Trial Condition(s):
Venous thrombosis
Deep vein thrombosis treatment with the Oral Direct Factor Xa Inhibitor Rivaroxaban in patients using a strong CYP 3A4 inducer
Bayer Identifier:
13238
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Praxis Hr. Dr. P. Baron von Bilderling München, Germany, 80331 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academisch Medisch Centrum Universiteit van Amsterdam AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic Roodepoort, South Africa, 1724 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Unitas Hospital Pretoria, South Africa, 0157 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Redcliffe District Hospital Redcliffe, Australia, 4020 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Real Benemérita Ass Portug Beneficiência-Hosp S. Joaquim São Paulo, Brazil, 01323-001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Policlinico San Matteo Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pretoria Academic Hospital New Pretoria, South Africa, 0084 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helderberg Medical Clinical Trials Somerset West, South Africa, 7130 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Projects Research SA Worcester, South Africa, 6850 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Folateng Charlotte Maxeke Johannesburg Academic Hospital Johannesburg, South Africa, 2193 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel, 58100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
The EINSTEIN CYP cohort study Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism using a strong CYP 3A4 inducer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Pharmacodynamics - Prothrombin time (PT), baseline valueTimeframe: The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period
- Pharmacodynamics - Prothrombin time (PT), slopeTimeframe: Up to 3 months treatment
- 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 rivaroxabanTimeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
- Pharmacokinetics – Cmax,ss (maximum observed drug concentration in measured matrix at steady state during a dosage interval) of rivaroxabanTimeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
- Pharmacokinetics – Cmin,ss (minimum observed drug concentration in measured matrix at steady state during a dosage interval) of rivaroxabanTimeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
- Percentage of participants with clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding)Timeframe: Up to 3 months treatment and during subsequent 2 days
Secondary Outcome
- 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 treatmentTimeframe: Up to 3 months treatment and during subsequent 30-day observational period for an individual participant
- Percentage of participants with all deathsTimeframe: Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month
- Percentage of participants with treatment emergent deaths - 7 days windowTimeframe: Up to 3 months treatment and during subsequent 7 days
- Percentage of participants with other vascular eventsTimeframe: Up to 3 months treatment and during subsequent 1 day
Additional Information
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