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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00786422
Registration number
NCT00786422
Ethics application status
Date submitted
5/11/2008
Date registered
6/11/2008
Date last updated
18/11/2015
Titles & IDs
Public title
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
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Scientific title
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
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Secondary ID [1]
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2008-003303-31
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Secondary ID [2]
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13238
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis
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Deep Vein Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Experimental: Rivaroxaban (Xarelto, BAY59-7939) -
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pharmacodynamics - Prothrombin Time (PT), Baseline Value
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Assessment method [1]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline.
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Timepoint [1]
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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
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Primary outcome [2]
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Pharmacodynamics - Prothrombin Time (PT), Slope
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Assessment method [2]
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Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope.
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Timepoint [2]
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Up to 3 months treatment
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Primary outcome [3]
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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
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Assessment method [3]
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AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer.
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Timepoint [3]
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0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
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Primary outcome [4]
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Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
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Assessment method [4]
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Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.
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Timepoint [4]
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0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
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Primary outcome [5]
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Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
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Assessment method [5]
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Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer.
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Timepoint [5]
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0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
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Primary outcome [6]
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Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)
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Assessment method [6]
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All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
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Timepoint [6]
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Up to 3 months treatment and during subsequent 2 days
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Secondary outcome [1]
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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
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Assessment method [1]
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All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug).
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Timepoint [1]
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Up to 3 months treatment and during subsequent 30-day observational period for an individual participant
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Secondary outcome [2]
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Percentage of Participants With All Deaths
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Assessment method [2]
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All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure.
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Timepoint [2]
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Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month
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Secondary outcome [3]
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Percentage of Participants With Treatment Emergent Deaths - 7 Days Window
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Assessment method [3]
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Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure.
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Timepoint [3]
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Up to 3 months treatment and during subsequent 7 days
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Secondary outcome [4]
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Percentage of Participants With Other Vascular Events
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Assessment method [4]
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All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death.
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Timepoint [4]
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Up to 3 months treatment and during subsequent 1 day
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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- Redcliffe
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Recruitment postcode(s) [1]
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4020 - Redcliffe
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Wien
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Country [2]
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Brazil
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State/province [2]
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Sao Paulo
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Country [3]
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Germany
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State/province [3]
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Bayern
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Country [4]
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Hungary
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State/province [4]
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Debrecen
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Country [5]
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Israel
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State/province [5]
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Ashkelon
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Country [6]
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Israel
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State/province [6]
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Holon
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Country [7]
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Italy
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State/province [7]
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Pavia
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Country [8]
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Netherlands
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State/province [8]
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Amsterdam
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Country [9]
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South Africa
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State/province [9]
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Gauteng
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Country [10]
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South Africa
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State/province [10]
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Western Cape
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00786422
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bayer Study Director
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Address
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Bayer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00786422
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