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

Atrial Fibrillation Clinical Trial

— PIONEER AF-PCI  

Official title:

An 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830543
• Other study ID #: CR100758
• Secondary ID: RIVAROXAFL300320
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2013
• Last updated: August 21, 2017
• Start date: May 10, 2013
• Est. completion date: July 28, 2016

Study information

• Verified date: August 2017
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2124
• Est. completion date: July 28, 2016
• Est. primary completion date: July 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Women must be postmenopausal before entry or practicing a highly effective method of birth control when heterosexually active

• Be willing and able to adhere to the prohibitions and restrictions specified in the study protocol

Exclusion Criteria:

• 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

• Have anemia of unknown cause with a hemoglobin level <10 g/dL (<6.21 mmol/L)

• Have a history of stroke or Transient Ischemic Attack (TIA)

• Have a calculated Creatinine Clearance (CrCl) <30 mL/min at screening

• Have known significant liver disease or liver function test (LFT) abnormalities

• Have any severe condition that would limit life expectancy to less than 12 months

Related Conditions & MeSH terms

• Atrial Fibrillation
• Percutaneous Coronary Intervention

Intervention

Drug:
• rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months
• rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months
• rivaroxaban 10 mg
One 10 mg tablet once daily for up to twelve months
• aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months
• vitamin K antagonist (VKA)
Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
• clopidogrel
One 75 mg tablet once daily for up to twelve months
• prasugrel
One 10 mg tablet once daily for up to twelve months
• ticagrelor
One 90 mg tablet twice daily for up to twelve months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC	Bayer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Czechia,  Denmark,  France,  Germany,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Poland,  Romania,  Russian Federation,  South Africa,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinically Significant Bleeding	Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.	Up to Month 12
Secondary	Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding	TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent).	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding	TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent).	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)	A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)	Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Cardiovascular Death	The percentage of participants with the first occurrence of cardiovascular death were evaluated.	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Myocardial Infarction	The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Stroke	The percentage of participants with the first occurrence of Stroke were evaluated.	Up to Month 12 and end of DAPT-Month 1, 6 and 12
Secondary	Percentage of Participants With Stent Thrombosis	The percentage of participants with the first occurrence of stent thrombosis were evaluated.	Up to Month 12 and end of DAPT-Month 1, 6 and 12