Phase 2 N=25 Treatment

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

Venous Thrombosis · Deep Vein Thrombosis

Bottom Line

View on ClinicalTrials.gov: NCT00786422 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Jun 2014

Primary outcome: Primary: Pharmacodynamics - Prothrombin Time (PT), Baseline Value — 15.8 Seconds

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Rivaroxaban (Xarelto, BAY59-7939) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacodynamics - Prothrombin Time (PT), Baseline Value	15.8	—
PRIMARY Pharmacodynamics - Prothrombin Time (PT), Slope	0.0389	—
PRIMARY Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban	2836; 2319	—
PRIMARY Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban	200; 167	—
PRIMARY Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban	42; 35	—
PRIMARY Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)	12.0; 8.0; 8.0	—
SECONDARY Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment	8.0; 4.0; 4.0	—
SECONDARY Percentage of Participants With All Deaths	12.0	—
SECONDARY Percentage of Participants With Treatment Emergent Deaths - 7 Days Window	8.0	—
SECONDARY Percentage of Participants With Other Vascular Events	0.0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00786422). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.