Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban (CASTA-DIVA)
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ClinicalTrials.gov Identifier: NCT02746185 |
Recruitment Status :
Completed
First Posted : April 21, 2016
Last Update Posted : August 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Neoplasm Venous Thromboembolism | Drug: rivaroxaban Drug: Low-molecular-weight heparin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 159 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study. |
Actual Study Start Date : | September 2016 |
Actual Primary Completion Date : | April 25, 2018 |
Actual Study Completion Date : | April 25, 2018 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Low-molecular-weight heparin
dalteparin, 200 IU/kg subcutaneously once daily for one month followed by 150 IU/kg subcutaneously once daily for 2 months
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Drug: Low-molecular-weight heparin
dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks
Other Name: dalteparin |
Experimental: Rivaroxaban
rivaroxaban, orally, 15 mg twice daily for 3 weeks followed by 20 mg once daily for 9 weeks
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Drug: rivaroxaban
rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks
Other Name: xarelto |
- Symptomatic DVT [ Time Frame: 3 months ]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)
- Symptomatic PE [ Time Frame: 3 months ]Recurrent VTE during the 3-month treatment period including symptomatic PE
- Unsuspected PE and DVT [ Time Frame: 3 months ]Recurrent VTE during the 3-month treatment period including clinically unsuspected PE and DVT discovered incidentally
- Worsening of pulmonary vascular or venous obstruction [ Time Frame: 3 months ]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
- Major and clinically significant bleedings during the 3-month treatment period [ Time Frame: 3 months ]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.
- Symptomatic recurrences of PE or DVT of the legs [ Time Frame: 3 months ]excluding visceral thrombosis, upper extremity deep vein thrombosis and clinically unsuspected PE and DVT diagnosed incidentally
- Major and non-major clinically significant bleedings at day 90 [ Time Frame: 3 months ]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.
- Mortality [ Time Frame: 3 months ]
- Rivaroxaban plasma concentrations [ Time Frame: 3 months ]Area under the plasma concentration versus time curve (AUC) determined using a liquid chromatography-tandem mass spectrometry method

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years
- Social security affiliation
- Written informed consent
- Solid active cancer, high grade lymphoma or myeloma treated with Immunomodulatory drugs (IMiDs) (thalidomide or lenalidomide). Active cancer is defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy or targeted therapy at inclusion.
- Histologically or cytologically proven cancer.
- Symptomatic venous thromboembolism objectively confirmed diagnosed because of symptoms or discovered incidentally
- High-risk of recurrent Venous thromboembolism (VTE) defined by a score of 0 or ≥ 1, using the following criteria: female sex (+1), lung cancer (+1), breast cancer (-1) non metastatic tumor (-2), previous VTE (+1).
Exclusion Criteria:
- Exclusive adjuvant hormonal treatment with no measurable residual disease
- Sub-segmental isolated pulmonary embolism (PE) without associated proximal DVT
- Isolated distal deep vein thrombosis (DVT) of the legs
- Isolated upper-extremity DVT or superior vena cava thrombosis
- Isolated visceral thrombosis
- Platelet count < 50 000 G/L
- Active bleeding
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
- Hemostatic defect with contraindication to anticoagulant treatment at therapeutic dosage
- Vena cava filter at inclusion
- Fibrinolytic therapy within 3 days preceding inclusion
- Creatinine clearance < 30 ml/min according to Cockcroft-Gault formula
- Previous heparin-induced thrombocytopenia
- Anticoagulant treatment at curative dosage for more than 3 days before inclusion
- Pregnancy or lack of effective contraceptive treatment for women of childbearing age
- Treatment with both strong CYP3A4 and P-glycoprotein (PgP) inhibitors: protease inhibitors for HIV disease, systemic ketoconazole
- Treatment with a strong CYP3A4 inducer: rifampicin, carbamazepine, phenytoin.
- Life expectancy < 3 months
- Eastern Cooperative Oncology Group (ECOG) level 3 or 4

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746185
France | |
CHU Amiens - Medecine vasculaire (003) | |
Amiens, France | |
CHU Angers - Medecin Interne (002) | |
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, France, 75015 | |
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 |
Principal Investigator: | Guy Meyer, MD | APHP - HEGP |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT02746185 |
Other Study ID Numbers: |
P141204 |
First Posted: | April 21, 2016 Key Record Dates |
Last Update Posted: | August 13, 2018 |
Last Verified: | August 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
cancer venous thromboembolism low-molecular weight heparin rivaroxaban |
Thromboembolism Venous Thromboembolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Heparin Heparin, Low-Molecular-Weight Tinzaparin Dalteparin Rivaroxaban |
Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors |