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

Pulmonary Embolism Clinical Trial

Official title:

The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062803
• Other study ID #: EFC3484
• Status: Completed
• Phase: Phase 3
• First received: June 16, 2003
• Last updated: April 28, 2009
• Start date: June 2003
• Est. completion date: October 2005

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Written informed consent

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• SR34006

• (LMW)heparin

• Warfarin VKA

• Acenocoumarol VKA

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	QEII Health Sciences Center	Halifax	Nova Scotia
Canada	Hamilton Health Sciences - General Hospital	Hamilton	Ontario
Canada	Kelowna General Hospital	Kelowna	British Columbia
Canada	London Health Sciences Centre	London	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Ottawa Hospital - Civic Campus	Ottawa	Ontario
Canada	Hotel-Dieu de St-Jerome	St-Jerome	Quebec
Canada	University Health Network, Toronto General Hospital	Toronto	Ontario
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Humber River Regional Hospital	Weston	Ontario
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Akron General Medical Center	Akron	Ohio
United States	Lovelace Health Systems, Clinical Thrombosis Center	Albuquerque	New Mexico
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Northwest Texas Healthcare System	Amarillo	Texas
United States	Medical College of Georgia	Augusta	Georgia
United States	Anschutz Cancer Pavilion	Aurora	Colorado
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Bay Pines VA Medical Center	Bay Pines	Florida
United States	Boston Medical Center	Boston	Massachusetts
United States	Brandon Regional Hospital	Brandon	Florida
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	MedSource, Inc.	Chesapeake	Virginia
United States	Portsmouth Pulmonary Associates	Chesapeake	Virginia
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	DeKalb Medical Center	Decatur	Georgia
United States	University of Colorado Hospital	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Pulmonary Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	Altru Health System Hospital	Grand Forks	North Dakota
United States	The Methodist Hospital	Houston	Texas
United States	Christus St. Patrick Hospital	Lake Charles	Louisiana
United States	Jerry L. Pettic VA Medical Center	Loma Linda	California
United States	Loyola University Medical Center and Outpatient Clinic	Maywood	Illinois
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Baptist Memorial Hospital Memphis	Memphis	Tennessee
United States	The West Cancer Clinic	Memphis	Tennessee
United States	Jackson Memorial Hospital	Miami	Florida
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	St. Luke's-Roosevelt Hospital Center	New York	New York
United States	INTEGRIS Southwest Medical Center	Oklahoma City	Oklahoma
United States	Oklahoma City VA Medical Center	Oklahoma City	Oklahoma
United States	OU Medical Center	Oklahoma City	Oklahoma
United States	Saint Anthony Hospital	Oklahoma City	Oklahoma
United States	Olathe Medical Center	Olathe	Kansas
United States	St. Joseph Mercy - Oakland	Pontiac	Michigan
United States	Maryview Medical Center	Portsmouth	Virginia
United States	McGuire VA Medical Center	Richmond	Virginia
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University Hospital	Salt Lake City	Utah
United States	University of California, San Diego Medical Center	San Diego	California
United States	Swedish Medical Center	Seattle	Washington
United States	Mary Black Memorial Hospital	Spartanburg	South Carolina
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Sacred Heart Medical Center	Spokane	Washington
United States	Baystate Medical Center	Springfield	Massachusetts
United States	St. Joseph's Hospital	Tampa	Florida
United States	Scott & White Memorial Hospital & Clinic	Temple	Texas
United States	Medical College of Ohio	Toledo	Ohio
United States	William Beaumont Hospital	Troy	Michigan
United States	The University of Texas Health Center at Tyler	Tyler	Texas
United States	Crozer-Chester Medical Center	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary	symptomatic recurrent PE/DVT within 6 months.

External Links

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