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Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillation

Prospective randomized study of safety outcomes treated with edoxaban in patients with stable coronary artery disease and atrial fibrillation - PRAEDO AF study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032030
Enrollment
200
Registered
2018-03-31
Start date
2018-06-01
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

Non-valvular atrial fibrillation

Interventions

Edoxaban monotherapy Edoxaban will be orally administered at a dose of 30 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 30 mg if the CLcr is 15-50 mL/min and at a dose

Sponsors

Nihon university school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with non-valvular atrial fibrillation complicated with stable coronary artery disease who are 20 years or more at the obtaining of informed consent, CHADS2 score are 1 or more, and fulfil the criteria below and can provide written consent for participation in the present study will be eligible. 1) Patients who underwent percutaneous coronary intervention, including plain old balloon angioplasty, at least six months ago 2) Patients who have coronary stenosis requiring no percutaneous coronary intervention (50% or more stenosis) as indicated by coronary CT or coronary angiography 3) Patients who underwent coronary artery bypass graft CABG at least six months ago

Exclusion criteria

Exclusion criteria: 1)Patients who are contraindicated for edoxaban 2)Patients who are contraindicated for clopidogrel 3)Patients who are going to undergo revascularization 4)Those who are going to undergo invasive surgery (excluding digestive endoscopy and biopsy) 5)Patients who have active tumors 6)Patients who have poorly-controlled hypertension (systolic blood pressure at hospital admission: 160 mmHg or more) 7)Patients judged as inappropriate for this study by investigators

Design outcomes

Primary

MeasureTime frame
major bleeding Clinically relevant non-major bleeding

Countries

Japan

Contacts

Public ContactDaisuke Fukamachi

Nihon university school of medicine department of cardiology

fukamachi.daisuke@nihon-u.ac.jp03-3972-8111

Outcome results

None listed

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