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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Pulmonary Embolism

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC3484

NCT ID:

NCT00062803

Start Date:

June 2003

Completion Date:

October 2005

Related Keywords:

  • Pulmonary Embolism
  • Embolism
  • Pulmonary Embolism

Name

Location

Mount Sinai School of Medicine New York, New York  10029
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Henry Ford Hospital Detroit, Michigan  48202
Akron General Medical Center Akron, Ohio  44302
Lehigh Valley Hospital Allentown, Pennsylvania  18103
Boston Medical Center Boston, Massachusetts  02118
Baystate Medical Center Springfield, Massachusetts  01199
William Beaumont Hospital Royal Oak, Michigan  48073
Winthrop University Hospital Mineola, New York  11501
Holmes Regional Medical Center Melbourne, Florida  32901-3276
Jackson Memorial Hospital Miami, Florida  33136
Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Medical College of Georgia Augusta, Georgia  30912
Crozer-Chester Medical Center Upland, Pennsylvania  19013
Swedish Medical Center Seattle, Washington  98122-4307
University of Colorado Hospital Denver, Colorado  80262
Riverside Methodist Hospital Columbus, Ohio  43214
Bay Pines VA Medical Center St. Petersburg, Florida  33744
University of California, San Diego Medical Center San Diego, California  
Sacred Heart Medical Center Spokane, Washington  99204
The Methodist Hospital Houston, Texas  77030
The West Cancer Clinic Memphis, Tennessee  38120
Jerry L. Pettic VA Medical Center Loma Linda, California  
Anschutz Cancer Pavilion Aurora, Colorado  
Brandon Regional Hospital Brandon, Florida  33511
St. Joseph's Hospital Tampa, Florida  33607
DeKalb Medical Center Decatur, Georgia  30033
Loyola University Medical Center and Outpatient Clinic Maywood, Illinois  60153
Olathe Medical Center Olathe, Kansas  
Christus St. Patrick Hospital Lake Charles, Louisiana  70601
St. Joseph Mercy - Oakland Pontiac, Michigan  48341
Lovelace Health Systems, Clinical Thrombosis Center Albuquerque, New Mexico  87108
Winthrop Pulmonary Associates Mineola, New York  11501
St. Luke's-Roosevelt Hospital Center New York, New York  
University of North Carolina Hospitals Chapel Hill, North Carolina  27599
Altru Health System Hospital Grand Forks, North Dakota  58201
Medical College of Ohio Toledo, Ohio  43614
INTEGRIS Southwest Medical Center Oklahoma City, Oklahoma  73109
Saint Anthony Hospital Oklahoma City, Oklahoma  73101
OU Medical Center Oklahoma City, Oklahoma  73104
Oklahoma City VA Medical Center Oklahoma City, Oklahoma  73104
Mary Black Memorial Hospital Spartanburg, South Carolina  29307
Baptist Memorial Hospital Memphis Memphis, Tennessee  
Northwest Texas Healthcare System Amarillo, Texas  79106
Scott & White Memorial Hospital & Clinic Temple, Texas  76508
The University of Texas Health Center at Tyler Tyler, Texas  75708
University Hospital Salt Lake City, Utah  
Inova Alexandria Hospital Alexandria, Virginia  22304
MedSource, Inc. Chesapeake, Virginia  
Portsmouth Pulmonary Associates Chesapeake, Virginia  
Pulmonary Associates of Fredericksburg, Inc. Fredericksburg, Virginia  
Maryview Medical Center Portsmouth, Virginia  
McGuire VA Medical Center Richmond, Virginia  23249