Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN) (WARFARIN)

• ClinicalTrials.gov Identifier: NCT01305148
• Recruitment Status: Suspended
• First Posted: February 28, 2011
• Last Update Posted: August 31, 2015
• Sponsor: Iverson Genetic Diagnostics, Inc.
• Information provided by (Responsible Party): Iverson Genetic Diagnostics, Inc.

Study Description

Brief Summary:

The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to warfarin.

Condition or disease	Intervention/treatment	Phase
Anti-coagulation Therapy; DVT; Pulmonary Embolism; Joint Surgery Multiple; Atrial Fibrillation; Prosthetic Replacement of Mitral Valve	Device: Warfarin GenoSTAT Test	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 3800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
• Study Start Date: August 2011
• Estimated Primary Completion Date: December 2015
• Estimated Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Randomized - Genetic; Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website	Device: Warfarin GenoSTAT Test; Use of genetic information from the GenoSTAT test to determine the warfarin dose; Other Names: Warfarin GenoSTAT; pharmacogenetic testing; personalized medicine
No Intervention: Randomized - Clinical; Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from clinical information alone through the warfarindosing.org website
Experimental: Registry; Subjects who are followed 30 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website	Device: Warfarin GenoSTAT Test; Use of genetic information from the GenoSTAT test to determine the warfarin dose; Other Names: Warfarin GenoSTAT; pharmacogenetic testing; personalized medicine

Outcome Measures

Primary Outcome Measures :

1. Incidence of warfarin related clinical events [ Time Frame: 30 days ]
   To determine if using warfarin-related pharmacogenetic information in calculating warfarin doses will change the incidence of warfarin-related clinical events, including major hemorrhage and thromboembolic events, at 30 days after initial dose, when compared to warfarin doses calculated without pharmacogenetic data.

Secondary Outcome Measures :

1. INR Tests [ Time Frame: 30 days ]
   Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
2. Warfarin Doses [ Time Frame: 90 days ]
   Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
3. Hemorrhagic Events [ Time Frame: 90 days ]
   The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
4. Minor hemorrhagic events [ Time Frame: 90 days ]
   The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
5. Major thromboembolic events [ Time Frame: 90 days ]
   The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
6. INR tests [ Time Frame: 30 days ]
   The percentage of the total INR tests performed in the first 30 days which are out of target range
7. SF-12 [ Time Frame: 90 days ]
   The overall, Physical Composite Score (PCS) and Mental Composite Score (MCS) of the SF-12 quality of life questionnaire at 30 days and at 90 days separately after warfarin initiation
8. Prescriber adherence [ Time Frame: 30 days ]
   Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Men and women at least 65 years old
2. Beginning warfarin (0 - 3 doses of warfarin taken at the time of enrollment) for a variety of diseases or conditions that require at least 30 days oral anticoagulation with target INR ≥ 2.0

Exclusion Criteria:

1. Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
2. A previous genetically determined warfarin dose
3. The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study

Contacts and Locations

  Show 56 Study Locations

Sponsors and Collaborators

Iverson Genetic Diagnostics, Inc.

Investigators

• Principal Investigator: An Pang Chieng, MD; Alhambra Hospital

More Information

Additional Information:

WARFARIN Study main website 

• Responsible Party: Iverson Genetic Diagnostics, Inc.
• ClinicalTrials.gov Identifier: NCT01305148 History of Changes
• Other Study ID Numbers: IG-0109
• First Posted: February 28, 2011
• Last Update Posted: August 31, 2015
• Last Verified: August 2015

Keywords provided by Iverson Genetic Diagnostics, Inc.:

warfarin; genetic testing; personalized medicine; anti-coagulants; coumadin

Additional relevant MeSH terms:

Warfarin; Pulmonary Embolism; Atrial Fibrillation; Embolism; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Embolism and Thrombosis; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Anticoagulants