| June 16, 2003 |
| April 28, 2009 |
| June 2003 |
| October 2005 (final data collection date for primary outcome measure) |
| symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months. |
| Same as current |
| Complete list of historical versions of study NCT00062803 on ClinicalTrials.gov Archive Site |
| symptomatic recurrent PE/DVT within 6 months. |
| Same as current |
| |
| SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism |
| 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 |
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. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Safety/Efficacy Study |
| Pulmonary Embolism |
- Drug: SR34006
- Drug: (LMW)heparin
- Drug: Warfarin VKA
- Drug: Acenocoumarol VKA
|
| |
- 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.
|
| |
| Completed |
|
| October 2005 |
| October 2005 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom |
| |
| NCT00062803 |
| ICD Study Director, sanofi-aventis |
| EFC3484 |
| Sanofi-Aventis |
|
| Study Director: |
ICD CSD |
Sanofi-Aventis |
|
|
| Sanofi-Aventis |
| April 2009 |
