Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myelom… (NCT02066454) | Clinical Trial Compass
CompletedPhase 3
Evaluation of the Use of Apixaban in Prevnetion of Thromboembolic Disease in Patients With Myeloma Trated With iMiDs
France108 participantsStarted 2014-06-05
Plain-language summary
To evaluate:
* the incidence of venous thromboembolic event (VTE)
* the incidence of hemorrhagic complications, In a population of patients with myeloma who are treated with IMiDs and require thromboprophylaxis for 6 months, using an oral anti-Xa anticoagulant, Apixaban, in a preventive scheme, 2.5 mg x2/day
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients (men/women) aged more than 18 years
* All consecutive patients, with myeloma, in first-line treatment or in relapse, who are treated - With IMiDs (MPT, Melphalan -Prednisone -Thalidomide ; Lenalidomide - Dexamethasone).
AND
\- who require prevention of venous thromboembolic events with Aspirin or Low molecular Weight Heparin (LMWH) for a minimum duration of 6 months At least, 2/3 of patients will be treated with Lenalidomide-Dexamethasone.
* Written informed consent
* Patients affiliated to the French social security system or equivalent
Exclusion Criteria:
* Patient who needs curative anticoagulant treatment (heparin, LMWH, vitamin K antagonists, Dabigatran, Rivaroxaban, Apixaban) for an associated disorder (mechanical valve, atrial fibrillation or venous thromboembolic disease in the previous 6 months).
* Patient who needs preventive treatment with an anticoagulant in a post-operative context
* Patient who needs anti-platelet treatment (Aspirin, Clopidogrel, Prasugrel, Ticagrelor or dual anti-platelet therapy )
* Patient with active bleeding or at a high risk of bleeding (ulcer disease, intracranial bleeding in the previous 6 months, uncontrolled hypertension)
* Patient having undergone a surgical intervention within the past 30 days likely to expose them to an haemorrhagic risk
* Active hepatic disease (hepatitis, cirrhosis)
* Severe renal insufficiency (creatinine clearance using the Cockcroft equation \< 30 ml/mn)
* Known allergic rea…
What they're measuring
1
Total VTE and VTE-related death. Major and clinically relevant non major bleeding - Major and clinically relevant non major bleeding, defined according to International Society of Thrombosis and haemostasis