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

NCT00062803 | Completed Phase 3

• 1 other identifier: EFC3484
• Study Type: interventional
• Target: N/A
• Locations: 19 countries
• Sites: 91

Brief 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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.

Secondary Outcomes (1)

• symptomatic recurrent PE/DVT within 6 months.

Interventions

SR34006 DRUG

(LMW)heparin DRUG

Warfarin VKA DRUG

Acenocoumarol VKA DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (93)

Jerry L. Pettic VA Medical Center

Loma Linda, California, United States

Location

University of California, San Diego Medical Center

San Diego, California, United States

Location

Anschutz Cancer Pavilion

Aurora, Colorado, United States

Location

University of Colorado Hospital

Denver, Colorado, United States

Location

Bay Pines VA Medical Center

Bay Pines, Florida, 33744, United States

Location

Brandon Regional Hospital

Brandon, Florida, 33511, United States

Location

Holmes Regional Medical Center

Melbourne, Florida, 32901, United States

Location

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

St. Joseph's Hospital

Tampa, Florida, 33607, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

DeKalb Medical Center

Decatur, Georgia, 30033, United States

Location

Loyola University Medical Center and Outpatient Clinic

Maywood, Illinois, 60153, United States

Location

Olathe Medical Center

Olathe, Kansas, United States

Location

Christus St. Patrick Hospital

Lake Charles, Louisiana, 70601, United States

Location

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Location

Boston Medical Center

Boston, Massachusetts, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. Joseph Mercy - Oakland

Pontiac, Michigan, 48341, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Lovelace Health Systems, Clinical Thrombosis Center

Albuquerque, New Mexico, 87108, United States

Location

Winthrop Pulmonary Associates

Mineola, New York, 11501, United States

Location

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

St. Luke's-Roosevelt Hospital Center

New York, New York, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Altru Health System Hospital

Grand Forks, North Dakota, 58201, United States

Location

Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Medical College of Ohio

Toledo, Ohio, 43614, United States

Location

Saint Anthony Hospital

Oklahoma City, Oklahoma, 73101, United States

Location

Oklahoma City VA Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

OU Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

INTEGRIS Southwest Medical Center

Oklahoma City, Oklahoma, 73109, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Crozer-Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 23903, United States

Location

Mary Black Memorial Hospital

Spartanburg, South Carolina, 29307, United States

Location

Baptist Memorial Hospital Memphis

Memphis, Tennessee, United States

Location

The West Cancer Clinic

Memphis, Tennessee, United States

Location

Northwest Texas Healthcare System

Amarillo, Texas, 79106, United States

Location

The Methodist Hospital

Houston, Texas, 77030, United States

Location

Scott & White Memorial Hospital & Clinic

Temple, Texas, 76508, United States

Location

The University of Texas Health Center at Tyler

Tyler, Texas, 75708, United States

Location

University Hospital

Salt Lake City, Utah, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

MedSource, Inc.

Chesapeake, Virginia, United States

Location

Portsmouth Pulmonary Associates

Chesapeake, Virginia, United States

Location

Pulmonary Associates of Fredericksburg, Inc.

Fredericksburg, Virginia, United States

Location

Maryview Medical Center

Portsmouth, Virginia, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99220, United States

Location

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Box Hill, Clayton, Garran, Kogarah, Ringwood East, Australia

Location

Unknown Facility

Saint Leonards, South Australia, Australia

Location

Unknown Facility

Graz, Austria

Location

Unknown Facility

Bruxelles, Charleroi, Leuven, Liege, Yvoir, Belgium

Location

Unknown Facility

Goiania, Porto Alegre, Sao Paulo, Salvador, Brazil

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Kelowna General Hospital

Kelowna, British Columbia, V1Y 1T2, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

QEII Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Hamilton Health Sciences - General Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

University Health Network, Toronto General Hospital

Toronto, Ontario, Canada

Location

Humber River Regional Hospital

Weston, Ontario, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Hotel-Dieu de St-Jerome

Saint-Jérôme, Quebec, Canada

Location

Unknown Facility

Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague, Czechia

Location

Unknown Facility

Pilsen, Czechia

Location

Unknown Facility

Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense, Denmark

Location

Unknown Facility

Roskilde, Denmark

Location

Unknown Facility

Hus, Jyvaskyla, Seinajoki, Turku, Finland

Location

Unknown Facility

Armentieres, Besancon, Bethune, Brest, Chambray Les Tours, France

Location

Unknown Facility

Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix, France

Location

Unknown Facility

Saint Malo, Valenciennes, France

Location

Unknown Facility

Tourcoing, France

Location

Unknown Facility

Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen, Germany

Location

Unknown Facility

Heidelberg, Ibbenburen, Mannheim, Munchen, Germany

Location

Unknown Facility

Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia, Italy

Location

Unknown Facility

Piacenza, Pisa, Reggio Emilia, Treviso, Venezia, Italy

Location

Unknown Facility

Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen, Netherlands

Location

Unknown Facility

Haarlem, Maastricht, Nieuwegein, Netherlands

Location

Unknown Facility

Oslo, Rud, Norway

Location

Unknown Facility

Lublin, Warszawa, Wroclaw, Poland

Location

Unknown Facility

Badalona, Madrid, Sevilla, Spain

Location

Unknown Facility

Goteborg, Jonkoping, Stockholm, Varnamo, Sweden

Location

Unknown Facility

Basel, Bern, Lugano, Switzerland

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (2)

• Prins MH, Guillemin I, Gilet H, Gabriel S, Essers B, Raskob G, Kahn SR. Scoring and psychometric validation of the Perception of Anticoagulant Treatment Questionnaire (PACT-Q). Health Qual Life Outcomes. 2009 Apr 7;7:30. doi: 10.1186/1477-7525-7-30.

  PMID: 19348685 DERIVED

• van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Idraparinux versus standard therapy for venous thromboembolic disease. N Engl J Med. 2007 Sep 13;357(11):1094-104. doi: 10.1056/NEJMoa064247.

  PMID: 17855670 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

idraparinux; Dalteparin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 16, 2003
• First Posted: June 17, 2003
• Study Start: June 1, 2003
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

PL (1); CA (12); NO (1); DE (2); BE (1); NL (2); SE (1); FI (1); AR (1); DK (2); AU (1); CH (1); GB (1); IT (2); US (54); CZ (2); FR (4); BR (1); ES (1)