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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
2008-003303-31
Secondary ID [2] 0 0
13238
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacodynamics - Prothrombin Time (PT), Baseline Value
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Pharmacodynamics - Prothrombin Time (PT), Slope
Timepoint [2] 0 0
Up to 3 months treatment
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
Primary outcome [4] 0 0
Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
Timepoint [4] 0 0
0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
Primary outcome [5] 0 0
Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
Timepoint [5] 0 0
0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban
Primary outcome [6] 0 0
Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)
Timepoint [6] 0 0
Up to 3 months treatment and during subsequent 2 days
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 3 months treatment and during subsequent 30-day observational period for an individual participant
Secondary outcome [2] 0 0
Percentage of Participants With All Deaths
Timepoint [2] 0 0
Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month
Secondary outcome [3] 0 0
Percentage of Participants With Treatment Emergent Deaths - 7 Days Window
Timepoint [3] 0 0
Up to 3 months treatment and during subsequent 7 days
Secondary outcome [4] 0 0
Percentage of Participants With Other Vascular Events
Timepoint [4] 0 0
Up to 3 months treatment and during subsequent 1 day

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Redcliffe
Recruitment postcode(s) [1] 0 0
4020 - Redcliffe
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Germany
State/province [3] 0 0
Bayern
Country [4] 0 0
Hungary
State/province [4] 0 0
Debrecen
Country [5] 0 0
Israel
State/province [5] 0 0
Ashkelon
Country [6] 0 0
Israel
State/province [6] 0 0
Holon
Country [7] 0 0
Italy
State/province [7] 0 0
Pavia
Country [8] 0 0
Netherlands
State/province [8] 0 0
Amsterdam
Country [9] 0 0
South Africa
State/province [9] 0 0
Gauteng
Country [10] 0 0
South Africa
State/province [10] 0 0
Western Cape

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00786422
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00786422