Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CV1/01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| LEO Pharma | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
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 a similar period of time in patients with proximal venous thrombosis.
Not provided
Not provided
Not provided
Not provided
| 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 for 1 weeks 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 |
|---|---|---|
| Incidence of symptomatic recurrent venous thromboembolism | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of major bleeding | 6 month treatment interval |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Antoni Romera, MD | Hospital Universitari de Bellvitge | Study Chair |
| Antoni Romera, MD | Hospital Universitari de Bellvitge | Principal Investigator |
| Oriol Lapiedra, MD | Hospital Creu Roja de l'Hospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular surgery service. Hospital Creu Roja de l'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08906 | Spain | ||
Not provided
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078222 | Tinzaparin |
| D000074 | Acenocoumarol |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| acenocoumarol | Drug | tinzaparin subcutaneously 175 IU anti-Xa/kg of body weight once daily for 7 days followed by acenocoumarol for 6 months |
|
|
| Department of Vascular Surgery. Hospital Universitari de Bellvitge |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| 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 |