Trial record 1 of 4 for:
PIONEER AF-PCI
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)
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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. |
| ClinicalTrials.gov Identifier: NCT01830543 |
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Recruitment Status :
Completed
First Posted : April 12, 2013
Results First Posted : July 31, 2017
Last Update Posted : September 19, 2017
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Sponsor:
Janssen Scientific Affairs, LLC
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Scientific Affairs, LLC
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Percutaneous Coronary Intervention | 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 | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2124 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 10, 2013 |
| Actual Primary Completion Date : | July 28, 2016 |
| Actual Study Completion Date : | July 28, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Familial atrial fibrillation
| Arm | Intervention/treatment |
|---|---|
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Experimental: rivaroxaban 2.5 mg twice daily
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
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Drug: rivaroxaban 2.5 mg
One 2.5 mg tablet twice daily for up to twelve months Drug: rivaroxaban 15 mg One 15 mg tablet once daily for up to twelve months Drug: rivaroxaban 10 mg One 10 mg tablet once daily for up to twelve months Drug: aspirin (ASA) Low-dose aspirin tablet once daily for twelve months Drug: clopidogrel One 75 mg tablet once daily for up to twelve months Drug: prasugrel One 10 mg tablet once daily for up to twelve months Drug: ticagrelor One 90 mg tablet twice daily for up to twelve months |
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Experimental: vitamin K antagonist (VKA)
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
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Drug: aspirin (ASA)
Low-dose aspirin tablet once daily for twelve months Drug: vitamin K antagonist (VKA) Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months Drug: clopidogrel One 75 mg tablet once daily for up to twelve months Drug: prasugrel One 10 mg tablet once daily for up to twelve months Drug: ticagrelor One 90 mg tablet twice daily for up to twelve months |
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Experimental: rivaroxaban 15 mg once daily
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
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Drug: rivaroxaban 15 mg
One 15 mg tablet once daily for up to twelve months Drug: rivaroxaban 10 mg One 10 mg tablet once daily for up to twelve months Drug: clopidogrel One 75 mg tablet once daily for up to twelve months Drug: prasugrel One 10 mg tablet once daily for up to twelve months Drug: ticagrelor One 90 mg tablet twice daily for up to twelve months |
Primary Outcome Measures :
- Percentage of Participants With Clinically Significant Bleeding [ Time Frame: Up to Month 12 ]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.
Secondary Outcome Measures :
- 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 ]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).
- 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 ]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).
- Percentage of Participants With Bleeding Requiring Medical Attention (BRMA) [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]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.
- 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 ]Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed.
- Percentage of Participants With Cardiovascular Death [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]The percentage of participants with the first occurrence of cardiovascular death were evaluated.
- Percentage of Participants With Myocardial Infarction [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]The percentage of participants with the first occurrence of Myocardial Infarction were evaluated.
- Percentage of Participants With Stroke [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]The percentage of participants with the first occurrence of Stroke were evaluated.
- Percentage of Participants With Stent Thrombosis [ Time Frame: Up to Month 12 and end of DAPT-Month 1, 6 and 12 ]The percentage of participants with the first occurrence of stent thrombosis were evaluated.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830543
Locations
Show 356 study locations
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Bayer
Investigators
| Study Director: | Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Janssen Scientific Affairs, LLC |
| ClinicalTrials.gov Identifier: | NCT01830543 |
| Other Study ID Numbers: |
CR100758 RIVAROXAFL3003 ( Other Identifier: Janssen Scientific Affairs, LLC ) 2012-001491-11 ( EudraCT Number ) |
| First Posted: | April 12, 2013 Key Record Dates |
| Results First Posted: | July 31, 2017 |
| Last Update Posted: | September 19, 2017 |
| Last Verified: | August 2017 |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Janssen Scientific Affairs, LLC:
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Atrial Fibrillation Irregular heart beat rivaroxaban aspirin |
clopidogrel prasugrel ticagrelor vitamin K antagonist |
Additional relevant MeSH terms:
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Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Aspirin Vitamin K Rivaroxaban Clopidogrel Ticagrelor Prasugrel Hydrochloride Vitamins Micronutrients Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists |