None listed
Conditions
Interventions
-Pi (Rivaroxaban): Rivaroxaban 15mg, 2 tablets / day for 3Sem, then Rivaroxaban 20mg, 1 tablet / day thereafter.
-Control (Enoxaparin / AVK): You will receive Enoxaparin 1.0mg / kg, 2 times / day,
2.0 in 2 consecutive determinations with 24Hs of difference. The dose of AVK (Warfarin or Acenocumarol) will be adjusted to maintain the INR within the therapeutic margins (2.0-3.0).
Sponsors
BAYER HEALTHCARE AG,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. For the Einstein-DVT evaluation: Confirmed acute symptomatic PD without symptomatic PD or For Einstein-EP assessment: Acute symptomatic PD confirmed with or without symptomatic DVT. 2. FCI in writing.
Exclusion criteria
Exclusion criteria: 1.Legal lower age limitations (country specific). 2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE. 3. Other indication for VKA than DVT and/or PE. 4. More than 48 hours pre-randomization treatment with therapeutic dosages of anticoagulant treatment or more than a single dose of VKA prior to randomization. 5. Participation in another pharmacotherapeutic study within 30 days. 6. Creatinine clearance 3 x ULN. 8. Bacterial endocarditis. 9. Life expectancy 180 mmHg or diastolic blood pressure >110 mmHg. 12. Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. 13. Any other contraindication listed in the local labeling of warfarin, Acenocoumarol, or enoxaparin. 14. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketokonazole) or strong CYP3A4 inducers like rifampicin.
Contacts
Public ContactGino Mejia
COVANCE PERU SERVICES S.A.
Outcome results
None listed