Pulmonary EmbolismPhase 3NCT00062803
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
A Phase 3 study testing SR34006, (LMW)heparin and Warfarin VKA in people with Pulmonary Embolism, run by Sanofi at 93 sites in 20 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- SR34006, (LMW)heparin and Warfarin VKA
- How many people
- Not given
- Where
- 93 sitesin 20 countries
- Study dates
- Jun 2003to Oct 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
- Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
- Written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
93 sites in 20 countries.
93 sites in 20 countries
United States54 sites
Akron General Medical Center
Akron, Ohio, 44307
Lovelace Health Systems, Clinical Thrombosis Center
Albuquerque, New Mexico, 87108
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Northwest Texas Healthcare System
Amarillo, Texas, 79106
Medical College of Georgia
Augusta, Georgia, 30912
Anschutz Cancer Pavilion
Aurora, Colorado
Sinai Hospital of Baltimore
Baltimore, Maryland
Bay Pines VA Medical Center
Bay Pines, Florida, 33744
Boston Medical Center
Boston, Massachusetts
Brandon Regional Hospital
Brandon, Florida, 33511
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
MedSource, Inc.
Chesapeake, Virginia
Portsmouth Pulmonary Associates
Chesapeake, Virginia
Riverside Methodist Hospital
Columbus, Ohio, 43214
DeKalb Medical Center
Decatur, Georgia, 30033
University of Colorado Hospital
Denver, Colorado
Henry Ford Hospital
Detroit, Michigan, 48202
Pulmonary Associates of Fredericksburg, Inc.
Fredericksburg, Virginia
Altru Health System Hospital
Grand Forks, North Dakota, 58201
The Methodist Hospital
Houston, Texas, 77030
Christus St. Patrick Hospital
Lake Charles, Louisiana, 70601
Jerry L. Pettic VA Medical Center
Loma Linda, California
Loyola University Medical Center and Outpatient Clinic
Maywood, Illinois, 60153
Holmes Regional Medical Center
Melbourne, Florida, 32901
Baptist Memorial Hospital Memphis
Memphis, Tennessee
The West Cancer Clinic
Memphis, Tennessee
Jackson Memorial Hospital
Miami, Florida, 33136
Winthrop Pulmonary Associates
Mineola, New York, 11501
Winthrop University Hospital
Mineola, New York, 11501
Mount Sinai School of Medicine
New York, New York
St. Luke's-Roosevelt Hospital Center
New York, New York
Saint Anthony Hospital
Oklahoma City, Oklahoma, 73101
Oklahoma City VA Medical Center
Oklahoma City, Oklahoma, 73104
OU Medical Center
Oklahoma City, Oklahoma, 73104
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, 73109
Olathe Medical Center
Olathe, Kansas
St. Joseph Mercy - Oakland
Pontiac, Michigan, 48341
Maryview Medical Center
Portsmouth, Virginia
McGuire VA Medical Center
Richmond, Virginia, 23249
William Beaumont Hospital
Royal Oak, Michigan, 48073
University Hospital
Salt Lake City, Utah
University of California, San Diego Medical Center
San Diego, California
Swedish Medical Center
Seattle, Washington, 98122
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 23903
Mary Black Memorial Hospital
Spartanburg, South Carolina, 29307
Sacred Heart Medical Center
Spokane, Washington, 99220
Baystate Medical Center
Springfield, Massachusetts, 01199
St. Joseph's Hospital
Tampa, Florida, 33607
Scott & White Memorial Hospital & Clinic
Temple, Texas, 76508
Medical College of Ohio
Toledo, Ohio, 43614
William Beaumont Hospital
Troy, Michigan, 48085
The University of Texas Health Center at Tyler
Tyler, Texas, 75708
Crozer-Chester Medical Center
Upland, Pennsylvania, 19013
Canada12 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 2Y9
Hamilton Health Sciences - General Hospital
Hamilton, Ontario
Kelowna General Hospital
Kelowna, British Columbia, V1Y 1T2
London Health Sciences Centre
London, Ontario, N6A 4G5
Jewish General Hospital
Montreal, Quebec
Ottawa Hospital - Civic Campus
Ottawa, Ontario, K1Y 4E9
Hotel-Dieu de St-Jerome
Saint-Jérôme, Quebec
University Health Network, Toronto General Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
Humber River Regional Hospital
Weston, Ontario
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
France4 sites
Study site
Armentieres, Besancon, Bethune, Brest, Chambray Les Tours
Study site
Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix
Study site
Saint Malo, Valenciennes
Study site
Tourcoing
Australia2 sites
Study site
Box Hill, Clayton, Garran, Kogarah, Ringwood East
Study site
Saint Leonards, South Australia
Czechia2 sites
Study site
Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague
Study site
Pilsen
Denmark2 sites
Study site
Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense
Study site
Roskilde
Germany2 sites
Study site
Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen
Study site
Heidelberg, Ibbenburen, Mannheim, Munchen
Italy2 sites
Study site
Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia
Study site
Piacenza, Pisa, Reggio Emilia, Treviso, Venezia
Netherlands2 sites
Study site
Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen
Study site
Haarlem, Maastricht, Nieuwegein
About this study
Official title: 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.
- Conditions
- Pulmonary Embolism
- Being tested
- SR34006, (LMW)heparin, Warfarin VKA, Acenocoumarol VKA
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR34006Drug
(LMW)heparinDrug
Warfarin VKADrug
Acenocoumarol VKADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Secondary outcomes (1)
symptomatic recurrent PE/DVT within 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2003 (estimated)
- Study startJun 2003
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
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
- NCT00062803
- Sponsor's protocol ID
- EFC3484
- Status last verified
- Apr 2009
- First submitted
- 16 Jun 2003
- Last updated
- 29 Apr 2009
- Results posted
- No
Publications
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.
PubMed 19348685van 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.
PubMed 17855670
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00062803
- Acronym / sponsor ID
- EFC3484
- Conditions
- Pulmonary Embolism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 17 Jun 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep Vein Thrombosis (DVT)
- Written informed consent
Key exclusion criteria (11 listed)
- 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
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 | Drug | – |
| (LMW)heparin | Drug | – |
| Warfarin VKA | Drug | – |
| Acenocoumarol VKA | Drug | – |
Primary outcome
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
1 secondary outcome
symptomatic recurrent PE/DVT within 6 months.
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 29 Apr 2009.
- Derived from this study: PubMed 19348685Prins 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.
- Derived from this study: PubMed 17855670van 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.
- Related InfoLink provided by the sponsor.
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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
93 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, (LMW)heparin and Warfarin VKA in people with Pulmonary Embolism, run by Sanofi at 93 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 11 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 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 93 sites in United States, Canada, France, Australia, 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 pulmonary embolism or deep vein thrombosis within 3 months.. 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 NCT00062803, which also lists 2 linked publications.
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 29 Apr 2009.