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Sponsors and Collaborators: |
Brigham and Women's Hospital Massachusetts General Hospital Newton-Wellesley Hospital Faulkner Hospital Spaulding Rehabilitation Hospital |
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Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00401414 |
In this research study, the investigators are trying to find a better way to set the dose of a common blood-thinning medication. Patients with blood clots or a risk of blood clots (or stroke) sometimes have to take an approved medication called warfarin. Warfarin is a commonly prescribed, approved blood thinning medicine taken by mouth. There is a certain level of warfarin that is best for each patient at a particular time. It is hard for a doctor to choose and maintain the right dose of warfarin for each patient. Too much or too little warfarin in the blood can cause serious health problems. A "nomogram" is a tool that helps doctors decide on the right dose of warfarin. The usual way for finding the right dose of warfarin is for doctors to take an educated guess and use a "trial and error" approach. Patients have frequent blood tests to help doctors keep track of how well the dose level is working.
Up until now, if a patient had good blood test results over half of the time, that was as well as doctors could do. The purpose of this study is to see whether the investigators can create a reliable new warfarin nomogram that will allow them to dose a patient correctly more often, perhaps about 3 times out of 4. The nomogram the investigators are studying uses information about a patient's health and genes to decide on the best dose of warfarin. The investigators don't yet have a reliable, safe way to choose the correct dose. In this study, the investigators will use a genetic blood test to try to find a better way. Genes are the parts of each living cell that allow characteristics to be passed on from parents to children. The investigators know that people with certain genes seem to respond to warfarin in a certain way. From a blood sample, the investigators can look at patients' genes and try to predict the response to the blood-thinning medication.
There will be about 500 subjects taking part in this study. They will come from participating Partners' Hospitals, including Brigham and Women's Hospital, Massachusetts General Hospital, Faulkner Hospital, Newton-Wellesley Hospital, Spaulding Rehabilitation Hospital, and North Shore Medical Center. The U.S. Food and Drug Administration (FDA) has approved warfarin for use as a blood thinner.
Condition | Intervention |
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Pulmonary Embolism Deep Vein Thrombosis Atrial Fibrillation |
Drug: Warfarin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | CReating an Optimal Warfarin Nomogram (CROWN) Trial |
Estimated Enrollment: | 500 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindication to therapeutic anticoagulation:
Contact: Mark A Creager, MD | 617-732-5267 | mcreager@partners.org |
Contact: Nicole Navarette | 617-732-5267 | nnavarette@partners.org |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Mark A Creager, MD 617-732-5267 mcreager@partners.org | |
Contact: Nicole Navarette 617-732-5267 nnavarette@partners.org | |
Principal Investigator: Mark A Creager, MD | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Mason W Freeman, MD 617-726-5906 mfreeman@partners.org | |
Contact: Barbara Mahoney, RN 617-726-7960 bmahoney1@partners.org | |
Sub-Investigator: Michael R. Jaff, MD | |
Principal Investigator: Mason Freeman, MD | |
Faulkner Hospital | Recruiting |
Jamaica Plain, Massachusetts, United States, 02130 | |
Contact: Stephen C. Wright, MD 617-983-7448 scwright@partners.org | |
Contact: Anne Etienne, PharmD 617-983-7835 aetienne@partners.org | |
Principal Investigator: Stephen C. Wright, MD | |
Sub-Investigator: Anne Etienne, PharmD | |
Sub-Investigator: Marcella Calfon, MD | |
Newton-Wellesley Hospital | Recruiting |
Newton, Massachusetts, United States, 02462 | |
Contact: Caroline C. Block, MD 781-237-0700 cblock@partners.org | |
Contact: Laurie J. Schmitt, PharmD 617-243-5058 lschmitt1@partners.org | |
Principal Investigator: Caroline C. Block, MD | |
Sub-Investigator: Laurie Schmitt, PharmD | |
Sub-Investigator: Brenda E. Haynes, MD | |
Sub-Investigator: Timothy P. O'Connor, MD | |
Sub-Investigator: Marcia Browne, MD | |
Sub-Investigator: Jeffery Wisch, MD | |
Spaulding Rehabilitation Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: David M. Crandell, MD 617-643-2420 dcrandell@partners.org | |
Principal Investigator: David M. Crandell, MD |
Principal Investigator: | Mark A Creager, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Mark A. Creager, MD ) |
Study ID Numbers: | 2006-P-001896 |
Study First Received: | November 16, 2006 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00401414 History of Changes |
Health Authority: | United States: Institutional Review Board |
Warfarin Thrombosis Genetics Nomogram Pulmonary Embolism Deep Vein Thrombosis |
Dosing INR Anticoagulation Therapy Orthopedic Surgery |
Pulmonary Embolism Heart Diseases Anticoagulants Vascular Diseases Warfarin Thrombosis Embolism and Thrombosis |
Respiratory Tract Diseases Embolism Lung Diseases Venous Thrombosis Atrial Fibrillation Arrhythmias, Cardiac |
Anticoagulants Pulmonary Embolism Heart Diseases Hematologic Agents Vascular Diseases Warfarin Pharmacologic Actions Thrombosis Embolism and Thrombosis |
Pathologic Processes Respiratory Tract Diseases Embolism Therapeutic Uses Lung Diseases Venous Thrombosis Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |