Pulmonary EmbolismPhase 3NCT00071279
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
A Phase 3 study testing SR34006 (idraparinux sodium) Injection in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Sanofi at 65 sites in 20 countries.
Trial summary
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Vein Thrombosis
- What is being tested?
- SR34006 (idraparinux sodium) Injection
- Type of treatment
- Injection or infusion
- How many people
- 1,215 participants
- Where
- 65 sitesin 20 countries
- Study dates
- Nov 2003to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
- Written informed consent
Who cannot join
- Legal age limitations (country specific)
- Indication for anticoagulation other than PE or DVT
- Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis
- Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
- Life expectancy <3 months
- Patients in whom anticoagulation treatment for their index PE or DVT should be continued beyond 6 months
Show all 9Show fewer
- 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, women who are breastfeeding.
Trial locations and contacts
65 sites in 20 countries.
65 sites in 20 countries
United States32 sites
Lovelace Sandia Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico
University of New Mexico Hospital
Albuquerque, New Mexico
Inova Alexandria Hospital
Alexandria, Virginia
Lehigh Valley Hospital
Allentown, Pennsylvania
Medical College of Georgia
Augusta, Georgia
Sinai Hospital of Baltimore
Baltimore, Maryland
Bay Pines VA Medical Center
Bay Pines, Florida
Dr. Kiritkumar C. Patel's and Dr. Michele DeGregorio's Office
Bloomfield Hills, Michigan
Pulmonary Associates of Brandon
Brandon, Florida
Henry Ford Hospital
Detroit, Michigan
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia
The Methodist Hospital
Houston, Texas
Jacksonville Cardiovascular Clinic
Jacksonville, Florida
Cardinal Bernardin Cancer Center
Maywood, Illinois
Loyola University Medical Center
Maywood, Illinois
Melbourne Internal Medicine Associates (MIMA)
Melbourne, Florida
Melbourne Internal Medical Associates (MIMA)
Palm Bay, Florida
St. Joseph Mercy - Oakland Clinical Research Office
Pontiac, Michigan
St. Joseph Mercy - Oakland
Pontiac, Michigan
McGuire VA Medical Center
Richmond, Virginia
William Beaumont Hospital / Clinical Research Center
Royal Oak, Michigan
Swedish Medical Center
Seattle, Washington
Lung & Chest Medical Associates
Spartanburg, South Carolina
Spartanburg Pharmaceutical Research
Spartanburg, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina
Pulmonary Specialists/Spokane Respiratory Consultants
Spokane, Washington
Sacred Heart Medical Center
Spokane, Washington
Clinical Pharmacology Services
Tampa, Florida
Scott and White Memorial Hospital and Clinic
Temple, Texas
William Beaumont Hospital Troy
Troy, Michigan
The University of Texas Health Center at Tyler
Tyler, Texas
Crozer-Chester Medical Center
Upland, Pennsylvania
Canada7 sites
University of Alberta
Edmonton, Alberta
Kelowna General Hospital
Kelowna, British Columbia
Jewish General Hospital
Montreal, Quebec
The Ottawa Hospital, Civic Campus
Ottawa, Ontario
Centre hospitalier de l'Universite Laval du Centre hospitalier universitaire de Quebec
Sainte-Foy, Quebec
St. Paul's Hospital
Vancouver, British Columbia
St. Boniface General Hospital
Winnipeg, Manitoba
Australia3 sites
Study site
Box Hill, Clayton, Coffs Harbour, Garran, Kogarah
Study site
Premantle, Redcliffe, Saint Leonards, South Australia
Study site
Ringwood East, Woolloongabba
France3 sites
Study site
Besancon, Brest, Chambray Les Tours, Clamart, Grenoble
Study site
Montpellier, Paris, Rouen, Saint Brieuc, Saint Etienne
Study site
Toulouse, Valenciennes
Czechia2 sites
Study site
Brno, Hradec Karlove, Jihlava, Karlovy Vary, Kladno
Study site
Ostrava-Poruba, Plzen, Prague, Usti Nad Labem
Denmark2 sites
Study site
Arhus, Braedstrup, Frederiksberg, Glostrup, Hillerod
Study site
Kobenhavn, Odense
Italy2 sites
Study site
Genova, Milano, Padova, Parma, Pavia, Piacenza, Reggio Emilia
Study site
Treviso, Venezia
Netherlands2 sites
Study site
Alkmaar, Almere, Amersfoort, Amsterdam, Arnhem, Haarlem
Study site
Maastricht, Nieuwegein, Sittard, Zwolle
Germany1 site
Study site
Berlin, Bochum, Dresden, Heidelberg, Ibbenburen, Mannheim
About this study
Official title: The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.
In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.
Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Being tested
- SR34006 (idraparinux sodium) Injection
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR34006 (idraparinux sodium) InjectionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
Secondary outcomes (1)
Major bleeding during the 6-month study treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2003 (estimated)
- Study startNov 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 1,215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071279
- Sponsor's protocol ID
- EFC5135
- Other IDs
- SR34006
- Status last verified
- Apr 2011
- First submitted
- 16 Oct 2003
- Last updated
- 6 Apr 2011
- Results posted
- No
Publications
van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.
PubMed 17855671
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Van Gogh-extension Trial, a Multicenter, International, Randomized, Double-blind, Study Comparing the Efficacy and Safety of Once-weekly Subcutaneous SR34006 With Placebo in the Long-term Prevention of Symptomatic Venous Thromboembolism in Patients With Symptomatic Pulmonary Embolism or Deep-vein Thrombosis Who Completed 6 Months of Treatment With Vitamin K Antagonist or SR34006
- ClinicalTrials.gov ID
- NCT00071279
- Acronym / sponsor ID
- EFC5135
- Conditions
- Pulmonary Embolism, Deep Vein Thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,215 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur. Anticoagulant (blood-thinning) drugs are normally given immediately after the clot is discovered and are continued for a period of 3 or 6 months during which time the risk for recurrence is highest. Research has shown that when oral anticoagulants are used appropriately during this period, patients are less at risk for a recurrent blood clot and this risk reduction outweighs the potential for bleeding to occur.
In this study, patients who had a blood clot in the lung or in a leg vein and completed 6 months of treatment with daily oral vitamin K antagonists (acenocoumarol or warfarin) or once-weekly injections of SR34006 (a new anticoagulant drug) will receive an additional 6 months of once-weekly SR34006 injections or injections of a solution containing no drug (placebo). This trial will evaluate whether patients treated for an additional 6 months with SR34006 have fewer recurrences of blood clots when compared to patients treated with placebo.
Assignment to either SR34006 or placebo will be purely by chance. Neither the patients nor their doctors will know which treatment is being given.
Study design
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with confirmed symptomatic Pulmonary Embolism (PE) or Deep Vein Thrombosis (DVT) who have been treated with acenocoumarol, warfarin or SR34006 for six months
- Written informed consent
Key exclusion criteria (9 listed)
- Legal age limitations (country specific)
- Indication for anticoagulation other than PE or DVT
- Creatinine clearance (CLcr) <10 mL/min, severe hepatic disease, or bacterial endocarditis
- Participation in a pharmacotherapeutic study other than the Van Gogh-PE or DVT study within the prior 30 days
- Life expectancy <3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR34006 (idraparinux sodium) Injection | Drug | – |
Primary outcome
Symptomatic recurrent PE/DVT during the 6-month study treatment period.
1 secondary outcome
Major bleeding during the 6-month study treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2011.
- Derived from this study: PubMed 17855671van Gogh Investigators; Buller HR, Cohen AT, Davidson B, Decousus H, Gallus AS, Gent M, Pillion G, Piovella F, Prins MH, Raskob GE. Extended prophylaxis of venous thromboembolism with idraparinux. N Engl J Med. 2007 Sep 13;357(11):1105-12. doi: 10.1056/NEJMoa067703.
- Related InfoLink provided by the sponsor.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
65 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SR34006 (idraparinux sodium) Injection in people with Pulmonary Embolism and Deep Vein Thrombosis, run by Sanofi at 65 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Canada, Australia, France, Czechia and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic recurrent PE/DVT during the 6-month study treatment period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2011.