Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
|First Received Date ICMJE||September 10, 2010|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||June 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01200836 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To describe the effects of statins on platelet activity and coagulation during thrombus formation.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol|
|Official Title ICMJE||Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol|
- 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 130).
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 ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Healthy Volunteers|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||30|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01200836|
|Other Study ID Numbers ICMJE||100165, 10-H-0165|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP