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

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ClinicalTrials.gov Identifier: NCT02064439
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
Sponsor:
Collaborator:
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Bayer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Interventions: Drug: BAY 59-7939
Drug: ASA

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
In total 3439 participants were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 3439 participants screened 43 did not complete screening. Thus, 3396 participants were randomly assigned to treatment, 31 of the randomized participants never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations.

Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Acetylsalicylic (ASA) 100 mg, OD Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.

Participant Flow:   Overall Study
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD   Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD   Acetylsalicylic (ASA) 100 mg, OD
STARTED   1127 [1]   1107 [2]   1131 [2] 
COMPLETED   984   969   949 
NOT COMPLETED   143   138   182 
Adverse Event                51                47                46 
Death                0                2                3 
Withdrawal by Subject                29                18                26 
Protocol Violation                3                5                3 
Lost to Follow-up                1                3                4 
Non-compliance with study medication                21                19                23 
Physician Decision                0                1                1 
Logistical difficulties                6                5                2 
Efficacy outcome reached                18                16                57 
Safety outcome reached                12                20                10 
Other                2                2                7 
[1] Full Analysis Set (FAS), randomized and received study medication
[2] FAS, randomized and received study medication



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Acetylsalicylic (ASA) 100 mg, OD Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
Total Total of all reporting groups

Baseline Measures
   Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD   Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD   Acetylsalicylic (ASA) 100 mg, OD   Total 
Overall Participants Analyzed 
[Units: Participants]
 1127   1107   1131   3365 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.8  (14.7)   57.9  (14.7)   58.8  (14.7)   58.5  (14.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      507  45.0%      505  45.6%      488  43.1%      1500  44.6% 
Male      620  55.0%      602  54.4%      643  56.9%      1865  55.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      31   2.8%      31   2.8%      30   2.7%      92   2.7% 
Not Hispanic or Latino      892  79.1%      899  81.2%      889  78.6%      2680  79.6% 
Unknown or Not Reported      204  18.1%      177  16.0%      212  18.7%      593  17.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      2   0.2%      0   0.0%      2   0.2%      4   0.1% 
Asian      161  14.3%      159  14.4%      159  14.1%      479  14.2% 
Native Hawaiian or Other Pacific Islander      1   0.1%      1   0.1%      2   0.2%      4   0.1% 
Black or African American      41   3.6%      49   4.4%      36   3.2%      126   3.7% 
White      786  69.7%      772  69.7%      786  69.5%      2344  69.7% 
More than one race      1   0.1%      0   0.0%      5   0.4%      6   0.2% 
Unknown or Not Reported      135  12.0%      126  11.4%      141  12.5%      402  11.9% 


  Outcome Measures

1.  Primary:   Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism   [ Time Frame: Up to 12 months, at least 6 months ]

2.  Primary:   Number of Participants With First Treatment-emergent Major Bleeding   [ Time Frame: Up to 12 months, at least 6 months ]

3.  Secondary:   Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism   [ Time Frame: Up to 12 months, at least 6 months ]

4.  Secondary:   Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days   [ Time Frame: Up to 12 months, at least 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: Bayer AG
e-mail: clinical-trials-contact@bayer.com


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02064439     History of Changes
Other Study ID Numbers: 16416
2013-000619-26 ( EudraCT Number )
First Submitted: February 14, 2014
First Posted: February 17, 2014
Results First Submitted: September 12, 2017
Results First Posted: December 19, 2017
Last Update Posted: December 19, 2017