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Completed

NCT Number: NCT02024230

Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS)

Antiplatelet therapy is indispensable for the prevention of stent thrombosis in patients who underwent coronary artery stenting. Similarly, anticoagulant therapy is essential for the prevention of cardiogenic embolism including cerebral infarction in AF patients. However, the combined antithrombotic therapy has been reported to increase the risk of major bleeding for AF patients after coronary stenting, New anticoagulant drugs that hardly interact with other drugs and do not need frequent blood tests have become commonly used. The purpose of this study is to assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting

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Key information

Conditions

Coronary Artery Disease All Cause Mortality Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Fetal Blood Loss Heart Diseases Major Bleeding Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yukio Ozaki

Nagoya, Aichi-ken, 461-0021, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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 are not willing to participate in the study.

Treatment and study plan

Rivaroxaban or Warfarin

Drug

a multi-center, prospective, non-randomized, open-label, physician-initiated interventional allocation study either rivaroxaban or warfarin

Primary outcomes

  1. a composite of adverse events

    Time frame: 3 years

    cardiac or stroke death, non-fatal myocardial infarction, non-fatal stroke, coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft), and systemic embolism

  2. major bleeding

    Time frame: 3 years

    BARC 3 and 5

  3. Net Adverse Clinical Event (NACE)

    Time frame: 3 years

    a composite of all-cause death and major bleeding

Secondary outcomes

  1. all-cause death

    Time frame: 3 years

  2. admission due to congestive heart failure

    Time frame: 3 years

  3. fatal arrhythmia

    Time frame: 3 years

  4. electrocardiographic findings

    Time frame: 3 years

    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)

  5. cardiac ultrasound findings

    Time frame: 3 years

    left atrial dilatation (LAD), left ventricular end-diastolic diameter (LVDd), left ventricular end-systolic diameter (LVDs), E/A, E/E', tricuspid regurgitation pressure gradient (TRPG), LV wall abnormality

  6. each cardiovascular event used for the primary efficacy outcome measures

    Time frame: 3 years

  7. non-major clinical relevant bleeding

    Time frame: 3 years

  8. cardiac or stroke death

    Time frame: 3 years

  9. non-fatal myocardial infarction

    Time frame: 3 years

  10. non-fatal stroke

    Time frame: 3 years

  11. coronary artery revascularization (percutaneous coronary intervention or coronary artery bypass graft)

    Time frame: 3 years

  12. systemic embolism

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fujita Health University

Other

Registry information

Acronym: REWRAPS

Important dates

Study start
2014
Primary completion
2018
Study completion
2022
First posted
Dec 31, 2013
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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