Edoxaban/heparin versus dalteprin in cancer patients for prevention of thrombosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1000

Inclusion Criteria

Adult subjects presenting with VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with LMWH is intended are eligible to participate in the study.
Subjects must satisfy all of the following criteria to be included in the study:
1. Male or female subjects with age = 18 years or the otherwise legal lower age according to the country of residence;
2. Confirmed symptomatic or unsuspected lower extremity proximal DVT (ie, popliteal, femoral, iliac or inferior vena cava (IVC) vein thrombosis), or confirmed symptomatic PE, or unsuspected PE of a segmental or larger pulmonary artery;
3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to randomization. [Note: Diagnosis of cancer must be objectively documented];
4. Intention for long-term treatment (at least 6 months) with parenteral LMWH;
5. Able to provide written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 620

Exclusion Criteria

1. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current (index) episode of DVT and/or PE;
2. More than 72 hours pre-treatment with therapeutic dosages of anticoagulant treatment (LMWH, unfractionated heparin, and fondaparinux per local labeling), oral direct anticoagulants or VKA prior to randomization to treat the current (index) episode;
3. Treatment with therapeutic doses of an anticoagulant other than that used for pretreatment of the current (index) VTE episode prior to randomization;
4. Active bleeding or any contraindication for treatment with LMWH/dalteparin or edoxaban;
5. Indication for dalteparin other than DVT and/or PE;
6. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or 4 at the time of randomization (Appendix 17.6);
7. Calculated CrCL < 30 mL/min;
8. History of heparin associated thrombocytopenia;
9. Acute hepatitis, chronic active hepatitis, liver cirrhosis;
10. Hepatocelullar injury with concurrent transaminase (ALT/AST > 3 x ULN) and bilirubin (> 2 x ULN) elevations in the absence of a clinical explanation;
11. Life expectancy < 3 months;
12. Platelet count < 50,000/mL;
13. Uncontrolled hypertension as judged by the Investigator (eg, systolic blood pressure (BP) > 170 mmHg or diastolic blood pressure > 100 mmHg despite antihypertensive treatment);
14. Women of childbearing potential without proper contraceptive measures, and women who are pregnant or breast feeding;
Note: Childbearing potential without proper contraceptive measures (ie, a method of contraception with a failure rate < 1 % during the course of the study including the observational period). These methods of contraception according to the note for guidance on nonclinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence, and vasectomy for the male partner).
15. Chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) including both cyclooxygenase-1 (COX-1) and cyclooxygenase-2
(COX-2) inhibitors for = 4 days/week anticipated to continue during the study;
16. Treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy (any 2 antiplatelet agents including aspirin plus any other oral or intravenous [IV] antiplatelet drug) anticipated to continue during the study;
17. Treatment with the P-gp inhibitors ritonavir, nelfinavir, indinavir, or saquinavir anticipated to continue during the study;
18. Systemic use of the P-gp inhibitors ketoconazole, itraconazole, erythromycin, azithromycin or clarithromycin at the time of randomization; subsequent use is permitted;
19. Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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