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

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SR34006
(LMW)heparin
Warfarin VKA
Acenocoumarol VKA
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jerry L. Pettic VA Medical Center
  • University of California, San Diego Medical Center
  • Anschutz Cancer Pavilion
  • University of Colorado Hospital
  • Bay Pines VA Medical Center
  • Brandon Regional Hospital
  • Holmes Regional Medical Center
  • Jackson Memorial Hospital
  • St. Joseph's Hospital
  • Medical College of Georgia
  • DeKalb Medical Center
  • Loyola University Medical Center and Outpatient Clinic
  • Olathe Medical Center
  • Christus St. Patrick Hospital
  • Sinai Hospital of Baltimore
  • Boston Medical Center
  • Baystate Medical Center
  • Henry Ford Hospital
  • St. Joseph Mercy - Oakland
  • William Beaumont Hospital
  • William Beaumont Hospital
  • Lovelace Health Systems, Clinical Thrombosis Center
  • Winthrop Pulmonary Associates
  • Winthrop University Hospital
  • Mount Sinai School of Medicine
  • St. Luke's-Roosevelt Hospital Center
  • University of North Carolina Hospitals
  • Altru Health System Hospital
  • Akron General Medical Center
  • Riverside Methodist Hospital
  • Medical College of Ohio
  • Saint Anthony Hospital
  • Oklahoma City VA Medical Center
  • OU Medical Center
  • INTEGRIS Southwest Medical Center
  • Lehigh Valley Hospital
  • Crozer-Chester Medical Center
  • Spartanburg Regional Medical Center
  • Mary Black Memorial Hospital
  • Baptist Memorial Hospital Memphis
  • The West Cancer Clinic
  • Northwest Texas Healthcare System
  • The Methodist Hospital
  • Scott & White Memorial Hospital & Clinic
  • The University of Texas Health Center at Tyler
  • University Hospital
  • Inova Alexandria Hospital
  • MedSource, Inc.
  • Portsmouth Pulmonary Associates
  • Pulmonary Associates of Fredericksburg, Inc.
  • Maryview Medical Center
  • McGuire VA Medical Center
  • Swedish Medical Center
  • Sacred Heart Medical Center
  • University of Alberta Hospital
  • Kelowna General Hospital
  • St. Paul's Hospital
  • St. Boniface General Hospital
  • QEII Health Sciences Center
  • Hamilton Health Sciences - General Hospital
  • London Health Sciences Centre
  • Ottawa Hospital - Civic Campus
  • University Health Network, Toronto General Hospital
  • Humber River Regional Hospital
  • Jewish General Hospital
  • Hotel-Dieu de St-Jerome

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

symptomatic recurrent PE/DVT within 6 months.

Full Information

First Posted
June 16, 2003
Last Updated
April 28, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00062803
Brief Title
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SR34006
Intervention Type
Drug
Intervention Name(s)
(LMW)heparin
Intervention Type
Drug
Intervention Name(s)
Warfarin VKA
Intervention Type
Drug
Intervention Name(s)
Acenocoumarol VKA
Primary Outcome Measure Information:
Title
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary Outcome Measure Information:
Title
symptomatic recurrent PE/DVT within 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Jerry L. Pettic VA Medical Center
City
Loma Linda
State/Province
California
Country
United States
Facility Name
University of California, San Diego Medical Center
City
San Diego
State/Province
California
Country
United States
Facility Name
Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
Country
United States
Facility Name
University of Colorado Hospital
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Bay Pines VA Medical Center
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Facility Name
Brandon Regional Hospital
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Holmes Regional Medical Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Loyola University Medical Center and Outpatient Clinic
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Olathe Medical Center
City
Olathe
State/Province
Kansas
Country
United States
Facility Name
Christus St. Patrick Hospital
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Joseph Mercy - Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Lovelace Health Systems, Clinical Thrombosis Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Winthrop Pulmonary Associates
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
Country
United States
Facility Name
University of North Carolina Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Altru Health System Hospital
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Medical College of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Saint Anthony Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73101
Country
United States
Facility Name
Oklahoma City VA Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
OU Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
INTEGRIS Southwest Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Crozer-Chester Medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
23903
Country
United States
Facility Name
Mary Black Memorial Hospital
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29307
Country
United States
Facility Name
Baptist Memorial Hospital Memphis
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
The West Cancer Clinic
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Northwest Texas Healthcare System
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Memorial Hospital & Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
The University of Texas Health Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
University Hospital
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Inova Alexandria Hospital
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
MedSource, Inc.
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Portsmouth Pulmonary Associates
City
Chesapeake
State/Province
Virginia
Country
United States
Facility Name
Pulmonary Associates of Fredericksburg, Inc.
City
Fredericksburg
State/Province
Virginia
Country
United States
Facility Name
Maryview Medical Center
City
Portsmouth
State/Province
Virginia
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
City
Buenos Aires
Country
Argentina
City
Box Hill, Clayton, Garran, Kogarah, Ringwood East
Country
Australia
City
St. Leonards, South Australia
Country
Australia
City
Graz
Country
Austria
City
Bruxelles, Charleroi, Leuven, Liege, Yvoir
Country
Belgium
City
Goiania, Porto Alegre, Sao Paulo, Salvador
Country
Brazil
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Kelowna General Hospital
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1T2
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
St. Boniface General Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
QEII Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Hamilton Health Sciences - General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Humber River Regional Hospital
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hotel-Dieu de St-Jerome
City
St-Jerome
State/Province
Quebec
Country
Canada
City
Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague
Country
Czech Republic
City
Plzen
Country
Czech Republic
City
Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense
Country
Denmark
City
Roskilde
Country
Denmark
City
Hus, Jyvaskyla, Seinajoki, Turku
Country
Finland
City
Armentieres, Besancon, Bethune, Brest, Chambray Les Tours
Country
France
City
Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix
Country
France
City
Saint Malo, Valenciennes
Country
France
City
Tourcoing
Country
France
City
Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen
Country
Germany
City
Heidelberg, Ibbenburen, Mannheim, Munchen
Country
Germany
City
Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia
Country
Italy
City
Piacenza, Pisa, Reggio Emilia, Treviso, Venezia
Country
Italy
City
Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen
Country
Netherlands
City
Haarlem, Maastricht, Nieuwegein
Country
Netherlands
City
Oslo, Rud
Country
Norway
City
Lublin, Warszawa, Wroclaw
Country
Poland
City
Badalona, Madrid, Sevilla
Country
Spain
City
Goteborg, Jonkoping, Stockholm, Varnamo
Country
Sweden
City
Basel, Bern, Lugano
Country
Switzerland
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19348685
Citation
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.
Results Reference
derived
PubMed Identifier
17855670
Citation
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.
Results Reference
derived
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info

Learn more about this trial

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

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