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OpenTrials
Completed

NCT Number: NCT01068834

Additional KIF6 Risk Offers Better Adherence to Statins

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medco Health Solutions, Inc

Franklin Lakes, New Jersey, 07417, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KIF6 genetic test

Genetic

KIF6 carrier status with interpretation sheet provided to subject

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medco Health Solutions, Inc.

Industry

Collaborators

  • Celera Genomics

Registry information

Acronym: AKROBATS

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 15, 2010
Registry last updated
Feb 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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