Conditions: Venous Thrombosis Deep Vein Thrombosis
Keywords: Embolism and Thrombosis Pulmonary Embolism Embolism Venous Thrombosis Thrombosis Enzyme Inducers CYP Inducers Cohort Study Pharmacologic Actions Respiratory Tract Diseases Lung Diseases Vascular Diseases Human Immunodeficiency Virus (HIV) Neurologic disease Additional relevant MeSH terms: Fibrin Modulating Agents Anticoagulants Therapeutic Uses Hematologic Agents Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
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.

Detailed 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.

Arms:
arm 1: None

Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939)
Intervention descriptions: intervention 1: Participants received 30 mg rivaroxaban bid (twice-daily) orally for the first 3 weeks followed by 20 mg rivaroxaban bid for the remainder of the 3-month treatment period.

Protocol document: