Ronald Pearl
To Compare the Use of an Oral Anticoagulant with a Standard of Care, Subcutaneous Injection in the Prevention of Venous Thromboembolism (Blood Clot).
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Subjects who have been hospitalized due to congestive heart failure or acute respiratory failure, infection (without septic shock), acute rheumatic disorder, or inflammatory bowel disease are at a risk for developing a blood clot (thrombus) in the deep veins of their legs. This can happen if the vein is injured or if the blood flow slows down or stops. A thrombus can cause painful swelling, tenderness, redness, warmth, and possibly long-term damage to the veins. This condition is called deep vein thrombosis or DVT. A blood clot or part of one can break off from the vein in the leg and can travel through the bloodstream to the lungs. When this happens, the condition is called pulmonary (lung) embolism (another name for a blood clot) or PE. Symptoms of PE may be shortness of breath, chest pain when taking deep breaths and coughing. A pulmonary embolism can be fatal. There are standard medicines to treat DVT and PE once signs and/or symptoms occur. Sometimes there are no warning signs that a DVT or PE is developing. In this study everyone will undergo a special test called a bilateral compression ultrasound, to show if there are harmful blood clots in your leg veins. The bilateral compression ultrasound will be conducted two times during the study. If a blood clot is found, your doctor can treat you for this condition before further problems develop. More information about the bilateral compression ultrasound is explained later on in the consent form. The purpose of this study is to compare how well two medications work to prevent deep-vein thrombosis (DVT). One is apixaban (BMS-562247), an experimental drug and the other is enoxaparin, a drug approved for the prevention of DVT which may lead to PE. The safety of apixaban will also be studied. Results from a previous clinical trial in over 900 subjects using multiple doses of apixaban suggest apixaban is generally well tolerated.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Apixaban
- Drug: Enoxaparin
Phase:
Phase 3Eligibility
Ages Eligible for Study:
40 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Inclusion Criteria:
men and non-pregnant, non-breastfeeding women
40 years or older
hospitalized with congestive heart failure or acute respiratory failure
infection (without septic shock)
acute rheumatic disorder
inflammatory bowel disease
Key Exclusion Criteria:
Exclusion Criteria:
patients with VTE
active bleeding or at high risk of bleeding
unable to take oral medication
with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ?? 165 mg/day.
Additional Study Details
Official Title:
A Phase 3 Randomized, Double-Blind, Parallel-Group, Multi-Center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following HospitalizationAnticipated start date:
6/1/2007Lead Sponsor:
Bristol-Myers SquibbInvestigator(s):
Study Type:
InterventionalPurpose:
PreventionAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Composite of venous thromboembolism (VTE) and VTE-related death [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: No ]
Secondary Outcomes:
- Secondary outcomes include all cause death, major bleeding, and clinically relevant non-major bleeding [ Time Frame: during 30 days of double-blind treatment ] [ Designated as safety issue: Yes ]
Total Number to be Enrolled:
6524Total Number to be Enrolled at Stanford:
15More Information
Secondary ID(s):
- IRB # 9505
- NCT00457002
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/10/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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