Anti-coagulation TherapyWARFARINNCT01305148
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
A study testing Warfarin GenoSTAT Test in people with Anti-coagulation Therapy and DVT, run by Iverson Genetic Diagnostics, Inc. at 56 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anti-coagulation Therapy, DVT, Pulmonary Embolism
- What is being tested?
- Warfarin GenoSTAT Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,800 participants
- Where
- 56 sitesUnited States
- Study dates
- Aug 2011to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Men and women at least 65 years old
- 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
Who cannot join
- Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- A previous genetically determined warfarin dose
- The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
United States56 sites
New Mexico Heart Institute
Albuquerque, New Mexico, 87102
Comprehensive Cardiovascular Specialists
Alhambra, California, 91801
Community Hospital Anderson
Anderson, Indiana, 46011
Mission Hospital
Asheville, North Carolina, 28801
Grady Hospital
Atlanta, Georgia, 30303
Cardiology of Atlanta
Atlanta, Georgia, 30328
Texas Cardiac Arrhythmia
Austin, Texas, 78705
Nexxus Research
Bedford, Texas, 76021
Overlake Hospital
Bellevue, Washington, 98004
Bend Memorial Clinic
Bend, Oregon, 97701
Billings Clinic
Billings, Montana, 59101
Veterans' Affairs Medical Center
Birmingham, Alabama, 35233
St. Alphonsus Regional Medical Center
Boise, Idaho, 83702
Aultman Hospital
Canton, Ohio, 44708
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
Palmetto Health Richland
Columbia, South Carolina, 29203
Corvallis Clinic
Corvallis, Oregon, 97330
Okaloosa Heart & Vascular
Crestview, Florida, 32539
Atlanta Heart Group
Decatur, Georgia, 30033
Colorado Heart & Vascular
Denver, Colorado, 80204
Henry Ford Hospital
Detroit, Michigan, 48202
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901
Family Health Care of Ellensburg
Ellensburg, Washington, 98926
St. Mary's
Evansville, Indiana, 47750
NECCR
Falls River, Massachusetts, 02720
Sanford Health Research
Fargo, North Dakota, 58122
Infinity-Northshore
Fort Lauderdale, Florida, 33313
Cardiovascular Consultants - Thunderbird
Glendale, Arizona, 85306
Nebraska Heart Institute
Grand Island, Nebraska, 68803
Hackensack Medical Center
Hackensack, New Jersey, 07601
Infinity Clinical Research
Hollywood, Florida, 33021
Kansas City Heart Foundation
Kansas City, Missouri, 64114
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48910
Nebraska Heart
Lincoln, Nebraska, 68526
Orthoarkansas
Little Rock, Arkansas, 72205
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
Medical Consultants, PC
Muncie, Indiana, 47303
Intermountain Medical Center
Murray, Utah, 84157
Heart Rhythm Specialists
Naples, Florida, 34119
St. Thomas Research Institute
Nashville, Tennessee, 37205
Alegent
Omaha, Nebraska, 68124
Cardiovascular Consultants - Phoenix
Phoenix, Arizona, 85015
Legacy Heart Center
Plano, Texas, 75024
Southern Heart Research Institute
Riverdale, Georgia, 30274
Carolina Cardiology
Rock Hill, South Carolina, 29732
Rockford Cardiovascular Research Foundation
Rockford, Illinois, 61107
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Polyclinic
Seattle, Washington, 98104
Swedish Hospital
Seattle, Washington, 98122
Cox Medical Center
Springfield, Missouri, 65807
St. Joseph's Medical Center
Stockton, California, 95204
Franciscan Research Center
Tacoma, Washington, 98405
Scott & White
Temple, Texas, 76508
Carle Foundation
Urbana, Illinois, 61801
Providence Health Network
Waco, Texas, 76712
About this study
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.
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple, Atrial Fibrillation, Prosthetic Replacement of Mitral Valve
- Being tested
- Warfarin GenoSTAT Test
- Keywords
- warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin
- Medical subject headings
- Pulmonary Embolism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin GenoSTAT TestDevice
Also called Warfarin GenoSTAT, pharmacogenetic testing, personalized medicine
Use of genetic information from the GenoSTAT test to determine the warfarin dose
| Study group | Role | What they receive |
|---|---|---|
| Randomized - Genetic | Experimental | 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 Receives: Device: Warfarin GenoSTAT Test |
| Randomized - Clinical | No intervention | 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 |
| Registry | Experimental | 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 Receives: Device: Warfarin GenoSTAT Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of warfarin related clinical events
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.
Measured: 30 days
Secondary outcomes (8)
INR Tests
Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Measured: 30 days
Warfarin Doses
Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Measured: 90 days
Hemorrhagic Events
The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
Measured: 90 days
Minor hemorrhagic events
The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
Measured: 90 days
Major thromboembolic events
The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
Measured: 90 days
INR tests
The percentage of the total INR tests performed in the first 30 days which are out of target range
Measured: 30 days
SF-12
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
Measured: 90 days
Prescriber adherence
Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Sponsor is raising funds for the remainder of the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-coagulation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iverson Genetic Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- An Pang Chieng, MD, Principal investigator, Alhambra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305148
- Sponsor's protocol ID
- IG-0109
- Acronym
- WARFARIN
- Status last verified
- Aug 2015
- First submitted
- 25 Feb 2011
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
- ClinicalTrials.gov ID
- NCT01305148
- Acronym / sponsor ID
- WARFARIN / IG-0109
- Conditions
- Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple, Atrial Fibrillation, Prosthetic Replacement of Mitral Valve
- Keywords
- warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Sponsor is raising funds for the remainder of the study
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- Iverson Genetic Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized - Genetic | Experimental | Device: Warfarin GenoSTAT TestSubjects 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 |
| Randomized - Clinical | No intervention | –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 |
| Registry | Experimental | Device: Warfarin GenoSTAT TestSubjects 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women at least 65 years old
- 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
Key exclusion criteria (3 listed)
- Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- A previous genetically determined warfarin dose
- The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin GenoSTAT TestAlso: Warfarin GenoSTAT, pharmacogenetic testing, personalized medicineUse of genetic information from the GenoSTAT test to determine the warfarin dose | Device | Randomized - Genetic, Registry |
Primary outcome
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.
8 secondary outcomes
INR Tests
Time frame: 30 days
Warfarin Doses
Time frame: 90 days
Hemorrhagic Events
Time frame: 90 days
Minor hemorrhagic events
Time frame: 90 days
Major thromboembolic events
Time frame: 90 days
INR tests
Time frame: 30 days
SF-12
Time frame: 90 days
Prescriber adherence
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
Related trials for Anti-coagulation Therapy
Active, not recruitingPhase 3
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Intracranial Arteriosclerosis, Stroke
Not yet recruitingPhase 4
Perioperative Dutasteride for Hemorrhage Control in Bipolar TURP Under Anticoagulation.
Benign Prostatic Hyperplasia, Postoperative Hemorrhage
Not yet recruitingObservational study
Magnesium Kinetics During Citrate-Anticoagulated CRRT
Continuous Renal Replacement Therapy (CRRT), Magnesium
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
Not yet recruitingPhase 1
Phase 1 Dose Escalation Study of RXIM002 in Autoimmune Cytopenias
Immune Thrombocytopenia (ITP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An Pang Chieng, MD principal investigator
Alhambra Hospital
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin GenoSTAT Test in people with Anti-coagulation Therapy and DVT, run by Iverson Genetic Diagnostics, Inc. at 56 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of warfarin related clinical events (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.