Additional KIF6 Risk Offers Better Adherence to Statins

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

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Recruitment Status

COMPLETED

Total Enrollment

1282 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-04-30

Brief Summary

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Many patients prescribed statins to lower their cholesterol stop taking their statin over time. The purpose of this study is to determine whether providing subjects their KIF6 carrier status (associated with increased cardiovascular event risk) will improve adherence to statin medications.

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Detailed Description

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Coronary Heart Disease (CHD) remains a significant problem in the US, causing about 1 of every 5 deaths in 2005. In 2009, approximately 1.3 million Americans will have a new/recurrent myocardial infarction. Coronary heart disease (CHD) includes myocardial infarction, stable or unstable angina, demonstrated myocardial ischemia detected by noninvasive testing, and a history of coronary artery procedures (such a stent or bypass). Currently, "statins" are recommended by the AHA to manage elevated low-density lipoprotein-cholesterol (LDL-C). Unfortunately, the discontinuation of statins is quite substantial. For example, a large cohort study of older patients found that 2-year statin adherence rates were approximately 40% for acute coronary syndrome patients, 36% for chronic coronary artery disease, and 25% for primary prevention and is associated with increased mortality, hospitalizations, and costs. Recently, the kinesin 6 (KIF6) gene has been associated with a 30-55% increase in cardiovascular events in individuals carrying one or two risk variants (\~57% of the white population) in multiple prospective studies. Furthermore, KIF6 carriers receiving a "statin" have a substantial greater cardiovascular risk reduction (-34 to 50%) when using a "statin" compared to those that are non-carriers using a statin (6 to 20%). In this prospective, open label, trial, recruited subjects recently started on statin therapy will be provided information about their KIF6 carrier status and followed for 6 months to determine their "statin" adherence. Additionally, quality of life and factors adherence will be measured at baseline and after 6 months. Finally, pharmacy records will be evaluated for up to 1-year to determine statin discontinuation rates.

Conditions

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Cardiovascular Diseases Dyslipidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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KIF6 tested

Recruited subjects, completing a valid KIF6 test with results

KIF6 genetic test

Intervention Type GENETIC

KIF6 carrier status with interpretation sheet provided to subject

KIF6 test naïve

Database matched cohort not receiving a KIF6 test

No interventions assigned to this group

Interventions

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KIF6 genetic test

KIF6 carrier status with interpretation sheet provided to subject

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

* Men and women at least 18 years of age
* New statin prescription
* Medco RationalMed® Program
* Data contains patient contact information (e.g. phone number)
* Data contains provider contact information
* Willing to sign informed consent and send KIF6 test results to their provider

Exclusion Criteria

* Statin prescription in the previous 6 months
* Subject refusal to participate in this study (record reason from subject)
* Physician refusal to participate in this study (record reason from provider)
* Anticipated statin discontinuation within 6 months
* Any condition that would prevent the subject from completing the 6 month study follow-up period
* Subject with "no contact red flag"
* Subject residing in NY, NJ, MA, PA

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No