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

Tracking Information

First Received Date ^ICMJE

October 16, 2003

Last Updated Date

April 28, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00071279 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Major bleeding during the 6-month study treatment period.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Safety/Efficacy Study

Condition ^ICMJE

Pulmonary Embolism
Deep Vein Thrombosis

Intervention ^ICMJE

Drug: SR34006 (idraparinux sodium) Injection

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00071279

Responsible Party

ICD Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

EFC5135, SR34006

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP