Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00067093

Purpose

Patients who have deep vein thrombosis (blood clot in the leg) 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 administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Condition	Intervention	Phase
Deep Vein Thrombosis	Drug: SanOrg34006 Drug: LMW heparin Drug: Unfractionated heparin Drug: Vitamin K antagonist (VKA)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis Vitamin K

Drug Information available for: Vitamin K SR 34006 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.

Enrollment:	1452
Study Start Date:	May 2003
Study Completion Date:	September 2005
Primary Completion Date:	September 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 DVT
Written informed consent

Exclusion Criteria:

Legal lower age limitations
Patients with symptomatic pulmonary embolism
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
Other indication for VKA than DVT
More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
Participation in another pharmacotherapeutic study within the prior 30 days
Creatinine clearance <10mL/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 and diastolic blood pressure >110 mm Hg.
Pregnancy or childbearing potential without proper contraceptive measures
Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067093

Show 24 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 ClinicalTrials.gov Identifier (NCT Number):

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:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00067093 History of Changes
Other Study ID Numbers:	EFC3491, SR34006
Study First Received:	August 11, 2003
Last Updated:	April 5, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Calcium heparin
Heparin
Vitamin K
Vitamins
Anticoagulants
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on February 12, 2012