NOT AVAILABLE

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-027-10
• Date of registration: 14/06/2010
• Prospective Registration: Yes
• Primary sponsor: BAYER HEALTHCARE AG,
• Public title: NOT AVAILABLE
• Scientific title: “RIVAROXABAN ORAL, DIRECT INHIBITOR OF XA ORAL FACTOR IN PATIENTS WITH DEEP VENOUS THROMBOSIS OR LUNG EMBOLIS SYMPTOMATIC ACIDS”
• Date of first enrolment: 01/01/1900
• Target sample size: 24
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=027-10
• Study type: Interventional
• Study design: Phase III study, randomized, multicenter, open-label, event-oriented, non-inferiority efficacy trial with a duration of 3, 6, or 12 months in patients with confirmed symptomatic DVT without symptomatic PE (Einstein- DVT). The program consists of 2 independent evaluations: 1) In patients with confirmed symptomatic DVT without symptomatic PE and 2) In patients with confirmed symptomatic PE with or without symptomatic DVT. In symptomatic PE, a dose confirmation phase will be performed.
• Phase: III

Contacts

• Name: Gino Silva Mejia
• Affiliation: COVANCE PERU SERVICES S.A.

• Name: Gino Silva Mejia
• Affiliation: COVANCE PERU SERVICES S.A.

Key inclusion & exclusion 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:
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 < 30 ml/min. 7. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN. 8. Bacterial endocarditis. 9. Life expectancy <3 months. 10. Active bleeding or high risk for bleeding contraindicating treatment with enoxaparin or VKA. 11. Systolic blood pressure >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.


Age minimum: 18
Age maximum: 100
Gender: --

Intervention(s)

-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, with a minimum duration of 5 days, and will be maintained until the INR is ≥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).

Secondary ID(s)

NCT00440193

N.A.

EUCTR2006-004495-13-BE

Ethics review

Status: Approved
Approval date: 29/01/2010
Contact:

[e-mail]

Hospital Nacional Arzobispo Loayza

88339014 - 3301677

[e-mail]

Status: Approved
Approval date: 30/03/2010
Contact:

[e-mail]

Hospital Nacional Alberto Sabogal Sologuren

4297744 anexo 5388

[e-mail]

Status: Approved
Approval date: 01/04/2010
Contact:

[e-mail]

Hospital Nacional Dos de Mayo

3280028

[e-mail]