check_circleStudy Completed

Venous Thrombosis, Deep Vein Thrombosis

Bayer Identifier:

13238

ClinicalTrials.gov Identifier:

NCT00786422

EudraCT Number:

2008-003303-31

EU CT Number:

Not Available
Deep vein thrombosis treatment with the Oral Direct Factor Xa Inhibitor Rivaroxaban in patients using a strong CYP 3A4 inducer

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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)
  • - 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
25
Trial Dates
May 2009 - June 2011
Phase
Phase 2
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Praxis Hr. Dr. P. Baron von BilderlingMünchen, 80331, Germany
Terminated
Academisch Medisch Centrum Universiteit van AmsterdamAMSTERDAM, 1105 AZ, Netherlands
Terminated
Mayo ClinicRoodepoort, 1724, South Africa
Terminated
Unitas HospitalPretoria, 0157, South Africa
Terminated
Barzilai Medical CenterAshkelon, 7830604, Israel
Terminated
Redcliffe District HospitalRedcliffe, 4020, Australia
Terminated
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Terminated
University of DebrecenDebrecen, 4032, Hungary
Terminated
Real Benemérita Ass Portug Beneficiência-Hosp S. JoaquimSão Paulo, 01323-001, Brazil
Terminated
IRCCS Policlinico San MatteoPavia, 27100, Italy
Completed
Pretoria Academic Hospital NewPretoria, 0084, South Africa
Terminated
Helderberg Medical Clinical TrialsSomerset West, 7130, South Africa
Completed
University of WitwatersrandJohannesburg, 2132, South Africa
Terminated
Clinical Projects Research SAWorcester, 6850, South Africa
Terminated
Unitas HospitalPretoria, 0157, South Africa
Completed
Folateng Charlotte Maxeke Johannesburg Academic HospitalJohannesburg, 2193, South Africa
Terminated
Edith Wolfson Medical CenterHolon, 58100, Israel

Primary Outcome

  • Pharmacodynamics - Prothrombin time (PT), baseline value
    date_rangeTime Frame:
    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
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacodynamics - Prothrombin time (PT), slope
    date_rangeTime Frame:
    Up to 3 months treatment
    enhanced_encryption
    Safety Issue:
    No
  • 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
    date_rangeTime Frame:
    0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics – Cmax,ss (maximum observed drug concentration in measured matrix at steady state during a dosage interval) of rivaroxaban
    date_rangeTime Frame:
    0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No
  • Pharmacokinetics – Cmin,ss (minimum observed drug concentration in measured matrix at steady state during a dosage interval) of rivaroxaban
    date_rangeTime Frame:
    0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding)
    date_rangeTime Frame:
    Up to 3 months treatment and during subsequent 2 days
    enhanced_encryption
    Safety Issue:
    Yes

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 treatment
    date_rangeTime Frame:
    Up to 3 months treatment and during subsequent 30-day observational period for an individual participant
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with all deaths
    date_rangeTime Frame:
    Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with treatment emergent deaths - 7 days window
    date_rangeTime Frame:
    Up to 3 months treatment and during subsequent 7 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Percentage of participants with other vascular events
    date_rangeTime Frame:
    Up to 3 months treatment and during subsequent 1 day
    enhanced_encryption
    Safety Issue:
    Yes

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

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