Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

Phase 4

Completed

• Conditions: Stable Chronic Angina; Atrial Fibrillation; Coronary Artery Disease; Stable Angina
• Interventions: Drug: Edoxaban Monotherapy; Drug: Edoxaban plus Single Antiplatelet Agent

• Registration Number: NCT03718559
• Lead Sponsor: Gi-Byoung Nam

Brief Summary

This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD \[≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD\]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-05-14
• Primary Completion: 2023-11-08
• Study Completion: 2023-11-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1040

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edoxaban alone	Edoxaban Monotherapy	-
Combination of edoxaban plus single antiplatelet	Edoxaban plus Single Antiplatelet Agent	-

Primary Outcome Measures

Name	Time	Method
Rate of net Clinical Outcome	1 year	composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of a major coronary artery, major bleeding, and clinically relevant non-major bleeding event

Secondary Outcome Measures

Name	Time	Method
Rate of major bleeding	1 year	ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Rate of systemic embolism	1 year
Rate of unplanned revascularization	1 year
Rate of stent thrombosis	1 year
Rate of all cause death	1 year
Rate of cardiovascular death	1 year
Rate of composite of hard outcomes	1 year	all cause death, myocardial infarction, ischemic stroke, and systemic embolism
Rate of intracranial hemorrhage	1 year
Rate of composite of Major or clinically relevant non-major bleeding	1 year	1. Major bleeding; * Fatal bleeding; * Bleeding in the critical site (Intracranial, retroperitoneal, intraocular, intraspinal, intra-articular, pericardial, intramuscular with compartment syndrome); * Bleeding causing a fall in haemoglobin level of 2g/dL or leading to transfusion of two or more units of whole blood or red cells.; 2. Clinically relevant non-major bleeding; defined as any sign or symptom of haemorrhage that does not fit the criteria for The International Society on Thrombosis and Haemostasis (ISTH) major bleeding but requiring medical intervention, leading to hospitalization, or prompting a medical evaluation. Specifically bleeding that meet one of following criteria.; * bleeding that resulted in hospitalization; * medical or surgical intervention for bleeding; * an unscheduled clinic visit, or; * a change in physician-directed antithrombotic therapy.
Rate of fatal bleeding	1 year	International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
Rate of gastrointestinal hemorrhage	1 year
Rate of myocardial infarction	1 year
Rate of ischemic stroke	1 year
Rate of minor bleeding	1 year	ISTH, BARC and TIMI criteria

Trial Locations

Locations (18)

Soon Chun Hyang University Hospital Bucheon; 🇰🇷 Bucheon, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Dong-A University Hospital; 🇰🇷 Pusan, Korea, Republic of

The Catholic University of Korea, St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of

Kangdong KyungHee University hospital; 🇰🇷 Seoul, Korea, Republic of

VHS medical center; 🇰🇷 Seoul, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Hallym University Medical Center; 🇰🇷 Anyang, Korea, Republic of

The Catholic Univ. of Korea, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Dongguk University Ilsan Hospital; 🇰🇷 Ilsan, Korea, Republic of

Ulsan Univeristy Hospital; 🇰🇷 Ulsan, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of