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NCT00401414 · ClinicalTrials.gov registry record · NA
Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information
A NA study of Atrial Fibrillation and Pulmonary Embolism, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 344
- Enrollment target
- 2
- Study locations
NCT00401414 is a NA study of Atrial Fibrillation and Pulmonary Embolism that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 344 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00401414, a NA study of Atrial Fibrillation and Pulmonary Embolism, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 344 participants
- Enrollment target
- 2
- Study locations
Study Summary
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,
Conditions Studied
Interventions
- DRUG Warfarin
Study Locations (2)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00401414
The ClinicalTrials.gov registry entry for NCT00401414 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (89% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Warfarin is the first listed.
NCT00401414 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00401414 about?
NCT00401414 is a clinical study titled "Study to Develop a Reliable Nomogram That Incorporates Clinical and Genetic Information". 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 ...
What is the current status of trial NCT00401414?
This trial is currently completed. It is a NA study. The enrollment target is 344 participants. The study started on 2007-01. Estimated completion is 2011-06.
What conditions does trial NCT00401414 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis.
What interventions are being tested in trial NCT00401414?
The interventions under investigation include: Warfarin (DRUG).
Who is sponsoring clinical trial NCT00401414?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00401414 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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