Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|
|
Pulmonary Embolism Deep Vein Thrombosis Atrial Fibrillation |
Drug: Warfarin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CReating an Optimal Warfarin Nomogram (CROWN) Trial |
- Primary end point: mean percentage of time that INR within therapeutic range using linear interpolation (Rosendaal et al). [ Time Frame: 90 Days ] [ Designated as safety issue: No ]Primary end point: mean percentage of time INR is within therapeutic range. Though target INR was 2.0-3.0, therapeutic INR is considered 1.8-3.2 (allows for INR measurement error and avoids problems inherent in overcorrection). Secondary end points: 1) time to first therapeutic INR, 2) per-patient percentage of INRs out of therapeutic range, 3) time to stable anticoagulation, and 4) proportion of patients with serious adverse clinical events, defined as INR > 4.0, use of vitamin K, major bleeding events thromboembolic events, stroke (all cause), myocardial infarction, and death (all cause).
| Estimated Enrollment: | 500 |
| Study Start Date: | January 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
-
Drug: Warfarin
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18 years old
- Any newly diagnosed condition that will require treatment with therapeutic doses of warfarin for at least 4-6 weeks, e.g. deep venous thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation (AF), orthopedic surgery, etc.
- Written informed consent
Exclusion Criteria:
- Current treatment with warfarin
Contraindication to therapeutic anticoagulation:
- Active major bleeding
- History of intracranial bleeding
- Surgery, delivery, organ biopsy within 3 days
- Gastrointestinal bleeding within 10 days
- Major trauma within 3 days
- Head injury requiring hospitalization within 3 months
- Intracranial tumor
- Neurosurgery or ophthalmologic surgery within the past month
- Life expectancy < 3 months
- Pregnancy
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Mark A Creager, MD | Brigham and Women's Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Mark A. Creager, MD, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00401414 History of Changes |
| Other Study ID Numbers: | 2006-P-001896 |
| Study First Received: | November 16, 2006 |
| Last Updated: | June 24, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Warfarin Thrombosis Genetics Nomogram Pulmonary Embolism Deep Vein Thrombosis |
Dosing INR Anticoagulation Therapy Orthopedic Surgery |
Additional relevant MeSH terms:
|
Atrial Fibrillation Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |
Embolism and Thrombosis Vascular Diseases Lung Diseases Respiratory Tract Diseases Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013