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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2008-003303-31-HU |
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Date of registration:
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18/12/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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. - The Einstein CYP cohort study
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Scientific title:
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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. - The Einstein CYP cohort study |
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Date of first enrolment:
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17/08/2009 |
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Target sample size:
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50 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003303-31 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Germany
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Hungary
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Italy
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Netherlands
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Contacts
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Name:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. confirmed acute symptomatic proximal DVT and/or PE
2. concomitant use of a strong CYP 3A4 inducer, (i.e., carbamazepine, phenytoin, rifampicin/rifampin, and rifabutin) during the entire 3-month study period
3. Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Legal lower age limitations (country specific)
2. Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE
3. Other indication for VKA than DVT and/or PE
4. More than 36 hours of treatment with therapeutic dosages of anticoagulant treatment or more than a single dose of VKA prior to inclusion
5. Participation in another pharmacotherapeutic study within 30 days
6. Creatinine clearance < 30 ml/min
7. Significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN
8. Bacterial endocarditis
9. Life expectancy <3 months
10. Active bleeding or high risk for bleeding contraindicating treatment with
enoxaparin or VKA
11. Systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
12. Childbearing potential without proper contraceptive measures (i.e. a method of contraception with a failure rate < 1 % during the course of the study (including the observational period). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy), pregnancy or breast feeding.
13. Concomitant use of strong CYP3A4 inhibitors (e.g., HIV protease inhibitors, systemic ketoconazole)
14. Use of the strong CYP 3 A4 inducers phenobarbital/primidone or St John’s Wort
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with acute, proximal DVT or acute PE who concomitantly use a strong CYP 3A4 inducer for the entire 3-month study duration.
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Intervention(s)
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Product Name: rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rivaroxaban
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 15-
Product Name: rivaroxaban
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rivaroxaban
CAS Number: 366789-02-8
Current Sponsor code: BAY 59-7939
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Main Objective: The primary objective is to characterize the population PK/PD of an adapted
rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) and concomitant use of a strong CYP 3A4 inducer.
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Secondary Objective: Additional objectives are to document the occurrence of 1) symptomatic recurrent venous thromboembolism and 2) major and clinically relevant non-major bleeding.
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Primary end point(s): For the investigation of pharmacokinetics, rivaroxaban plasma concentrations will be determined at day 15±1, day 30±7, day 60±7, and day 91-98 (see flow chart) using a sparse sampling approach in all patients. PK modelling using population approaches to characterize rivaroxaban pharmacokinetics (including potential influence of relevant patient covariates such as age, gender, body weight, and renal function) will be done in a similar way as previously conducted for the DVT Phase II dose-ranging studies under a separate detailed PK-evaluation plan.
Pharmacodynamic trough and peak levels of rivaroxaban will be evaluated by measurement
of prothrombin time (PT) and prothrombinase induced clotting time (PICT).
The efficacy outcome is symptomatic recurrent VTE, i.e., the composite of DVT or fatal or non-fatal PE.
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Secondary ID(s)
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2008-003303-31-NL
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BAY59-7939/13238
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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