We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention (PIONEER AF-PCI)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830543
First Posted: April 12, 2013
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
Results First Submitted: June 30, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Percutaneous Coronary Intervention
Interventions: Drug: rivaroxaban 2.5 mg
Drug: rivaroxaban 15 mg
Drug: rivaroxaban 10 mg
Drug: aspirin (ASA)
Drug: vitamin K antagonist (VKA)
Drug: clopidogrel
Drug: prasugrel
Drug: ticagrelor

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rivaroxaban 15 mg Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Vitamin K Antagonist (VKA) Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.

Participant Flow:   Overall Study
    Rivaroxaban 15 mg   Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)   Vitamin K Antagonist (VKA)
STARTED   709   709   706 
Treated   696   706   697 
COMPLETED   550   557   492 
NOT COMPLETED   159   152   214 
Subject Decision                19                21                57 
Adverse Event                91                77                76 
Death                20                22                22 
Protocol Violation                3                7                7 
Physician Decision                11                5                12 
Withdrawal by consent                3                3                3 
Other                12                17                37 



  Baseline Characteristics
  Hide 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.
The intent-to-treat analysis set included all randomized participants.

Reporting Groups
  Description
Rivaroxaban 15 mg Participants received rivaroxaban 15 milligram (mg) or 10 mg (for participants with moderate renal impairment [creatinine clearance (CrCl): 30 to less than (<) 50 milliliter per minute (mL/min)]) once daily plus background therapy with clopidogrel 75 mg once daily or alternate P2Y12 inhibitor (prasugrel 10 mg per day or ticagrelor 90 mg twice daily) for 12 months.
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD) Participants received rivaroxaban 2.5 mg twice daily plus background dual antiplatelet therapy (DAPT) with low-dose acetylsalicylic acid (ASA) 75 to 100 mg per day and clopidogrel 75 mg once daily (or alternate P2Y12 inhibitor [prasugrel or ticagrelor]) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive rivaroxaban 15 mg or 10 mg (for participants with moderate renal impairment) once daily plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Vitamin K Antagonist (VKA) Participants received dose adjusted (to a target of international normalized ratio [INR] 2.0 to 3.0 [or target INR 2.0 to 2.5]) vitamin K antagonist (VKA) [example warfarin, acenocoumarol; assigned by the investigator according to approved formulations) once daily plus background DAPT (clopidogrel 75 mg [or alternate P2Y12 inhibitor (prasugrel or ticagrelor)] plus low-dose ASA [75 to 100 mg] daily) for an intended DAPT duration of 1, 6, or 12 months. Only participants with an intended DAPT duration of 1 or 6-month transitioned to receive dose-adjusted VKA plus background single antiplatelet therapy with low-dose ASA for the rest of the period up to Month 12.
Total Total of all reporting groups

Baseline Measures
   Rivaroxaban 15 mg   Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)   Vitamin K Antagonist (VKA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 709   709   706   2124 
Age 
[Units: Years]
Mean (Standard Deviation)
 70.4  (9.12)   70  (9.11)   69.9  (8.67)   70.1  (8.97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      181  25.5%      174  24.5%      188  26.6%      543  25.6% 
Male      528  74.5%      535  75.5%      518  73.4%      1581  74.4% 
Region of Enrollment 
[Units: Participants]
       
Argentina   32   27   23   82 
Australia   3   7   5   15 
Belgium   14   18   20   52 
Brazil   14   14   13   41 
Bulgaria   67   80   74   221 
Canada   23   24   19   66 
Chile   5   7   6   18 
Czech Republic   17   9   14   40 
Denmark   2   2   8   12 
France   33   26   25   84 
Germany   96   98   101   295 
Italy   26   26   20   72 
Korea, Republic of   11   11   17   39 
Malaysia   1   5   5   11 
Mexico   7   3   3   13 
Netherlands   24   17   27   68 
Poland   71   78   69   218 
Romania   15   16   19   50 
Russian Federation   90   86   89   265 
Sweden   15   14   18   47 
Taiwan, Province of China   8   8   9   25 
Turkey   11   14   18   43 
Ukraine   19   24   17   60 
United Kingdom   48   44   39   131 
United States   56   49   46   151 
South Africa   1   2   2   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Clinically Significant Bleeding   [ Time Frame: Up to Month 12 ]

2.  Secondary:   Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

3.  Secondary:   Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

4.  Secondary:   Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

5.  Secondary:   Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

6.  Secondary:   Percentage of Participants With Cardiovascular Death   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

7.  Secondary:   Percentage of Participants With Myocardial Infarction   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

8.  Secondary:   Percentage of Participants With Stroke   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]

9.  Secondary:   Percentage of Participants With Stent Thrombosis   [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
First the stratification to either 1, 6 or 12 months of DAPT was based upon clinician choice and was not randomized. Secondly there was not sufficient power to definitively assess efficacy due to the modest number of adverse CV events.


  More Information
  Hide 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: Senior Director Clinical Development
Organization: Janssen Scientific Affairs, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


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

Responsible Party: Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT01830543     History of Changes
Other Study ID Numbers: CR100758
RIVAROXAFL3003 ( Other Identifier: Janssen Scientific Affairs, LLC )
2012-001491-11 ( EudraCT Number )
First Submitted: March 19, 2013
First Posted: April 12, 2013
Results First Submitted: June 30, 2017
Results First Posted: July 31, 2017
Last Update Posted: September 19, 2017