Atrial FibrillationPhase 4AFIRENCT02642419
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study
A Phase 4 study testing Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel) and Rivaroxaban in people with Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
Trial summary
In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD), antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and cardiovascular events in combination with anticoagulant drugs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel) and Rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or older, with CHADS2 score are ≧1 , and that fulfill one of the following criteria and can provide written consent for participation in the present study will be eligible.
- Patients who underwent percutaneous coronary intervention(PCI), including plain old balloon angioplasty(POBA), at least one year ago
- Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography(CAG)
- Patients who underwent coronary artery bypass graft (CABG) at least one year ago
Who cannot join
- Patients for whom rivaroxaban is contraindicated
- Patients for whom aspirin, thienopyridine derivatives (clopidogrel or prasugrel) are contraindicated
- Patients who underwent PCI, including POBA, in the past one year
- Patients who are going to undergo revascularization
- Patients who have a past history of stent thrombosis
- Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy)
Show all 10Show fewer
- Patients who have active tumors
- Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission: 160 mmHg or more)
- Patients who cannot discontinue treatment with antiplatelet drugs (the physician in charge will make a decision on the basis of the lesion shape, lesion site and type of stents.)
- Patients judged as inappropriate for this study by investigators
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Japan Cardiovascular Research Foundation
Suita, Osaka, 565-8565
Hisao Ogawa, +81-6-6833-8706, ogawah@ncvc.go.jp
Hisao Ogawa, M.D.
About this study
Official title: Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study (AFIRE Study)
In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD), antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and cardiovascular events in combination with anticoagulant drugs. Based on the observations that the incidence of hemorrhagic complications increased when an antiplatelet drug was administered in combination with vitamin K antagonist (VKA), the guidelines for antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets therapy) should be used in AF-complicated CAD patients for as short a time as possible following single anti-platelet and VKA, and that monotherapy with VKA should be started from one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug therapy with a NOACs in stable CAD patients one year or more after PCI.
AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction (MI).
Read the detailed description
Study Design:prospective, randomized, open-label trial
Allocation:ratio to rivaroxaban monotherapy and rivaroxaban in co-administration with a single anti-platelet therapy is 1: 1 using WEB system
- Conditions
- Atrial Fibrillation
- Being tested
- Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel), Rivaroxaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel)Drug
- Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time)
- Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel)
- Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg
- Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day depending on age, body weight or clinical findings.
- Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less a reduced dose(2.5 mg once a day) will be considered depending on the age, renal function or other bleeding and thrombotic risk.
RivaroxabanDrug
Rivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban | Experimental | Not described Receives: Drug: Rivaroxaban |
| Rivaroxaban and single antiplatelet drug | Experimental | Not described Receives: Drug: Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of cardiovascular events
stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality
Measured: mean duration: 2 years, maximum duration: 3 years
Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Measured: mean duration: 2 years, maximum duration: 3 years
Secondary outcomes (13)
Net adverse clinical and cerebral events (NACCE)
composite of all-cause death, myocardial infarction, stroke and major bleeding.
Measured: mean duration: 2 years, maximum duration: 3 years
Ischemic cardiovascular events and death
- All-cause mortality
- Cardiovascular death
- non-cardiovascular death
- Myocardial infarction
- Unstable angina pectoris requiring revascularization
- Ischemic stroke
- Transient ischemic attack
- non-CNS embolism (systemic embolism pulmonary embolism, deep vein thrombosis)
- PCI/CABG
- Stent thrombosis
- Ischemic stroke and systemic embolism
Measured: mean duration: 2 years, maximum duration: 3 years
All bleeding events
Measured: mean duration: 2 years, maximum duration: 3 years
Adverse events excluding hemorrhagic events
Measured: mean duration: 2 years, maximum duration: 3 years
Comparison of the primary endpoints, ischemic cardiovascular events and mortality between patients treated with aspirin and patients treated with thienopyridine derivatives
Measured: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of primary endpoints, ischemic cardiovascular events and mortality according to the CHADS2 score and CHA2DS2-VASc score
Measured: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of primary endpoints, ischemic cardiovascular events and mortality according to subject characteristics
Measured: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of major bleeding and all bleeding events according to the HAS-BLED score in patients with and without co-administration of antiplatelet drug and analysis of specificity and sensitivity
Measured: mean duration: 2 years, maximum duration: 3 years
Comparison of the incidence of bleeding events according to whether or not proton pump inhibitors (PPIs) are used
Measured: mean duration: 2 years, maximum duration: 3 years
Comparison of the incidence of the primary endpoints according to whether rivaroxaban is administered in the morning or evening
Primary endpoints include the composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularization or cardiovascular death) and major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria.
Measured: mean duration: 2 years, maximum duration: 3 years
Correlation of discontinuation of antithrombotic agents with ischemic cardiovascular events, bleeding events and adverse events
Measured: mean duration: 2 years, maximum duration: 3 years
Correlation of prothrombin time at trough with bleeding events and evaluation of the cutoff values in patients with and without co-administration of antiplatelet drug
Measured: mean duration: 2 years, maximum duration: 3 years
The incidence of the primary endpoints according to different rates of adherence
Primary endpoints include the composite endpoint of cardiovascular events (stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularization or cardiovascular death) and major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria.
The rate of adherence will be calculated by dividing the number of prescribed tablets by the period of treatment: e.g., if 240 tablets are prescribed for 300 days, the rate of adherence will be 80.0% (240/300).
Measured: mean duration: 2 years, maximum duration: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Japan Cardiovascular Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hisao Ogawa, Principal investigator, Japan Cardiovascular Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642419
- Sponsor's protocol ID
- AFIRE Study
- Acronym
- AFIRE
- Status last verified
- Dec 2015
- First submitted
- 21 Oct 2015
- Last updated
- 30 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamaguchi J, Arashi H, Hagiwara N, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Matsui K, Ogawa H; AFIRE Investigators. Age-Stratified Effect of Rivaroxaban Monotherapy for Atrial Fibrillation in Stable Coronary Artery Disease: A Post Hoc Analysis of the AFIRE Randomized Clinical Trial. JAMA Cardiol. 2025 Aug 13;10(10):990-9. doi: 10.1001/jamacardio.2025.2611. Online ahead of print.
PubMed 40802193Iijima R, Tokue M, Nakamura M, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Thrombocytopenia as a Bleeding Risk Factor in Atrial Fibrillation and Coronary Artery Disease: Insights From the AFIRE Study. J Am Heart Assoc. 2023 Oct 17;12(20):e031096. doi: 10.1161/JAHA.123.031096. Epub 2023 Oct 10.
PubMed 37815031Ishii M, Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Nishihara E, Nakamura S, Matsui K, Ogawa H, Tsujita K; AFIRE Investigators. Risk prediction score for clinical outcome in atrial fibrillation and stable coronary artery disease. Open Heart. 2023 May;10(1):e002292. doi: 10.1136/openhrt-2023-002292.
PubMed 37173099Ishii M, Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H, Tsujita K; AFIRE Investigators. Rivaroxaban Monotherapy in Atrial Fibrillation and Stable Coronary Artery Disease Across Body Mass Index Categories. JACC Asia. 2022 Aug 27;2(7):882-893. doi: 10.1016/j.jacasi.2022.08.004. eCollection 2022 Dec.
PubMed 36713761Naito R, Miyauchi K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Rivaroxaban Monotherapy vs Combination Therapy With Antiplatelets on Total Thrombotic and Bleeding Events in Atrial Fibrillation With Stable Coronary Artery Disease: A Post Hoc Secondary Analysis of the AFIRE Trial. JAMA Cardiol. 2022 Aug 1;7(8):787-794. doi: 10.1001/jamacardio.2022.1561.
PubMed 35704345Arashi H, Yamaguchi J, Hagiwara N, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE investigators. Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings. Thromb Haemost. 2022 Sep;122(9):1584-1593. doi: 10.1055/s-0042-1744543. Epub 2022 Jun 13.
PubMed 35697255Matsui K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Ogawa H. The impact of kidney function in patients on antithrombotic therapy: a post hoc subgroup analysis focusing on recurrent bleeding events from the AFIRE trial. BMC Med. 2022 Feb 25;20(1):69. doi: 10.1186/s12916-022-02268-6.
PubMed 35209924Matoba T, Yasuda S, Kaikita K, Akao M, Ako J, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2330-2340. doi: 10.1016/j.jcin.2021.07.045.
PubMed 34736731Matsuzawa Y, Kimura K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Antithrombotic Therapy for Atrial Fibrillation and Coronary Artery Disease in Patients With Prior Atherothrombotic Disease: A Post Hoc Analysis of the AFIRE Trial. J Am Heart Assoc. 2021 Nov 2;10(21):e020907. doi: 10.1161/JAHA.121.020907. Epub 2021 Oct 18.
PubMed 34658247Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e010476. doi: 10.1161/CIRCINTERVENTIONS.120.010476. Epub 2021 Sep 3.
PubMed 34474583Fukaya H, Ako J, Yasuda S, Kaikita K, Akao M, Matoba T, Nakamra M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Aspirin versus P2Y12 inhibitors with anticoagulation therapy for atrial fibrillation. Heart. 2021 Nov;107(21):1731-1738. doi: 10.1136/heartjnl-2021-319321. Epub 2021 Jul 14.
PubMed 34261738Akao M, Yasuda S, Kaikita K, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Rivaroxaban monotherapy versus combination therapy according to patient risk of stroke and bleeding in atrial fibrillation and stable coronary disease: AFIRE trial subanalysis. Am Heart J. 2021 Jun;236:59-68. doi: 10.1016/j.ahj.2021.02.021. Epub 2021 Feb 28.
PubMed 33657403Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease. N Engl J Med. 2019 Sep 19;381(12):1103-1113. doi: 10.1056/NEJMoa1904143. Epub 2019 Sep 2.
PubMed 31475793
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study (AFIRE Study)
- ClinicalTrials.gov ID
- NCT02642419
- Acronym / sponsor ID
- AFIRE / AFIRE Study
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Japan Cardiovascular Research FoundationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In patients with atrial fibrillation (AF) complicated with coronary artery disease (CAD), antiplatelet drugs are commonly used for the prevention of recurrence of stent thrombosis and cardiovascular events in combination with anticoagulant drugs. Based on the observations that the incidence of hemorrhagic complications increased when an antiplatelet drug was administered in combination with vitamin K antagonist (VKA), the guidelines for antithrombotic therapy after PCI in the US and EU recommend that DAPT (dual anti-platelets therapy) should be used in AF-complicated CAD patients for as short a time as possible following single anti-platelet and VKA, and that monotherapy with VKA should be started from one year after PCI. In 2013 the European Heart Rhythm Association (EHRA) published the guidelines for the use of NOACs in NVAF patients, which state that NOACs may have advantage to VKAs in terms of anti-thrombotic effects in NVAF patients undergoing PCI. However, no clinical evidence has ever been generated to reveal the efficacy and safety of mono-drug therapy with a NOACs in stable CAD patients one year or more after PCI.
AFIRE study is planned to evaluate the efficacy and safety of mono-drug therapy with a rivaroxaban in stable CAD patients. Among NOACs, rivaroxaban was chosen because of the evidence in Japanese patients and the results of a sub-analysis of ROCKET AF suggesting that rivaroxaban is more effective than VKA in reducing the incidence of myocardial infarction (MI).
Detailed description
Study Design:prospective, randomized, open-label trial
Allocation:ratio to rivaroxaban monotherapy and rivaroxaban in co-administration with a single anti-platelet therapy is 1: 1 using WEB system
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: Rivaroxaban |
| Rivaroxaban and single antiplatelet drug | Experimental | Drug: Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or older, with CHADS2 score are ≧1 , and that fulfill one of the following criteria and can provide written consent for participation in the present study will be eligible.
- Patients who underwent percutaneous coronary intervention(PCI), including plain old balloon angioplasty(POBA), at least one year ago
- Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography(CAG)
- Patients who underwent coronary artery bypass graft (CABG) at least one year ago
Key exclusion criteria (10 listed)
- Patients for whom rivaroxaban is contraindicated
- Patients for whom aspirin, thienopyridine derivatives (clopidogrel or prasugrel) are contraindicated
- Patients who underwent PCI, including POBA, in the past one year
- Patients who are going to undergo revascularization
- Patients who have a past history of stent thrombosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel)* Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time) * Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel) * Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg * Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day depending on age, body weight or clinical findings. * Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less a reduced dose(2.5 mg once a day) will be considered depending on the age, renal function or other bleeding and thrombotic risk. | Drug | Rivaroxaban and single antiplatelet drug |
| RivaroxabanRivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min. | Drug | Rivaroxaban |
Primary outcome
Composite endpoint of cardiovascular events
Time frame: mean duration: 2 years, maximum duration: 3 years
stroke, non-CNS embolism, myocardial infarction, unstable angina pectoris requiring revascularizations or all-cause mortality
Major bleeding defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria
Time frame: mean duration: 2 years, maximum duration: 3 years
13 secondary outcomes
Net adverse clinical and cerebral events (NACCE)
Time frame: mean duration: 2 years, maximum duration: 3 years
Ischemic cardiovascular events and death
Time frame: mean duration: 2 years, maximum duration: 3 years
All bleeding events
Time frame: mean duration: 2 years, maximum duration: 3 years
Adverse events excluding hemorrhagic events
Time frame: mean duration: 2 years, maximum duration: 3 years
Comparison of the primary endpoints, ischemic cardiovascular events and mortality between patients treated with aspirin and patients treated with thienopyridine derivatives
Time frame: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of primary endpoints, ischemic cardiovascular events and mortality according to the CHADS2 score and CHA2DS2-VASc score
Time frame: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of primary endpoints, ischemic cardiovascular events and mortality according to subject characteristics
Time frame: mean duration: 2 years, maximum duration: 3 years
Subgroup analysis of major bleeding and all bleeding events according to the HAS-BLED score in patients with and without co-administration of antiplatelet drug and analysis of specificity and sensitivity
Time frame: mean duration: 2 years, maximum duration: 3 years
Comparison of the incidence of bleeding events according to whether or not proton pump inhibitors (PPIs) are used
Time frame: mean duration: 2 years, maximum duration: 3 years
Comparison of the incidence of the primary endpoints according to whether rivaroxaban is administered in the morning or evening
Time frame: mean duration: 2 years, maximum duration: 3 years
Correlation of discontinuation of antithrombotic agents with ischemic cardiovascular events, bleeding events and adverse events
Time frame: mean duration: 2 years, maximum duration: 3 years
Correlation of prothrombin time at trough with bleeding events and evaluation of the cutoff values in patients with and without co-administration of antiplatelet drug
Time frame: mean duration: 2 years, maximum duration: 3 years
The incidence of the primary endpoints according to different rates of adherence
Time frame: mean duration: 2 years, maximum duration: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Derived from this study: PubMed 40802193Yamaguchi J, Arashi H, Hagiwara N, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Matsui K, Ogawa H; AFIRE Investigators. Age-Stratified Effect of Rivaroxaban Monotherapy for Atrial Fibrillation in Stable Coronary Artery Disease: A Post Hoc Analysis of the AFIRE Randomized Clinical Trial. JAMA Cardiol. 2025 Aug 13;10(10):990-9. doi: 10.1001/jamacardio.2025.2611. Online ahead of print.
- Derived from this study: PubMed 37815031Iijima R, Tokue M, Nakamura M, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Thrombocytopenia as a Bleeding Risk Factor in Atrial Fibrillation and Coronary Artery Disease: Insights From the AFIRE Study. J Am Heart Assoc. 2023 Oct 17;12(20):e031096. doi: 10.1161/JAHA.123.031096. Epub 2023 Oct 10.
- Derived from this study: PubMed 37173099Ishii M, Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Nishihara E, Nakamura S, Matsui K, Ogawa H, Tsujita K; AFIRE Investigators. Risk prediction score for clinical outcome in atrial fibrillation and stable coronary artery disease. Open Heart. 2023 May;10(1):e002292. doi: 10.1136/openhrt-2023-002292.
- Derived from this study: PubMed 36713761Ishii M, Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H, Tsujita K; AFIRE Investigators. Rivaroxaban Monotherapy in Atrial Fibrillation and Stable Coronary Artery Disease Across Body Mass Index Categories. JACC Asia. 2022 Aug 27;2(7):882-893. doi: 10.1016/j.jacasi.2022.08.004. eCollection 2022 Dec.
- Derived from this study: PubMed 35704345Naito R, Miyauchi K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Rivaroxaban Monotherapy vs Combination Therapy With Antiplatelets on Total Thrombotic and Bleeding Events in Atrial Fibrillation With Stable Coronary Artery Disease: A Post Hoc Secondary Analysis of the AFIRE Trial. JAMA Cardiol. 2022 Aug 1;7(8):787-794. doi: 10.1001/jamacardio.2022.1561.
- Derived from this study: PubMed 35697255Arashi H, Yamaguchi J, Hagiwara N, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE investigators. Rivaroxaban Underdose for Atrial Fibrillation with Stable Coronary Disease: The AFIRE Trial Findings. Thromb Haemost. 2022 Sep;122(9):1584-1593. doi: 10.1055/s-0042-1744543. Epub 2022 Jun 13.
- Derived from this study: PubMed 35209924Matsui K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Ogawa H. The impact of kidney function in patients on antithrombotic therapy: a post hoc subgroup analysis focusing on recurrent bleeding events from the AFIRE trial. BMC Med. 2022 Feb 25;20(1):69. doi: 10.1186/s12916-022-02268-6.
- Derived from this study: PubMed 34736731Matoba T, Yasuda S, Kaikita K, Akao M, Ako J, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial. JACC Cardiovasc Interv. 2021 Nov 8;14(21):2330-2340. doi: 10.1016/j.jcin.2021.07.045.
- Derived from this study: PubMed 34658247Matsuzawa Y, Kimura K, Yasuda S, Kaikita K, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Hirayama A, Matsui K, Ogawa H; AFIRE Investigators. Antithrombotic Therapy for Atrial Fibrillation and Coronary Artery Disease in Patients With Prior Atherothrombotic Disease: A Post Hoc Analysis of the AFIRE Trial. J Am Heart Assoc. 2021 Nov 2;10(21):e020907. doi: 10.1161/JAHA.121.020907. Epub 2021 Oct 18.
- Derived from this study: PubMed 34474583Kaikita K, Yasuda S, Akao M, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Bleeding and Subsequent Cardiovascular Events and Death in Atrial Fibrillation With Stable Coronary Artery Disease: Insights From the AFIRE Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e010476. doi: 10.1161/CIRCINTERVENTIONS.120.010476. Epub 2021 Sep 3.
- Derived from this study: PubMed 34261738Fukaya H, Ako J, Yasuda S, Kaikita K, Akao M, Matoba T, Nakamra M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Aspirin versus P2Y12 inhibitors with anticoagulation therapy for atrial fibrillation. Heart. 2021 Nov;107(21):1731-1738. doi: 10.1136/heartjnl-2021-319321. Epub 2021 Jul 14.
- Derived from this study: PubMed 33657403Akao M, Yasuda S, Kaikita K, Ako J, Matoba T, Nakamura M, Miyauchi K, Hagiwara N, Kimura K, Hirayama A, Matsui K, Ogawa H. Rivaroxaban monotherapy versus combination therapy according to patient risk of stroke and bleeding in atrial fibrillation and stable coronary disease: AFIRE trial subanalysis. Am Heart J. 2021 Jun;236:59-68. doi: 10.1016/j.ahj.2021.02.021. Epub 2021 Feb 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hisao Ogawa principal investigator
Japan Cardiovascular Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel) and Rivaroxaban in people with Atrial Fibrillation, run by Japan Cardiovascular Research Foundation at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saburo Saito (+81-6-6872-0010, afire@jcvrf.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of cardiovascular events (time frame: mean duration: 2 years, maximum duration: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642419, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.