The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings

NCT00830570 | Completed DMC

• 1 other identifier: MedcoWarfarin1
• Study Type: observational
• Target: 1,635
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this quasi-experiment study, which could also be classified as a prospective observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9) and vitamin K epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient care setting.

Conditions

Embolism and Thrombosis; Embolism; Vascular Diseases; Warfarin; Venous Thromboembolism; Thrombosis; Thromboembolism

Keywords

CYP2C9; VKORC1; polymorphism; warfarin; Coumadin

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to determine whether the addition of genotyping to usual care will reduce the hospitalization rates for hemorrhage or thromboembolism related to warfarin use during the first 6 months of treatment.

  6 months

Secondary Outcomes (1)

• The secondary objective is to determine physician and patient acceptance of the technology.

  6 months

Study Arms (3)

1

Historical control group. Patients in this group are drawn from the same plan populations as the intervention group, but they are identified during the 1-year period prior to the start of patient enrollment in the intervention group. The historical control group is closely matched with the intervention group on demographic characteristics, practice patterns, and benefit plan features that may affect resource utilization.

2

Concurrent control group. Patients in this group are drawn from different set of plan populations, but they initiate warfarin treatment during the same time period as patients in the intervention group. Outcomes data for the concurrent control group will be used to evaluate whether any differences between the intervention group and the historical control group can be attributed to changes in clinical practice over time. Baseline data for the concurrent control group will help validate the incidence assumptions used in the calculation of statistical power. This use of baseline population norms is an effective means of limiting bias in quasi-experimental studies.

3

Active study group. For plans participating in the active arm of the study, enrollment is offered to every patient who initiates warfarin therapy during the enrollment period (beginning in July 2007) and who meets the eligibility criteria. Patients are identified for the active study group if they have a warfarin pharmacy claim and no prior warfarin claims during the preceding 180 days. Only patients who remain eligible for the pharmacy benefit throughout the study period are included in the final sample.

Other: CYP 2C9 and VKORC1 Testing for Warfarin

Interventions

CYP 2C9 and VKORC1 Testing for Warfarin OTHER

Test patients for their warfarin sensitivity and provide this information to their physician authorizing the test.

Also known as: Genetic testing for drug sensitivity

3

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The active study population consists of male and female covered lives with Medco for clients have agreed to enroll their members for ages 40-75 for new warfarin starts who match the inclusion criteria.

You may qualify if:

• Female and male age range of 40-75
• Patients who are in the induction phase of warfarin
• Patients receiving warfarin to prevent or treat thromboembolic conditions (e.g., post orthopedic surgery prophylaxis, deep venous thrombosis, atrial fibrillation, pulmonary embolism, heart failure)
• Patient willing to provide informed consent prior to the specimen collection procedure
• Patient whose physician is willing to order the genetic test

You may not qualify if:

• Age \< 40 or \> 75
• Previous use of warfarin within 180 days of initiating new warfarin therapy
• Hospitalized for seven or more days before first claim for warfarin
• Previous history of genetic testing for warfarin therapy
• Known hypersensitivity to warfarin
• Patient or physician refusal to participate in the study
• Patients using warfarin residing in Olmsted County, MN

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead
• Mayo Clinic: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Medco Health Solutions, Inc.

Franklin Lakes, New Jersey, 07003, United States

Location

Related Publications (1)

• Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi: 10.1016/j.jacc.2010.03.009. Epub 2010 Apr 8.

  PMID: 20381283 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw and buccal swab

MeSH Terms

Conditions

Embolism and Thrombosis; Embolism; Vascular Diseases; Venous Thromboembolism; Thrombosis; Thromboembolism; Vitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2

Interventions

Warfarin; Genetic Testing

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Robert Epstein, MD, MS

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: July 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 16, 2010

Record last verified: 2010-11

Locations

US (1)