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Additional KIF6 Risk Offers Better Adherence to Statins (AKROBATS)

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ClinicalTrials.gov Identifier: NCT01068834
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : February 1, 2012
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cardiovascular Diseases Dyslipidemia Genetic: KIF6 genetic 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.

Study Design

Study Type : Observational
Actual Enrollment : 1282 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Additional KIF6 Risk Offers Better Adherence to Statins
Study Start Date : March 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status [ Time Frame: 6 months ]
  2. To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve [ Time Frame: 6 months ]
  3. To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers [ Time Frame: 6 months ]
  4. To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects [ Time Frame: up to 12 months ]
  5. 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. 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 ]
  7. To determine cardiovascular costs associated with PDC [ Time Frame: 6 months ]

Biospecimen Retention:   Samples With DNA
DNA samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01068834

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

Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. Erratum in: Circulation. 2011 Oct 18;124(16):e424. Circulation. 2010 Jul 6;122(1):e11. Circulation. 2009 Jan 27;119(3):e182.

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
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: February 1, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents