Clinical trial NCT01068834: Additional KIF6 Risk Offers Better Adherence to Statins
Official title: Additional KIF6 Risk Offers Better Adherence to Statins
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Dyslipidemia
Keywords: Adherence
Statins
Kinesin-like protein 6
Lead sponsor: Medco Health Solutions, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Celera Genomics
First posted: 2010-02-15
Enrollment: 1282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults (\> 18y/o) newly started on either a brand name or generic statin (atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin with or without ezetimibe) being followed in Medco's RationalMed® program

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status
timeFrame: 6 months
measure: To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve
timeFrame: 6 months
measure: To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers
timeFrame: 6 months
measure: To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects
timeFrame: up to 12 months
measure: 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
timeFrame: 6 month
measure: 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
timeFrame: 6 months
measure: To determine cardiovascular costs associated with PDC
timeFrame: 6 months
Other outcomes:
Locations:
city: Franklin Lakes
country: United States
facility: Medco Health Solutions, Inc
state: New Jersey
Study officials:
affiliation: Medco Health Solutions, Inc.
name: Scott L Charland, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Celera Genomics
name: James J Devlin, PhD
role: PRINCIPAL_INVESTIGATOR
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