Status:
COMPLETED
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
Lead Sponsor:
Sanofi
Conditions:
Pulmonary Embolism
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (bl...
Eligibility Criteria
Inclusion
- Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
- Written informed consent
Exclusion
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE
- Other indication for VKA than PE/DVT
- More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW)heparin or initiation of VKA treatment prior to randomization
- Participation in another pharmacotherapeutic study within the prior 30 days
- Creatinine clearance \<10 mL/min, severe hepatic disease, or bacterial endocarditis
- Life expectancy \<3 months
- Active bleeding or high risk for bleeding
- Uncontrolled hypertension: systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg
- Pregnancy or childbearing potential without proper contraceptive measures or women who are breastfeeding
- Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin, enoxaparin, or tinzaparin
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00062803
Start Date
June 1 2003
End Date
October 1 2005
Last Update
April 29 2009
Active Locations (93)
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1
Jerry L. Pettic VA Medical Center
Loma Linda, California, United States
2
University of California, San Diego Medical Center
San Diego, California, United States
3
Anschutz Cancer Pavilion
Aurora, Colorado, United States
4
University of Colorado Hospital
Denver, Colorado, United States