Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer

Bayer

Status and phase

Completed

Phase 2

Conditions

Deep Vein Thrombosis

Venous Thrombosis

Treatments

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00786422

13238

2008-003303-31 (EudraCT Number)

Details and patient eligibility

About

This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450 isoenzyme 3A4 (CYP 3A4) inducer for the entire 3-month study duration.

Full description

The following laboratory variables were determined at baseline at the local laboratories: Hemoglobin, platelets, activated partial thromboplastin time (aPTT), international normalized ratio (INR), alanine aminotransferase (ALT), and creatinine.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed acute symptomatic proximal deep- vein thrombosis and/or pulmonary embolism
Concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin)

Exclusion criteria

Legal lower age limitations (country specific)
Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of deep -vein thrombosis and/or pulmonary embolism
Other indication for vitamin K antagonist (VKA) than deep -vein thrombosis and/or pulmonary embolism
Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
Use of the strong CYP 3A4 inducers phenobarbital/primidone or St John's Wort