Additional KIF6 Risk Offers Better Adherence to Statins

Completed

• Conditions: Cardiovascular Diseases; Dyslipidemia
• Interventions: Genetic: KIF6 genetic test

• Registration Number: NCT01068834
• Lead Sponsor: Medco Health Solutions, Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Study Start: 2010-03
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1282

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KIF6 tested	KIF6 genetic test	Recruited subjects, completing a valid KIF6 test with results

Primary Outcome Measures

Name	Time	Method
Proportion of days covered with statins in subjects tested for KIF6 status compared to statin-treated subjects who are not offered the test (KIF6 test naïve)	6 months

Secondary Outcome Measures

Name	Time	Method
To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects	up to 12 months
To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status	6 months
To compare SF-12 v2 summary measure scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS); and, a health utility index (SF-6D.), as well as, the Morisky Adherence Scale between KIF6 carriers and non-carriers	6 months
To determine cardiovascular costs associated with PDC	6 months
To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers	6 months
To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve	6 months
Shift in PDC between non-adherent, partially adherent, and adherent (< 0.2, >0.2 to <0.8, > 0.8, respectively) between KIF6 tested and KIF6 test naïve subjects	6 month

Trial Locations

Locations (1)

Medco Health Solutions, Inc; 🇺🇸 Franklin Lakes, New Jersey, United States