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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016873 |
Receipt No. | R000019429 |
Scientific Title | Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS) |
Date of disclosure of the study information | 2015/03/23 |
Last modified on | 2018/04/17 |
Basic information | ||
Public title | Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS) | |
Acronym | REWRAPS Study | |
Scientific Title | Registry for Estimation of Warfarin and Rivaroxaban in Atrial Fibrillation Patients With Coronary Stent Implantation (REWRAPS) | |
Scientific Title:Acronym | REWRAPS Study | |
Region |
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Condition | ||
Condition | Atrial fibrillation, Coronary artery disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the hypothesis that Rivaroxaban is non-inferior to Warfarin in the efficacy and safety for AF patients after coronary stenting |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | 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 |
Key secondary outcomes | 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 |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Rivaroxaban | |
Interventions/Control_2 | Warfarin | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key 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 |
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Key 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 |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Fujita Health University | ||||||
Division name | Cardiology | ||||||
Zip code | |||||||
Address | 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192 | ||||||
TEL | 0562-93-2312 | ||||||
ozakiyuk@fujita-hu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Fujita Health University | ||||||
Division name | Cardiology | ||||||
Zip code | |||||||
Address | 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, 470-1192 | ||||||
TEL | 0562-93-2312 | ||||||
Homepage URL | |||||||
hkawai@fujita-hu.ac.jp |
Sponsor | |
Institute | Fujita Health University, Department of Cardiology |
Institute | |
Department |
Funding Source | |
Organization | Fujita Health University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019429 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |