MedDataX Logo

DNA Diagnostic System for Statin Safety and Efficacy

NCT ID: NCT00767130

Last Updated: 2008-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia Myopathy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

single nucleotide polymorphisms, SNP, LDL cholesterol, statin myopathy, atorvastatin, simvastatin, rosuvastatin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

receiving atorvastatin

No interventions assigned to this group

2

receiving simvastatin

No interventions assigned to this group

3

receiving rosuvastatin

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hartford Hospital

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Cornell University

OTHER

Sponsor Role collaborator

Genomas, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Genomas, Inc.

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gualberto Ruano, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Genomas, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California-San Francisco

San Francisco, California, United States

Site Status RECRUITING

Hartford Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Rogosin Institute, New York Presbyterian Hospital

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Richard L. Seip, PhD

Role: CONTACT

Phone: 860-545-5005

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Alan H.B. Wu, PhD

Role: primary

Richard L. Seip, PhD

Role: primary

Chioma Okoro

Role: primary

Bruce Gordon, M.D.

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Ruano G, Thompson PD, Windemuth A, Seip RL, Dande A, Sorokin A, Kocherla M, Smith A, Holford TR, Wu AH. Physiogenomic association of statin-related myalgia to serotonin receptors. Muscle Nerve. 2007 Sep;36(3):329-35. doi: 10.1002/mus.20871.

Reference Type BACKGROUND
PMID: 17600820 (View on PubMed)

Ruano G, Thompson PD, Windemuth A, Smith A, Kocherla M, Holford TR, Seip R, Wu AH. Physiogenomic analysis links serum creatine kinase activities during statin therapy to vascular smooth muscle homeostasis. Pharmacogenomics. 2005 Dec;6(8):865-72. doi: 10.2217/14622416.6.8.865.

Reference Type BACKGROUND
PMID: 16296949 (View on PubMed)

Ruano G, Seip R, Windemuth A, Wu AH, Thompson PD. Laboratory Medicine in the Clinical Decision Support for Treatment of Hypercholesterolemia: Pharmacogenetics of Statins. Clin Lab Med. 2016 Sep;36(3):473-91. doi: 10.1016/j.cll.2016.05.010. Epub 2016 Jun 24.

Reference Type DERIVED
PMID: 27514463 (View on PubMed)

Ruano G, Windemuth A, Wu AH, Kane JP, Malloy MJ, Pullinger CR, Kocherla M, Bogaard K, Gordon BR, Holford TR, Gupta A, Seip RL, Thompson PD. Mechanisms of statin-induced myalgia assessed by physiogenomic associations. Atherosclerosis. 2011 Oct;218(2):451-6. doi: 10.1016/j.atherosclerosis.2011.07.007. Epub 2011 Jul 20.

Reference Type DERIVED
PMID: 21868014 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.harthosp.org/heart/default.aspx

Hartford Hospital \& the Henry Low Heart Center

http://www.rogosin.org/index.php?id=36

Rogosin Institute, affiliated with NY Presbyterian Hospital and Weill Cornell School of Medicine

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1 R44 HL091697-01

Identifier Type: -

Identifier Source: org_study_id