Completed

PIONEER AF-PCIAn Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

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What is being tested

rivaroxaban 2.5 mg

+ rivaroxaban 15 mg

+ rivaroxaban 10 mg

Drug
Who is being recruted

Cardiovascular Diseases+3

+ Heart Diseases

+ Pathologic Processes

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorJanssen Scientific Affairs, LLC
Last updated: September 19, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: May 10, 2013

Actual date on which the first participant was enrolled.

This is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and one vitamin K antagonist (VKA) treatment strategy in participants, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and have had a percutaneous coronary intervention (PCI) with stent placement. A target of 2,100 participants will be randomized into the study, with approximately 700 participants in each treatment strategy group. The randomization will be stratified by the intended duration of DAPT (1, 6, or 12 months). The study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. The total duration of participation in the study for each participant is approximately 12 months.

NCT01830543
Principal SponsorJanssen Scientific Affairs, LLC
Last updated: September 19, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacAtrial Fibrillation

Criteria

5 inclusion criteria required to participate
Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol
Have a documented medical history of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)
Have undergone percutaneous coronary intervention (PCI) procedure (with stent placement) for primary atherosclerotic disease
Must have an international normalized ratio (INR) of 2.5 or below to be randomized
Show More Criteria
6 exclusion criteria prevent from participating
Have a calculated Creatinine Clearance (CrCl) < 30 mL/min at screening
Have a history of stroke or Transient Ischemic Attack (TIA)
Have anemia of unknown cause with a hemoglobin level < 10 g/dL ( < 6.21 mmol/L)
Have any condition that contraindicates anticoagulant or antiplatelet therapy or would have an unacceptable risk of bleeding, such as, but not limited to: platelet count < 90,000/microliter at screening, history of intracranial hemorrhage, 12 month history of clinically significant gastrointestinal bleeding, non-VKA induced elevated prothrombin time (PT) at screening
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

Experimental
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 III

Experimental
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 348 locations

Huntsville, United StatesOpen in Google Maps

Los Alamitos, United States

Mission Viejo, United States

Oceanside, United States
Completed348 Study Centers