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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

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.

Study Start Date:

July 2003

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

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Locations

United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80129
United States, Florida
MIMA Century Research Associates
Melbourne, Florida, United States, 32901
Jackson Cardio-Vascular Clinic
Jacksonville, Florida, United States, 32216
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
DeKalb Medical Center
Decatur, Georgia, United States, 30033-6136
United States, Illinois
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
Loyola University of Chicago
Maywood, Illinois, United States, 60513
Northwestern University
Chicago, Illinois, United States, 60611
United States, Kansas
Consultants in Pulmonary Medicine
Olathe, Kansas, United States, 66061
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
St. Joseph Mercy - Oakland Research Center
Pontiac, Michigan, United States, 48341
United States, New Mexico
Lovelace Health Systems
Albuquerque, New Mexico, United States, 87108
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Dakota
Health System Research Center
Grand Forks, North Dakota, United States, 58201
United States, Oklahoma
University of Oklahoma HSC
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
United States, Texas
Scott and White Memorial Hospital & Clinic
Temple, Texas, United States, 76508
James Muntz
Houston, Texas, United States, 77030
United States, Virginia
McGuire VAMC
Richmond, Virginia, United States, 23249
Pulmonary Associates
Fredericksburg, Virginia, United States, 22401
Inova Alexandria Hospital
Alexandria, Virginia, United States, 22304
United States, Washington
William Dittman
Spokane, Washington, United States, 99203
Swedish Medical Center
Seattle, Washington, United States, 98122

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:	EFC3491, SR34006
Study First Received:	August 11, 2003
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00067093 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Heparin, Low-Molecular-Weight
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis

Pharmacologic Actions
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Venous Thrombosis
Cardiovascular Diseases
Heparin

ClinicalTrials.gov processed this record on November 27, 2009