Additional KIF6 Risk Offers Better Adherence to Statins

NCT01068834 | Completed

• 1 other identifier: AKROBATS
• Study Type: observational
• Target: 1,282
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Dyslipidemia

Keywords

Adherence; Statins; Kinesin-like protein 6

Outcome Measures

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)

  6 months

Secondary Outcomes (7)

• To evaluate characteristics of subjects who agree to be tested for KIF6 carrier status

  6 months

• To evaluate adherence rate or medication gap in KIF6 carriers compared to KIF6 test naïve

  6 months

• To compare the PDC, MPR and or gap in KIF6 carriers and KIF6 non-carriers

  6 months

• To compare statin discontinuation rates between KIF6 carriers, non-carriers, and KIF6 test naïve subjects

  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

  6 month

Study Arms (2)

KIF6 tested

Recruited subjects, completing a valid KIF6 test with results

Genetic: KIF6 genetic test

KIF6 test naïve

Database matched cohort not receiving a KIF6 test

Interventions

KIF6 genetic test GENETIC

KIF6 carrier status with interpretation sheet provided to subject

KIF6 tested

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead
• Celera Genomics: collaborator

Study Sites (1)

Medco Health Solutions, Inc

Franklin Lakes, New Jersey, 07417, United States

Location

Related Publications (9)

• 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. No abstract available.

  PMID: 19075105 BACKGROUND

• National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available.

  PMID: 12485966 BACKGROUND

• Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA. 2002 Jul 24-31;288(4):462-7. doi: 10.1001/jama.288.4.462.

  PMID: 12132976 BACKGROUND

• Ho PM, Magid DJ, Shetterly SM, Olson KL, Maddox TM, Peterson PN, Masoudi FA, Rumsfeld JS. Medication nonadherence is associated with a broad range of adverse outcomes in patients with coronary artery disease. Am Heart J. 2008 Apr;155(4):772-9. doi: 10.1016/j.ahj.2007.12.011.

  PMID: 18371492 BACKGROUND

• Iakoubova OA, Sabatine MS, Rowland CM, Tong CH, Catanese JJ, Ranade K, Simonsen KL, Kirchgessner TG, Cannon CP, Devlin JJ, Braunwald E. Polymorphism in KIF6 gene and benefit from statins after acute coronary syndromes: results from the PROVE IT-TIMI 22 study. J Am Coll Cardiol. 2008 Jan 29;51(4):449-55. doi: 10.1016/j.jacc.2007.10.017.

  PMID: 18222355 BACKGROUND

• Iakoubova OA, Tong CH, Rowland CM, Kirchgessner TG, Young BA, Arellano AR, Shiffman D, Sabatine MS, Campos H, Packard CJ, Pfeffer MA, White TJ, Braunwald E, Shepherd J, Devlin JJ, Sacks FM. Association of the Trp719Arg polymorphism in kinesin-like protein 6 with myocardial infarction and coronary heart disease in 2 prospective trials: the CARE and WOSCOPS trials. J Am Coll Cardiol. 2008 Jan 29;51(4):435-43. doi: 10.1016/j.jacc.2007.05.057.

  PMID: 18222353 BACKGROUND

• Morrison AC, Bare LA, Chambless LE, Ellis SG, Malloy M, Kane JP, Pankow JS, Devlin JJ, Willerson JT, Boerwinkle E. Prediction of coronary heart disease risk using a genetic risk score: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2007 Jul 1;166(1):28-35. doi: 10.1093/aje/kwm060. Epub 2007 Apr 18.

  PMID: 17443022 BACKGROUND

• Shiffman D, Chasman DI, Zee RY, Iakoubova OA, Louie JZ, Devlin JJ, Ridker PM. A kinesin family member 6 variant is associated with coronary heart disease in the Women's Health Study. J Am Coll Cardiol. 2008 Jan 29;51(4):444-8. doi: 10.1016/j.jacc.2007.09.044.

  PMID: 18222354 BACKGROUND

• Shiffman D, O'Meara ES, Bare LA, Rowland CM, Louie JZ, Arellano AR, Lumley T, Rice K, Iakoubova O, Luke MM, Young BA, Malloy MJ, Kane JP, Ellis SG, Tracy RP, Devlin JJ, Psaty BM. Association of gene variants with incident myocardial infarction in the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):173-9. doi: 10.1161/ATVBAHA.107.153981. Epub 2007 Nov 1.

  PMID: 17975119 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

DNA samples

MeSH Terms

Conditions

Cardiovascular Diseases; Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Scott L Charland, PharmD

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

• James J Devlin, PhD

  Celera Genomics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: February 15, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 1, 2012

Record last verified: 2012-01

Locations

US (1)