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Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS)

Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS) - REWRAPS Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016873
Enrollment
300
Registered
2015-03-23
Start date
2014-01-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, Coronary artery disease

Interventions

Sponsors

Fujita Health University, Department of Cardiology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Clinically stable atrial fibrillation (AF) patients who underwent coronary artery stenting more than one year ago and are treated or are scheduled to be treated with anticoagulant drug (regardless of the type of stents and AF) Those who are willing to cooperate with us in the study Those who can sign the informed consent document that is approved by the ethics committee of the medical institution participating in the study

Exclusion criteria

Exclusion criteria: Those in whom the package inserts state anticoagulant drugs are contraindicated for use Those who are scheduled to undergo percutaneous coronary intervention or catheter ablation for AF Those who have to continuously undergo dual antiplatelet due to a past history of stent thrombosis during the distant stage after stenting Those who have undergone prosthetic valve replacement for valvular disease Those who the physician in charge judges are ineligible for the study due to serious pathological conditions Those who have moderate renal insufficiency (creatinine clearance less than 30 ml/min) Those who have severe hepatic insufficiency [ALT more than five times the upper limit of normal (ULN), or ALT more than three times ULN, plus total bilirubin more than three times ULN] Those who have anemia (hemoglobin less than 10 g/dl) Those who are not willing to participate in the study

Design outcomes

Primary

MeasureTime frame
Efficacy; composite of adverse events [cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, and coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism] Safety; major bleeding or non-major clinically relevant bleeding

Secondary

MeasureTime frame
All-cause death non-fatal myocardial infarction coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft) admission due to congestive heart failure fatal arrhythmia non-fatal stroke systemic embolism stent thrombosis major bleeding non-major clinical relevant bleeding electrocardiographic findings rhythm, ST change, Q wave abnormality, QRS duration, QT interval, QTc interval, the presence of supraventricular premature contraction (SVPC), the presence of ventricular premature contraction (VPC) cardiac ultrasound findings left atrial dilatation (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), E/A, tricuspid regurgitation pressure gradient (TRPG), LV wall abnormality

Countries

Japan

Contacts

Public ContactHideki Kawai

Fujita Health University Cardiology

hkawai@fujita-hu.ac.jp0562-93-2312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026