Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
This study has been completed.
Sponsor:
Bayer
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00786422
First received: November 5, 2008
Last updated: August 9, 2012
Last verified: August 2012
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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 CYP 3A4 inducer for the entire 3-month study duration.
| Condition | Intervention | Phase |
|---|---|---|
|
Venous Thrombosis Deep Vein Thrombosis |
Drug: Rivaroxaban (Xarelto,BAY59-7939) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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. [ Time Frame: 3 month study treatment period ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Symptomatic recurrent deep -vein thrombosis [ Time Frame: 3 month study treatment period ] [ Designated as safety issue: No ]
- Clinically relevant bleeding (i.e., major bleeding and clinically relevant non-major bleeding) [ Time Frame: 3 month study treatment period ] [ Designated as safety issue: No ]
- All deaths and other vascular events [ Time Frame: 3 month study treatment period ] [ Designated as safety issue: Yes ]
| Enrollment: | 25 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Drug: Rivaroxaban (Xarelto,BAY59-7939)
During the first 3 weeks patients will receive 30 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg twice-daily. Rivaroxaban will be administered orally and should be taken with food.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 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 3 A4 inducers phenobarbital/primidone or St John's Wort
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786422
Locations
| Australia, Queensland | |
| Redcliffe, Queensland, Australia, 4020 | |
| Austria | |
| Wien, Austria, 1090 | |
| Brazil | |
| São Paulo, Sao Paulo, Brazil, 01323-001 | |
| Germany | |
| München, Bayern, Germany, 80331 | |
| Hungary | |
| Debrecen, Hungary, 4032 | |
| Israel | |
| Ashkelon, Israel, 78306 | |
| Holon, Israel, 58100 | |
| Italy | |
| Pavia, Italy, 27100 | |
| Netherlands | |
| Amsterdam, Netherlands, 1105 AZ | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 2193 | |
| Johannesburg, Gauteng, South Africa, 2132 | |
| Pretoria, Gauteng, South Africa, 0157 | |
| Pretoria, Gauteng, South Africa, 0084 | |
| Roodepoort, Gauteng, South Africa, 1724 | |
| Somerset West, Western Cape, South Africa, 7130 | |
| Worcester, Western Cape, South Africa, 6850 | |
Sponsors and Collaborators
Bayer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Head Clinical Pharmacology, Bayer Healthcare Pharmaceutical Inc. |
| ClinicalTrials.gov Identifier: | NCT00786422 History of Changes |
| Other Study ID Numbers: | 13238, 2008-003303-31 |
| Study First Received: | November 5, 2008 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United States: Food and Drug Administration South Africa: Medicine Control Council |
Keywords provided by Bayer:
|
Embolism and Thrombosis Venous Thrombosis Thrombosis Pulmonary Embolism Embolism Enzyme Inducers CYP Inducers Cohort Study Pharmacologic Actions Respiratory Tract Diseases Lung Diseases |
Vascular Diseases HIV Neurologic disease Additional relevant MeSH terms: Fibrin Modulating Agents Anticoagulants Therapeutic Uses Hematologic Agents Enzyme Inhibitors Cardiovascular Diseases Cardiovascular Agents |
Additional relevant MeSH terms:
|
Thrombosis Venous Thrombosis Embolism and Thrombosis Pulmonary Embolism Venous Thromboembolism Lung Diseases Respiratory Tract Diseases Embolism |
Vascular Diseases Cardiovascular Diseases Thromboembolism Cardiovascular Agents Fibrin Modulating Agents Therapeutic Uses Pharmacologic Actions Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013