Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS)

This study has been completed.
Sponsor:
Collaborator:
Celera Genomics
Information provided by:
Medco Health Solutions, Inc.
ClinicalTrials.gov Identifier:
NCT01068834
First received: February 12, 2010
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Dyslipidemia
Genetic: KIF6 genetic test

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Additional KIF6 Risk Offers Better Adherence to Statins

Resource links provided by NLM:


Further study details as provided by Medco Health Solutions, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To determine cardiovascular costs associated with PDC [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

DNA samples


Enrollment: 1282
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068834

Locations
United States, New Jersey
Medco Health Solutions, Inc
Franklin Lakes, New Jersey, United States, 07417
Sponsors and Collaborators
Medco Health Solutions, Inc.
Celera Genomics
Investigators
Principal Investigator: Scott L Charland, PharmD Medco Health Solutions, Inc.
Principal Investigator: James J Devlin, PhD Celera Genomics
  More Information

Publications:
Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics 2009 update: A report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 119;e21-e181,2009.

Responsible Party: Scott L Charland, Pharm.D. Director, Clinical Research & Health Outcomes, Personalized Medicine, Medco Health Solutions, Inc
ClinicalTrials.gov Identifier: NCT01068834     History of Changes
Other Study ID Numbers: AKROBATS
Study First Received: February 12, 2010
Last Updated: January 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medco Health Solutions, Inc.:
Adherence
Statins
Kinesin-like protein 6

Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014