Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS)

January 30, 2012 updated by: Medco Health Solutions, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1282

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Franklin Lakes, New Jersey, United States, 07417
        • Medco Health Solutions, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
KIF6 tested
Recruited subjects, completing a valid KIF6 test with results
Genetic: KIF6 genetic test
KIF6 carrier status with interpretation sheet provided to subject
KIF6 test naïve
Database matched cohort not receiving a KIF6 test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status
Time Frame: 6 months
6 months
To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve
Time Frame: 6 months
6 months
To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers
Time Frame: 6 months
6 months
To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects
Time Frame: up to 12 months
up to 12 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
Time Frame: 6 month
6 month
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
Time Frame: 6 months
6 months
To determine cardiovascular costs associated with PDC
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medco Health Solutions, Inc.

Collaborators

Celera Genomics

Investigators

  • Principal Investigator: Scott L Charland, PharmD, Medco Health Solutions, Inc.
  • Principal Investigator: James J Devlin, PhD, Celera Genomics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

February 1, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKROBATS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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