Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01200836
First received: September 10, 2010
Last updated: August 15, 2014
Last verified: February 2014
  Purpose

Background:

- 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.

Objectives:

- To evaluate the effect of rosuvastatin on the immune systems of healthy volunteers.

Eligibility:

- Healthy individuals at least 18 years of age who have an acceptable blood level of LDL cholesterol (below 130).

Design:

  • 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 Phase
Healthy Volunteers
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Rosuvastatin on the Immune System in Healthy Volunteers With Normal Cholesterol

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

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.

Secondary Outcome Measures:
  • To describe the effects of statins on platelet activity and coagulation during thrombus formation.

Estimated Enrollment: 30
Study Start Date: June 2010
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:
  • Healthy volunteer (health status confirmed by brief History and Physical Exam and routine blood work as determined by the screening protocol)
  • Age greater than or equal to18 years of age
  • LDL < 130 mg/dL
  • Ten subjects must have hsCRP < 2mg/L, and ten subjects must have hsCRP greater than or equal to 2 mg/L

EXCLUSION CRITERIA:

  • Female subjects may not be pregnant or lactating due to minor side effects of use of statins in a non-benefit study.
  • Abnormal LFT s, i.e. AST > 34 U/L; ALT > 41 U/L; T. Bilirubin > 1.0 mg/dL; Alkaline Phosphatasse > 116 U/L.
  • Other contraindication to statins (i.e. inadequately treated hypothyroidism, renal impairment, liver disease, elevated transaminases, diabetes mellitus or hypersensitivity to a statin)
  • Subjects unable to comprehend the investigational nature of the procedure or unable or unwilling to sign the consent.
  • Statin usage within the last six months prior to enrollment.
  • Subjects not willing to participate in the gene expression analysis and whole genome expression and polymorphisms studies portion of this protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200836

Contacts
Contact: Kinneret S Broder (301) 402-2837 broderk@mail.nih.gov
Contact: Shira Y Perl, M.D. (301) 594-0512 perls@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Shira Y Perl, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01200836     History of Changes
Other Study ID Numbers: 100165, 10-H-0165
Study First Received: September 10, 2010
Last Updated: August 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Statins
Immune Modulation
Healthy Volunteer

Additional relevant MeSH terms:
Rosuvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014