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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SR34006 | Drug | |||
| (LMW)heparin | Drug | |||
| Warfarin VKA | Drug | |||
| Acenocoumarol VKA | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| symptomatic recurrent PE/DVT within 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jerry L. Pettic VA Medical Center | Loma Linda | California | United States | |||
| University of California, San Diego Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19348685 | Derived | 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. | |
| 17855670 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| San Diego |
| California |
| United States |
| Anschutz Cancer Pavilion | Aurora | Colorado | United States |
| University of Colorado Hospital | Denver | Colorado | United States |
| Bay Pines VA Medical Center | Bay Pines | Florida | 33744 | United States |
| Brandon Regional Hospital | Brandon | Florida | 33511 | United States |
| Holmes Regional Medical Center | Melbourne | Florida | 32901 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| St. Joseph's Hospital | Tampa | Florida | 33607 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| DeKalb Medical Center | Decatur | Georgia | 30033 | United States |
| Loyola University Medical Center and Outpatient Clinic | Maywood | Illinois | 60153 | United States |
| Olathe Medical Center | Olathe | Kansas | United States |
| Christus St. Patrick Hospital | Lake Charles | Louisiana | 70601 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | United States |
| Boston Medical Center | Boston | Massachusetts | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| St. Joseph Mercy - Oakland | Pontiac | Michigan | 48341 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Lovelace Health Systems, Clinical Thrombosis Center | Albuquerque | New Mexico | 87108 | United States |
| Winthrop Pulmonary Associates | Mineola | New York | 11501 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| Mount Sinai School of Medicine | New York | New York | United States |
| St. Luke's-Roosevelt Hospital Center | New York | New York | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| Altru Health System Hospital | Grand Forks | North Dakota | 58201 | United States |
| Akron General Medical Center | Akron | Ohio | 44307 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Medical College of Ohio | Toledo | Ohio | 43614 | United States |
| Saint Anthony Hospital | Oklahoma City | Oklahoma | 73101 | United States |
| Oklahoma City VA Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| OU Medical Center | Oklahoma City | Oklahoma | 73104 | United States |
| INTEGRIS Southwest Medical Center | Oklahoma City | Oklahoma | 73109 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18105 | United States |
| Crozer-Chester Medical Center | Upland | Pennsylvania | 19013 | United States |
| Spartanburg Regional Medical Center | Spartanburg | South Carolina | 23903 | United States |
| Mary Black Memorial Hospital | Spartanburg | South Carolina | 29307 | United States |
| Baptist Memorial Hospital Memphis | Memphis | Tennessee | United States |
| The West Cancer Clinic | Memphis | Tennessee | United States |
| Northwest Texas Healthcare System | Amarillo | Texas | 79106 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Scott & White Memorial Hospital & Clinic | Temple | Texas | 76508 | United States |
| The University of Texas Health Center at Tyler | Tyler | Texas | 75708 | United States |
| University Hospital | Salt Lake City | Utah | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| MedSource, Inc. | Chesapeake | Virginia | United States |
| Portsmouth Pulmonary Associates | Chesapeake | Virginia | United States |
| Pulmonary Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | United States |
| Maryview Medical Center | Portsmouth | Virginia | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Sacred Heart Medical Center | Spokane | Washington | 99220 | United States |
| Buenos Aires | Argentina |
| Box Hill, Clayton, Garran, Kogarah, Ringwood East | Australia |
| Saint Leonards, South Australia | Australia |
| Graz | Austria |
| Bruxelles, Charleroi, Leuven, Liege, Yvoir | Belgium |
| Goiania, Porto Alegre, Sao Paulo, Salvador | Brazil |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Kelowna General Hospital | Kelowna | British Columbia | V1Y 1T2 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| QEII Health Sciences Center | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Hamilton Health Sciences - General Hospital | Hamilton | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | N6A 4G5 | Canada |
| Ottawa Hospital - Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| University Health Network, Toronto General Hospital | Toronto | Ontario | Canada |
| Humber River Regional Hospital | Weston | Ontario | Canada |
| Jewish General Hospital | Montreal | Quebec | Canada |
| Hotel-Dieu de St-Jerome | Saint-Jérôme | Quebec | Canada |
| Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague | Czechia |
| Pilsen | Czechia |
| Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense | Denmark |
| Roskilde | Denmark |
| Hus, Jyvaskyla, Seinajoki, Turku | Finland |
| Armentieres, Besancon, Bethune, Brest, Chambray Les Tours | France |
| Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix | France |
| Saint Malo, Valenciennes | France |
| Tourcoing | France |
| Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen | Germany |
| Heidelberg, Ibbenburen, Mannheim, Munchen | Germany |
| Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia | Italy |
| Piacenza, Pisa, Reggio Emilia, Treviso, Venezia | Italy |
| Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen | Netherlands |
| Haarlem, Maastricht, Nieuwegein | Netherlands |
| Oslo, Rud | Norway |
| Lublin, Warszawa, Wroclaw | Poland |
| Badalona, Madrid, Sevilla | Spain |
| Goteborg, Jonkoping, Stockholm, Varnamo | Sweden |
| Basel, Bern, Lugano | Switzerland |
| London | United Kingdom |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C479958 | idraparinux |
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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