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Anticoagulant

rivaroxaban 2.5 mg twice daily for Atrial Fibrillation (PIONEER AF-PCI Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Scientific Affairs, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12 and end of dapt-month 1, 6 and 12
Awards & highlights
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
Pivotal Trial

Summary

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).

Eligible Conditions
  • Atrial Fibrillation
  • Percutaneous Coronary Intervention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12 and end of dapt-month 1, 6 and 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 and end of dapt-month 1, 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemorrhage
Secondary study objectives
Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
Percentage of Participants With Cardiovascular Death
Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
+5 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Group I: vitamin K antagonist (VKA)Experimental Treatment5 Interventions
dose-adjusted vitamin K antagonist (VKA) once daily (target International Normalized Ratio (INR) 2.0 to 3.0) plus low-dose ASA, 75 to 100 mg per day, and clopidogrel 75 mg once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by dose-adjusted VKA once daily (target INR 2.0 to 3.0 or 2.0 to 2.5 at the investigator discretion) plus low-dose ASA for 12 months
Group II: rivaroxaban 2.5 mg twice dailyExperimental Treatment7 Interventions
rivaroxaban 2.5 mg tablet twice daily plus low-dose aspirin (ASA) 75 to 100 mg once daily and clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) followed by rivaroxaban 15 mg tablet (or 10 mg for subjects with moderate renal impairment) once daily plus low-dose ASA for 12 months
Group III: rivaroxaban 15 mg once dailyExperimental Treatment5 Interventions
rivaroxaban 15 mg (or 10 mg for subjects with moderate renal impairment) once daily plus clopidogrel 75 mg tablet once daily (or prasugrel 10 mg tablet once daily or ticagrelor 90 mg tablet twice daily) for 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clopidogrel
FDA approved
Prasugrel
FDA approved
Ticagrelor
FDA approved
Rivaroxaban
FDA approved
Rivaroxaban
FDA approved
Rivaroxaban
FDA approved
Acetylsalicylic acid
FDA approved
Phylloquinone
FDA approved

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCLead Sponsor
163 Previous Clinical Trials
577,839 Total Patients Enrolled
17 Trials studying Atrial Fibrillation
480,499 Patients Enrolled for Atrial Fibrillation
BayerIndustry Sponsor
2,270 Previous Clinical Trials
25,506,608 Total Patients Enrolled
95 Trials studying Atrial Fibrillation
2,268,876 Patients Enrolled for Atrial Fibrillation
Janssen Scientific Affairs, LLC Clinical TrialStudy DirectorJanssen Scientific Affairs, LLC
36 Previous Clinical Trials
84,099 Total Patients Enrolled
6 Trials studying Atrial Fibrillation
60,584 Patients Enrolled for Atrial Fibrillation
~171 spots leftby Oct 2025
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