. Recent studies have suggested that rosuvastatin may affect the immune system and reduce inflammation, but the reason for this effect is unclear. Researchers are interested in testing the effect of rosuvastatin on the immune systems of healthy volunteers with good cholesterol levels.
- To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.
- Healthy individuals at least 18 years of age who have an acceptable blood level of LDL cholesterol (below 160).
- Participants will be screened with a medical history and physical examination, as well as blood tests to check general health, cholesterol levels, liver function, and the C-reactive protein (which responds to inflammation).
- Participants will not be permitted to take most prescription and over-the-counter medications that affect the immune system, including antihistamines and certain pain relievers. For 1 week before the study, participants will have a wash-out period without any of these medications.
- Participants will take rosuvastatin daily for 4 weeks, always in the evening (to ensure consistent blood sample results).
- Participants will provide blood samples at the following time points: (1) immediately before the start of the rosuvastatin treatment, (2) after 2 weeks of treatment, (3) after 4 weeks of treatment, and (4) 2 weeks after the end of treatment.
|Condition or disease|
Statins are drugs that inhibit cholesterol synthesis and are used extensively for primary and secondary prevention of heart disease. Their benefit to patients with heart diseases appears to exceed that predicted from cholesterol lowering alone. A recent study has found benefits of statin therapy in patients with normal cholesterol and high C-reactive protein, a marker of inflammation, suggesting that statins exert an anti inflammatory effect in addition to the well known cholesterol lowering activity. Studies in mice have revealed mixed observations regarding the role of statins in inflammation. Therefore the Center for Human Immunology, Autoimmunity and Inflammation is conducting this trial to study the effects of statins on the immune system and the inflammatory response in healthy volunteers with normal cholesterol levels, and normal or elevated C-reactive protein levels.
The primary objective is to characterize the immune system before and during statin therapy.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol|
|Study Start Date :||July 1, 2010|
- To elucidate the effects of a four week course of statins on the immune system in healthy volunteers with normal cholesterol with or without elevated C-reactive protein.
- To describe the effects of statins on platelet activity and coagulation during thrombus formation.
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 ClinicalTrials.gov identifier (NCT number): NCT01200836
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Angelique Biancotto, Ph.D.||National Institute of Allergy and Infectious Diseases (NIAID)|