Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
---|---|
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00786474 |
Blood thinners, such as warfarin, prevent blood clots from forming, thereby reducing the risk of a stroke or heart attack. When people undergo surgery or certain procedures, they must stop using warfarin to prevent too much bleeding during and after the surgery or procedure. Some doctors prescribe a different blood thinner, one that works more quickly and wears off more quickly, to bridge the gap between starting and stopping warfarin. However, this short-term treatment is expensive, may increase the risk of bleeding, and has not been proven effective. This study will determine whether a bridging blood thinner called dalteparin is helpful or harmful for people with atrial fibrillation who stop taking warfarin in preparation for surgery or a procedure.
Condition | Intervention | Phase |
---|---|---|
Arterial Thromboembolic Events Atrial Fibrillation |
Drug: Placebo Drug: Dalteparin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Bridging Anticoagulation in Patients Who Require Temporary Interruption of Warfarin Therapy for an Elective Invasive Procedure or Surgery |
Estimated Enrollment: | 3626 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator |
Drug: Placebo
Normal saline solution, dosage determined by weight, self-administered by patient twice a day
|
Dalteparin: Experimental |
Drug: Dalteparin
Low molecular weight heparin (LMWH), dosage determined by weight, self-administered by patient twice a day
|
Approximately 2 million people in North America take the anticoagulant warfarin to prevent stroke, heart attack, and other events related to blood clots. Warfarin needs to be stopped before a person undergoes surgery or certain procedures because it can cause dangerous amounts of bleeding during and after surgery. Some doctors give a low molecular weight heparin (LMWH) to patients during the 2-week period when participants are without the effects of warfarin. The LMWH has the same effect as warfarin, but it acts and then leaves the system more quickly than warfarin. However, the LMWH is expensive, may increase the risk of bleeding, and has not been proven effective. This study will determine the safety and efficacy of an LMWH in adults with atrial fibrillation who stop warfarin in preparation for surgery.
Participation in this study will last between 36 and 67 days. Participation will involve nine points of contact with researchers, at least two of which will be in-person visits at the research clinic. The others will be conducted by phone. All points of contact will include assessments on possible bleeding and any new symptoms. The first two of these points of contact, occurring between 3 and 30 days before the scheduled surgery or procedure, will involve a screening of medical records and random assignment of participants to receive either the LMWH dalteparin or placebo. Participants will self-administer a subcutaneous injection of their assigned treatment twice a day for 3 days before the surgery or procedure and for 6 days after. During the course of the study, when participants visit their primary physicians for regularly scheduled appointments, they will also undergo three international normalized ratio (INR) tests of blood clotting ability. The remaining seven points of contact will occur sometime between the day before surgery and 37 days after surgery. One of the in-person visits will occur within the first week after surgery and will include assessments on possible bleeding, any new symptoms, and INR results.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Presence of one of the following conditions:
Presence of at least one of the following major stroke risk factors:
Exclusion Criteria:
Having one of the following surgeries or procedures during warfarin interruption:
Contact: Wanda G. Parker, RN, MSN | 919-668-8589 | parke010@dcri.duke.edu |
United States, North Carolina | |
Duke Clinical Research Institute | |
Durham, North Carolina, United States, 27715 |
Principal Investigator: | Thomas L. Ortel, MD | Duke University |
Principal Investigator: | Victor Hasselblad, PhD | Duke University |
Responsible Party: | Duke Clinical Research Institute ( Thomas Ortel, MD and Victor Hasselblad, PhD ) |
Study ID Numbers: | 598, 1U01HL086755-01A1 |
Study First Received: | November 5, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00786474 |
Health Authority: | United States: Federal Government |
Bridging Anticoagulation |
Embolism and Thrombosis Heart Diseases Dalteparin Embolism Heparin, Low-Molecular-Weight Vascular Diseases |
Warfarin Atrial Fibrillation Heparin Thrombosis Calcium heparin Arrhythmias, Cardiac |
Fibrin Modulating Agents Anticoagulants Pathologic Processes Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |