Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (EinsteinChoice)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02064439
First received: February 14, 2014
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.

Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial


Condition Intervention Phase
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Drug: BAY 59-7939
Drug: ASA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of patients with fatal or non-fatal symptomatic recurrent venous thromboembolism [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Percentage of participants with major bleeding [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of participants with myocardial infarction, ischemic stroke or systemic non-CNS embolism [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants with Clinically relevant non-major bleeding) [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants with myocardial infarction, ischemic stroke, systemic non-CNS embolism or all cause mortality [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
  • Percentage of participants with major bleeding and recurrent venous thromboembolism [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
  • Percentage of participants with major bleeding, recurrent venous thromboembolism, myocardial infarction, ischemic stroke and systemic non-CNS embolism [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2850
Study Start Date: March 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Rivaroxaban 10 mg once daily for 12 months
Drug: BAY 59-7939
10 mg tablet once daily for 12 months
Experimental: Arm 2
Rivaroxaban 20 mg once daily for 12 months
Drug: BAY 59-7939
20 mg tablet once daily for 12 months
Active Comparator: Arm 3
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Drug: ASA
100 mg tablet once daily for 12 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week

Exclusion Criteria:

  • Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02064439

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

  Show 172 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064439     History of Changes
Other Study ID Numbers: 16416
Study First Received: February 14, 2014
Last Updated: August 26, 2014
Health Authority: Australia: Department of Health
Austria: Ministry of Labor, Health and Social Affairs
Belgium: Ministry of Social Affairs, Public Health and the Environment
Brazil: Ministry of Health
Canada: Health Protection Branch
China: Ministry of Health- State Food and Drug Administration
Czech Republic: Ministry of Health
Denmark: Danish Medicines Agency
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Scientific and Medical Research Council Ethics Committee
Israel: Ministry of Health
Italy: Ministry of Health
Korea: Food and Drug Administration
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board
New Zealand: Medicines and Medical Devices Safety Authority
Norway: Ministry of Health and Care Services
Philippines: Department of Health
Poland: Ministry of Health and Social Security - Drug Institute
Russia: Ministry of Health
South Africa:
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
Switzerland: Federal Office of Public Health
Taiwan: Department of Health
Thailand: Ministry of Public Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Vietnam: Ministry of Health

Keywords provided by Bayer:
deep vein thrombosis
pulmonary embolism
long-term prevention of recurrent symptomatic VTE

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014