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| ID | Type | Description | Link |
|---|---|---|---|
| eudract-no. 2004-002019-97 |
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| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
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The purpose of this study is to evaluate the feasibility of the long-term treatment of pulmonary embolism with tinzaparin compared to oral anticoagulants.
The open-label prospective randomized clinical trial compares subcutaneous LMWH (tinzaparin) administered for 6 months versus initial treatment using subcutaneous LMWH followed by oral anticoagulants given for 6 months in patients with acute venous thrombosis.
To evaluate the direct and indirect cost of each treatment regimen in a rural population environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tinzaparin | Experimental | tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months |
|
| acenocoumarol | Active Comparator | tinzaparin followed by acenocoumarol for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tinzaparin | Drug | tinzaparin (innohep®)subcutaneously in a fixed dose of 175 IU anti-Xa/kg of body weight once daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the secondary prophylaxis of pulmonary embolism with tinzaparin | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| direct and indirect cost of each treatment regimen | 6 months | |
| Major haemorrhagic events | 6 months |
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Inclusion Criteria:
Symptomatic pulmonary embolism patients confirmed by:
Aged 18 years or above, of either sex
The patient must provide signed informed consent
Patients will be agreed for receiving ambulatory anticoagulant treatment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Pérez de Llano, MD | Complejo Hospitalario Xeral Calde (Lugo) | Study Chair |
| Alejandro Veres Racamonde, MD | Complejo Hospitalario Xeral Calde (Lugo) | Principal Investigator |
| Manuel Núnez Delgado, MD | Hospital do Meixoeiro (Vigo) | Principal Investigator |
| Ana Palacios Bartolomé, MD | Hospital ClÃnico de Santiago | Principal Investigator |
| Virginia Leiro Fernández, MD | Hospital Xeral (Vigo) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumology Service. Hospital ClÃnico | Santiago de Compostela | A Coruña | 15706 | Spain | ||
| Pneumology Service |
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| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
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| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| D000074 | Acenocoumarol |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| acenocoumarol | Drug | acenocoumarol for 6 months |
|
|
| Lugo |
| Lugo |
| 27004 |
| Spain |
| Pneumology Service. Hospital Xeral Cies | Vigo | Pontevedra | 36204 | Spain |
| Pneumology Service. Hospital do Meixoeiro | Vigo | Pontevedra | 36214 | Spain |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002241 |
| Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |