Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
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ClinicalTrials.gov Identifier: NCT00484640 |
Recruitment Status : Unknown
Verified June 2007 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was: Not yet recruiting
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation Deep Venous Thrombosis Heart Valve Replacement Pulmonary Embolism | Drug: Coumadin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 260 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing |
Study Start Date : | June 2007 |
Estimated Study Completion Date : | May 2008 |

- weighted time in therapeutic range
- absolute deviation from clinically optimal dose
- time to stable dose in therapeutic target range
- warfarin related adverse drug events
- time to first INR above 4

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Caucasian male and female patients(including Hispanic white) greater than or equal to 40 years of age;
- Patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
- Target INR of 2 to 3.5;
- Women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.
Exclusion Criteria:
- Age less than 40 years;
- Patients of known Native American, Asian, or African descent;
- Patients with thrombocytopenia(platelet count<50x10 cells/ml);
- Patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
- Patients with severe to moderate hepatic insufficiency (AST or ALT less than 2x the upper limit of normal;
- Clinical contraindication for coumadin therapy;
- Female patients with a positive pregnancy test or women who are breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484640
Contact: Deborah J Hilgemann, Res. Coord. | 715-389-3774 ext same | hilgemann.deborah@marshfieldclinic.org | |
Contact: Sandra K Strey, Res. Coord. | 715-389-4030 ext same | strey.sandra@marshfieldclinic.org |
United States, Wisconsin | |
Third Wave Molecular Diagnostics | |
Madison, Wisconsin, United States, 53719 | |
Sub-Investigator: Amy Brower, PhD | |
Marshfield Clinic | |
Marshfield, Wisconsin, United States, 54449 |
Principal Investigator: | Michael Caldwell, Physician | Marshfield Clinic Research Foundation |
ClinicalTrials.gov Identifier: | NCT00484640 |
Other Study ID Numbers: |
R01HS016335-01 ( U.S. AHRQ Grant/Contract ) |
First Posted: | June 11, 2007 Key Record Dates |
Last Update Posted: | June 11, 2007 |
Last Verified: | June 2007 |
Pulmonary Embolism Atrial Fibrillation Thrombosis Embolism Venous Thrombosis Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Embolism and Thrombosis Vascular Diseases Lung Diseases Respiratory Tract Diseases Warfarin Anticoagulants |