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 |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.
Patients with active cancer and symptomatic pulmonary embolism, proximal deep vein thrombosis, iliac or caval thrombosis will be randomly assigned to receive either dalteparin using the CLOT regimen or to oral rivaroxaban using the conventional dosage given in the Einstein studies. Experimental and control treatments will be given for three months. The main outcome at three month will include all symptomatic and incidentally discovered venous thromboembolic events including pulmonary embolism (either objectively confirmed and death due to pulmonary embolism), lower limb and upper limb deep vein thrombosis, iliac, caval and visceral thrombosis and any worsening of vascular obstruction which will be collected systematically at inclusion and at day 90. The safety end-points will consist of the rate of major bleedings and the composite of major and non-major but clinically significant bleedings at day 90. All outcome events will be blindly adjudicated by a central independent adjudication committee.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-molecular-weight heparin | Active Comparator | dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months |
|
| Rivaroxaban | Experimental | rivaroxaban, orally, 15 mg twice daily for 3 weeks followed by 20 mg once daily for 9 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivaroxaban | Drug | rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic DVT | Recurrent VTE during the 3-month treatment period including all symptomatic DVT (lower limbs distal and proximal DVTs, iliac and caval thrombosis, visceral thrombosis and deep vein thrombosis of the arm) | 3 months |
| Symptomatic PE | Recurrent VTE during the 3-month treatment period including symptomatic PE | 3 months |
| Unsuspected PE and DVT | Recurrent VTE during the 3-month treatment period including clinically unsuspected PE and DVT discovered incidentally | 3 months |
| Worsening of pulmonary vascular or venous obstruction | Recurrent VTE during the 3-month treatment period including worsening of pulmonary vascular obstruction or venous obstruction on the systematic examinations performed at the end of the 3-month treatment period | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major and clinically significant bleedings during the 3-month treatment period | Major bleeding is defined according to the International Society on Thrombosis and Haemostasis (ISTH) criteria and includes any bleeding resulting in death; symptomatic bleeding in a critical organ including intracranial, intra spinal, intraocular, retroperitoneal, intra articular and pericardial bleeding and muscle bleeding resulting in compartment syndrome; symptomatic bleeding resulting in a decrease in the hemoglobin concentration of at least 2g/dL or resulting in the transfusion of at least two packs of blood red cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Rivaroxaban plasma concentrations | Area under the plasma concentration versus time curve (AUC) determined using a liquid chromatography-tandem mass spectrometry method | 3 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guy Meyer, MD | APHP - HEGP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens - Medecine vasculaire (003) | Amiens | France | ||||
| CHU Angers - Medecin Interne (002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34627853 | Derived | Planquette B, Bertoletti L, Charles-Nelson A, Laporte S, Grange C, Mahe I, Pernod G, Elias A, Couturaud F, Falvo N, Sevestre MA, Ray V, Burnod A, Brebion N, Roy PM, Timar-David M, Aquilanti S, Constans J, Bura-Riviere A, Brisot D, Chatellier G, Sanchez O, Meyer G, Girard P, Mismetti P; CASTA DIVA Trial Investigators. Rivaroxaban vs Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial. Chest. 2022 Mar;161(3):781-790. doi: 10.1016/j.chest.2021.09.037. Epub 2021 Oct 8. | |
| 34172290 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Low-molecular-weight heparin | Drug | dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks |
|
|
| 3 months |
| Symptomatic recurrences of PE or DVT of the legs | excluding visceral thrombosis, upper extremity deep vein thrombosis and clinically unsuspected PE and DVT diagnosed incidentally | 3 months |
| Major and non-major clinically significant bleedings at day 90 | Clinically significant non-major bleedings are defined as any bleeding requiring hospitalization or a medical intervention including temporary withholding of anticoagulant treatment to stop bleeding. | 3 months |
| Mortality | 3 months |
| Angers |
| France |
| Espace Artois Santé | Arras | France |
| Hopital Saint Andre - Medecine vasculaire (015) | Bordeaux | France |
| CHU Brest - Departement de medecin interne et pneumologie (008) | Brest | France |
| CHU Le Bocage - Medecine interne 1 (014) | Dijon | France |
| CHU Grenoble - Medecine vasculaire (007) | Grenoble | France |
| CH Départemental La Roche sur Yon | La Roche-sur-Yon | France |
| Centre hospitalier Lyon Sud - Medecine interne (011) | Lyon | France |
| CHRU de Nîmes - Pneumologie (012) | Nîmes | France |
| HEGP - Pneumologie et soins intensifs (001) | Paris | 75015 | France |
| Institut Curie - Soins de support en Cancerologie (020) | Paris | France |
| CHU Saint Etienne - Medecin vasculaire et therapeutique (006) | Saint-Etienne | France |
| Hopital Saine Musse - Service de Medecine Vasculaire (010) | Toulon | France |
| CHU Rangueil - Medecin Vasculaire (019) | Toulouse | France |
| Derived |
| Riaz IB, Fuentes HE, Naqvi SAA, He H, Sipra QR, Tafur AJ, Padranos L, Wysokinski WE, Marshall AL, Vandvik PO, Montori V, Bryce AH, Liu H, Badgett RG, Murad MH, McBane RD 2nd. Direct Oral Anticoagulants Compared With Dalteparin for Treatment of Cancer-Associated Thrombosis: A Living, Interactive Systematic Review and Network Meta-analysis. Mayo Clin Proc. 2022 Feb;97(2):308-324. doi: 10.1016/j.mayocp.2020.10.041. Epub 2021 Jun 22. |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| D006495 | Heparin, Low-Molecular-Weight |
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided