SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00062803

Purpose

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.

Condition	Intervention	Phase
Pulmonary Embolism	Drug: SR34006 Drug: (LMW)heparin Drug: Warfarin VKA Drug: Acenocoumarol VKA	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Pulmonary Embolism

Drug Information available for: Vitamin K Warfarin SR 34006 Acenocoumarol Heparin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

symptomatic recurrent PE/DVT within 6 months.

Study Start Date:	June 2003
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062803

Show 93 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Sanofi-Aventis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

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.

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC3484
Study First Received:	June 16, 2003
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00062803 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pulmonary Embolism
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents

Embolism and Thrombosis
Respiratory Tract Diseases
Embolism
Lung Diseases
Acenocoumarol
Therapeutic Uses
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on November 27, 2009