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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 MedicineNew York, New York  10029
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Henry Ford HospitalDetroit, Michigan  48202
Akron General Medical CenterAkron, Ohio  44302
Lehigh Valley HospitalAllentown, Pennsylvania  18103
Boston Medical CenterBoston, Massachusetts  02118
Baystate Medical CenterSpringfield, Massachusetts  01199
William Beaumont HospitalRoyal Oak, Michigan  48073
Winthrop University HospitalMineola, New York  11501
Holmes Regional Medical CenterMelbourne, Florida  32901-3276
Jackson Memorial HospitalMiami, Florida  33136
Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Medical College of GeorgiaAugusta, Georgia  30912
Crozer-Chester Medical CenterUpland, Pennsylvania  19013
Swedish Medical CenterSeattle, Washington  98122-4307
University of Colorado HospitalDenver, Colorado  80262
Riverside Methodist HospitalColumbus, Ohio  43214
Bay Pines VA Medical CenterSt. Petersburg, Florida  33744
University of California, San Diego Medical CenterSan Diego, California  
Sacred Heart Medical CenterSpokane, Washington  99204
The Methodist HospitalHouston, Texas  77030
The West Cancer ClinicMemphis, Tennessee  38120
Jerry L. Pettic VA Medical CenterLoma Linda, California  
Anschutz Cancer PavilionAurora, Colorado  
Brandon Regional HospitalBrandon, Florida  33511
St. Joseph's HospitalTampa, Florida  33607
DeKalb Medical CenterDecatur, Georgia  30033
Loyola University Medical Center and Outpatient ClinicMaywood, Illinois  60153
Olathe Medical CenterOlathe, Kansas  
Christus St. Patrick HospitalLake Charles, Louisiana  70601
St. Joseph Mercy - OaklandPontiac, Michigan  48341
Lovelace Health Systems, Clinical Thrombosis CenterAlbuquerque, New Mexico  87108
Winthrop Pulmonary AssociatesMineola, New York  11501
St. Luke's-Roosevelt Hospital CenterNew York, New York  
University of North Carolina HospitalsChapel Hill, North Carolina  27599
Altru Health System HospitalGrand Forks, North Dakota  58201
Medical College of OhioToledo, Ohio  43614
INTEGRIS Southwest Medical CenterOklahoma City, Oklahoma  73109
Saint Anthony HospitalOklahoma City, Oklahoma  73101
OU Medical CenterOklahoma City, Oklahoma  73104
Oklahoma City VA Medical CenterOklahoma City, Oklahoma  73104
Mary Black Memorial HospitalSpartanburg, South Carolina  29307
Baptist Memorial Hospital MemphisMemphis, Tennessee  
Northwest Texas Healthcare SystemAmarillo, Texas  79106
Scott & White Memorial Hospital & ClinicTemple, Texas  76508
The University of Texas Health Center at TylerTyler, Texas  75708
University HospitalSalt Lake City, Utah  
Inova Alexandria HospitalAlexandria, Virginia  22304
MedSource, Inc.Chesapeake, Virginia  
Portsmouth Pulmonary AssociatesChesapeake, Virginia  
Pulmonary Associates of Fredericksburg, Inc.Fredericksburg, Virginia  
Maryview Medical CenterPortsmouth, Virginia  
McGuire VA Medical CenterRichmond, Virginia  23249