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

November 5, 2008
July 28, 2013
May 2009
May 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00786422 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Symptomatic recurrent VTE [ 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 ]
Not Provided
Not Provided
 
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Venous Thrombosis
  • Deep Vein Thrombosis
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.
Experimental: Arm 1
Intervention: Drug: Rivaroxaban (Xarelto,BAY59-7939)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Brazil,   Germany,   Hungary,   Israel,   Italy,   Netherlands,   South Africa
 
NCT00786422
13238, 2008-003303-31
Yes
Head Clinical Pharmacology, Bayer Healthcare Pharmaceutical Inc.
Bayer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Bayer Study Director Bayer
Bayer
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP