Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism using a strong CYP 3A4 inducer.

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

1. Confirmed acute symptomatic proximal DVT and/or PE
2. Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, or rifabutin) during the entire 3-month study period
3. Written informed consent

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 36 hours of treatment with therapeutic dosages of anticoagulant treatment or more than a single dose of VKA prior to inclusion
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 (i.e. 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 non-
clinical 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), pregnancy or breast feeding.
13. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
14. Use of the strong CYP 3 A4 inducers phenobarbital/primidone or St John*s Wort

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to characterize the population PK/PD of an adapted<br /><br>rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis<br /><br>(DVT) or acute pulmonary embolism (PE) and concomitant use of a strong CYP 3A4<br /><br>inducer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The occurrence of symptomatic recurrent venous thromboembolism and major and<br /><br>clinically relevant non-major bleeding will be documented.</p><br>

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