Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol
|ClinicalTrials.gov Identifier: NCT01200836|
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : December 14, 2017
|First Submitted Date||September 10, 2010|
|First Posted Date||September 14, 2010|
|Last Update Posted Date||December 14, 2017|
|Start Date||July 1, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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||Not Provided|
|Change History||Complete list of historical versions of study NCT01200836 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||To describe the effects of statins on platelet activity and coagulation during thrombus formation.|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol|
|Official Title||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 160).
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 Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100165
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 6, 2017|