SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis

Completed · Phase 3

Conditions studied: Pulmonary Embolism, Deep Vein Thrombosis

In brief

Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur. In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo. Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.

Key facts

Study ID

NCT00071279

Run by

Sanofi

People needed

1215

Starts

2003-11-01

Expected to finish

2005-12-01

Last updated by the study team

2011-04-06

Who can join

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

You may qualify if…

• Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
• Written informed consent

You may not qualify if…

• Legal age limitations (country specific)
• Indication for anticoagulation other than PE or DVT
• Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis
• Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
• Life expectancy <3 months
• Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 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, women who are breastfeeding.

Where it is running

• Pulmonary Associates of Brandon — Brandon, Florida, United States
• Jacksonville Cardiovascular Clinic — Jacksonville, Florida, United States
• Melbourne Internal Medicine Associates (MIMA) — Melbourne, Florida, United States
• Melbourne Internal Medical Associates (MIMA) — Palm Bay, Florida, United States
• Clinical Pharmacology Services — Tampa, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Cardinal Bernardin Cancer Center — Maywood, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office — Bloomfield Hills, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• St. Joseph Mercy - Oakland Clinical Research Office — Pontiac, Michigan, United States
• St. Joseph Mercy - Oakland — Pontiac, Michigan, United States
• William Beaumont Hospital / Clinical Research Center — Royal Oak, Michigan, United States
• William Beaumont Hospital Troy — Troy, Michigan, United States
• Lovelace Sandia Health Systems, Clinical Thrombosis Center — Albuquerque, New Mexico, United States
• University of New Mexico Hospital — Albuquerque, New Mexico, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Crozer-Chester Medical Center — Upland, Pennsylvania, United States
• Lung & Chest Medical Associates — Spartanburg, South Carolina, United States
• Spartanburg Pharmaceutical Research — Spartanburg, South Carolina, United States
• Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
• The Methodist Hospital — Houston, Texas, United States
• Scott and White Memorial Hospital and Clinic — Temple, Texas, United States
• Bay Pines VA Medical Center — Bay Pines, Florida, United States

Full record on ClinicalTrials.gov

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