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

Purpose

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.

Condition	Intervention	Phase
Pulmonary Embolism Deep Vein Thrombosis	Drug: SR34006 (idraparinux sodium) Injection	Phase III

MedlinePlus related topics:

Blood Thinners Deep Vein Thrombosis Pulmonary Embolism

Drug Information available for:

Vitamin K

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Safety/Efficacy Study

Official Title:	The Van Gogh-Extension Trial, a Multicenter, International, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With Placebo in the Long-Term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-Vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Symptomatic recurrent PE/DVT during the 6-month study treatment period.

Secondary Outcome Measures:

Major bleeding during the 6-month study treatment period.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071279

Show 65 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications indexed to this study:

van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC5135/64721, SR34006
First Received:	October 16, 2003
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00071279
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Embolism and Thrombosis

Pulmonary Embolism

Respiratory Tract Diseases

Embolism

Lung Diseases

Vitamin K

Vascular Diseases

Venous Thrombosis

Venous Thromboembolism

Thromboembolism

Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00071279