SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism

Completed · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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 (blood-thinning) drug, SR34006, with the standard way of treating a pulmonary embolism. The standard treatment includes injections or infusions of an anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by chance and will be known by both patients and their doctors.

Key facts

Study ID

NCT00062803

Run by

Sanofi

Starts

2003-06-01

Expected to finish

2005-10-01

Last updated by the study team

2009-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
• Written informed consent

You may not qualify if…

• 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

Where it is running

• University of California, San Diego Medical Center — San Diego, California, United States
• Anschutz Cancer Pavilion — Aurora, Colorado, United States
• University of Colorado Hospital — Denver, Colorado, United States
• Bay Pines VA Medical Center — Bay Pines, Florida, United States
• Brandon Regional Hospital — Brandon, Florida, United States
• Holmes Regional Medical Center — Melbourne, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• DeKalb Medical Center — Decatur, Georgia, United States
• Loyola University Medical Center and Outpatient Clinic — Maywood, Illinois, United States
• Olathe Medical Center — Olathe, Kansas, United States
• Christus St. Patrick Hospital — Lake Charles, Louisiana, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Joseph Mercy - Oakland — Pontiac, Michigan, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• William Beaumont Hospital — Troy, Michigan, United States
• Lovelace Health Systems, Clinical Thrombosis Center — Albuquerque, New Mexico, United States
• Winthrop Pulmonary Associates — Mineola, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Jerry L. Pettic VA Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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