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| ID | Type | Description | Link |
|---|---|---|---|
| SR34006 |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SanOrg34006 | Drug | |||
| LMW heparin | Drug | |||
| Unfractionated heparin | Drug | |||
| Vitamin K antagonist (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 |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Denver | Colorado | 80129 | United States | ||
| Jackson Cardio-Vascular Clinic |
| 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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| Jacksonville |
| Florida |
| 32216 |
| United States |
| MIMA Century Research Associates | Melbourne | Florida | 32901 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| DeKalb Medical Center | Decatur | Georgia | 30033-6136 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Evanston Northwestern Healthcare | Evanston | Illinois | 60201 | United States |
| Loyola University of Chicago | Maywood | Illinois | 60513 | United States |
| Consultants in Pulmonary Medicine | Olathe | Kansas | 66061 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| St. Joseph Mercy - Oakland Research Center | Pontiac | Michigan | 48341 | United States |
| Lovelace Health Systems | Albuquerque | New Mexico | 87108 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Health System Research Center | Grand Forks | North Dakota | 58201 | United States |
| University of Oklahoma HSC | Oklahoma City | Oklahoma | 73104 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| James Muntz | Houston | Texas | 77030 | United States |
| Scott and White Memorial Hospital & Clinic | Temple | Texas | 76508 | United States |
| Inova Alexandria Hospital | Alexandria | Virginia | 22304 | United States |
| Pulmonary Associates | Fredericksburg | Virginia | 22401 | United States |
| McGuire VAMC | Richmond | Virginia | 23249 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| William Dittman | Spokane | Washington | 99203 | United States |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C479958 | idraparinux |
| D017985 | Dalteparin |
| D006493 | Heparin |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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