Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS)

Medco Health Solutions

Status

Completed

Conditions

Dyslipidemia

Cardiovascular Diseases

Treatments

Genetic: KIF6 genetic test

Study type

Observational

Funder types

Industry

Identifiers

NCT01068834

AKROBATS

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,282 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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