Clinical trial NCT00067093: Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2003-08-13
Enrollment: 1452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
Secondary outcomes:
measure: symptomatic recurrent PE/DVT within 6 months.
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Jacksonville
country: United States
facility: Jackson Cardio-Vascular Clinic
state: Florida
city: Melbourne
country: United States
facility: MIMA Century Research Associates
state: Florida
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Decatur
country: United States
facility: DeKalb Medical Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Maywood
country: United States
facility: Loyola University of Chicago
state: Illinois
city: Olathe
country: United States
facility: Consultants in Pulmonary Medicine
state: Kansas
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Pontiac
country: United States
facility: St. Joseph Mercy - Oakland Research Center
state: Michigan
city: Albuquerque
country: United States
facility: Lovelace Health Systems
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Grand Forks
country: United States
facility: Health System Research Center
state: North Dakota
city: Oklahoma City
country: United States
facility: University of Oklahoma HSC
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Houston
country: United States
facility: James Muntz
state: Texas
city: Temple
country: United States
facility: Scott and White Memorial Hospital & Clinic
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Fredericksburg
country: United States
facility: Pulmonary Associates
state: Virginia
city: Richmond
country: United States
facility: McGuire VAMC
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: William Dittman
state: Washington
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1186/1477-7525-7-30.
citation: 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. doi: 10.1056/NEJMoa064247.