DNA Diagnostic System for Statin Safety and Efficacy (SIM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Genomas, Inc.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hartford Hospital
University of California, San Francisco
Cornell University
Information provided by:
Genomas, Inc
ClinicalTrials.gov Identifier:
NCT00767130
First received: October 2, 2008
Last updated: October 3, 2008
Last verified: October 2008
  Purpose

Lipitor®, Zocor®, and Crestor® are statin drugs commonly taken to lower cholesterol and prevent heart disease. Statins lower cholesterol by different amounts in different patients and sometimes statins cause muscle pain, cramps, or weakness. This study will examine genetic differences in the blood of patients taking statins to predict both how well the statins lower cholesterol, and whether muscle discomfort occurs. Finding such genetic connections is the key to developing genetic tests that might eventually help determine which statin is best for a patient. About 1000 people will be in the study.


Condition
Hypercholesterolemia
Myopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: DNA Diagnostic System for Statin Safety and Efficacy

Resource links provided by NLM:


Further study details as provided by Genomas, Inc:

Primary Outcome Measures:
  • myopathy [ Time Frame: in response to statin therapy ] [ Designated as safety issue: Yes ]
  • serum creatine kinase activity [ Time Frame: in response to statin therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LDL cholesterol [ Time Frame: in response to statin therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA extracted from blood samples


Estimated Enrollment: 750
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
receiving atorvastatin
2
receiving simvastatin
3
receiving rosuvastatin

Detailed Description:

Statin efficacy in primary and secondary prevention of cardiovascular disease has led to increasingly aggressive usage and dosage of statins. Their main clinically relevant safety risk is statin-induced myopathy (SIM) evidenced as a constellation of neuromuscular side effects (NMSE) that include myalgias (muscle aches, cramps, weakness) and myositis (monitored by elevation of serum creatine kinase [CK] activity). NMSEs are disabling to 3-20% of patients on statins, require alteration of therapy, and reduce compliance. NMSEs vary in extent between drugs and from patient to patient. We will develop a novel product termed SIM PhyzioType™ system to provide clinicians with individualized information for each patient on the safest statin drug among atorvastatin, simvastatin, and rosuvastatin, the 3 most prescribed statins. The PhyzioType consists of a multi-SNP (single nucleotide polymorphism) ensemble that, interpreted with a biomathematical algorithm, predicts drug response. We have developed a prototype PhyzioType system incorporating predictive models for myalgia, serum CK activity, and LDLc reduction for atorvastatin and simvastatin patients. We will recruit to obtain 250 patients treated with each drug and use existing clinical records to characterize their NMSE and LDLc responses. We will use physiogenomic analysis to identify those SNPs that differentiate the risk of NMSEs among the 3 statins and combine them into the SIM PhyzioType system. This work will also contribute to the pharmacology of SIM and unravel new pharmaceutical targets. We will create and validate the SIM PhyzioType system with clinically useful prediction of NMSEs and potency for each of the 3 statins. In Phase III a prospective trial is planned for FDA approval of the SIM PhyzioType product.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients treated for hypercholesterolemia at Hartford Hospital, University of California-San Francisco, or the Rogosin Clinic at New York Presbyterian Hospital

Criteria

Inclusion Criteria:

  • receiving, or documented to have received in the past, any of the statins including atorvastatin, simvastatin, rosuvastatin treatment for hypercholesterolemia
  • chart-documented clinical record of having had, never having had, or possibly having had, statin-associated myopathy

Exclusion Criteria:

  • never having taken any statin medication
  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: NCT00767130

Contacts
Contact: Richard L. Seip, PhD 860-545-5005 rseip@harthosp.org

Locations
United States, California
University of California-San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Alan H.B. Wu, PhD    (415) 206-3540    wualan@labmed2.ucsf.edu   
Principal Investigator: Alan H.B. Wu, PhD         
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Richard L. Seip, PhD    860-545-5005    rseip@harthosp.org   
Principal Investigator: Paul D. Thompson, M.D.         
United States, New York
Rogosin Institute, New York Presbyterian Hospital Recruiting
New York, New York, United States, 10021
Contact: Chioma Okoro    212-702-9600 ext 105    cokoro@mail.rockefeller.edu   
Contact: Bruce Gordon, M.D.         
Principal Investigator: Bruce Gordon, M.D.         
Sponsors and Collaborators
Genomas, Inc
Hartford Hospital
University of California, San Francisco
Cornell University
Investigators
Principal Investigator: Gualberto Ruano, MD, PhD Genomas, Inc
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gualberto Ruano/President, Genomas, Inc.
ClinicalTrials.gov Identifier: NCT00767130     History of Changes
Other Study ID Numbers: 1 R44 HL091697-01
Study First Received: October 2, 2008
Last Updated: October 3, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Genomas, Inc:
single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin

Additional relevant MeSH terms:
Hypercholesterolemia
Muscular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 21, 2014