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:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00786422
First received: November 5, 2008
Last updated: July 28, 2013
Last verified: July 2013
  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: July 28, 2013
Health Authority: United States: Food and Drug Administration
South Africa: Medicine Control Council

Keywords provided by Bayer:
Embolism and Thrombosis
Pulmonary Embolism
Embolism
Venous Thrombosis
Thrombosis
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:
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Lung Diseases
Respiratory Tract Diseases
Embolism
Embolism and Thrombosis
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 April 15, 2014