Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03718559
Other study ID # AMCCVEP2018-01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 14, 2019
Est. completion date November 8, 2023

Study information

Verified date June 2024
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1040
Est. completion date November 8, 2023
Est. primary completion date November 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria 1. A subject was = 18 years of age 2. Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score =2) 3. Patients with Stable coronary artery disease - Anatomically confirmed coronary artery disease (with =50% stenosis of major epicardial coronary artery documented by cardiac catheterization or coronary computed tomographic angiography) on medical therapy alone. - Revascularized coronary artery disease (either Percutaneous Coronary Intervention or coronary bypass surgery) whom the last revascularization should be performed =12 months before study enrollment for the acute coronary syndrome and =6 months for stable angina pectoris. Exclusion Criteria 1. Patients with thrombocytopenia 2. High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time) 3. Prior history of intracranial haemorrhage 4. Mechanical prosthetic valve or moderate to severe mitral stenosis 5. The risk of bleeding increased due to the following reasons; - i. history of gastrointestinal ulcers within 1 month - ii. Malignant tumor with high risk of bleeding - iii. Brain or spinal cord injury within 1 month - iv. History of intracranial or intracerebral hemorrhage within 12 months - v. Esophageal varices - vi. Spinal cord vascular abnormalities or intracerebral vascular abnormalities - vii. Active bleeding - viii. Hemoglobin level <7.0 g/dL or platelet count = 50,000 / mm3 - ix. History of major surgery within 1 month 6. Uncontrolled severe hypertension 7. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy 8. History of hypersensitivity to Edoxaban, aspirin, or clopidogrel 9. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption 10. Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization 11. Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality) 12. Estimated CrCl by Cockcroft-Gault equation<15 mL/min 13. Life expectancy less than 12 months 14. The subject was unable to provide written informed consent or participate in long-term follow-up 15. Pregnant and/or lactating women 16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Study Design


Intervention

Drug:
Edoxaban Monotherapy
Taking edoxaban (Lixiana™, Daiichi-Sankyo Inc.) 60mg once daily. The dose of edoxaban will be reduced to 30mg once daily in patients with estimated creatinine clearance 15=CrCL=50mL/min by Cockcroft-Gault equation or weight is =60kg.
Edoxaban plus Single Antiplatelet Agent
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.

Locations

Country Name City State
Korea, Republic of Hallym University Medical Center Anyang
Korea, Republic of Soon Chun Hyang University Hospital Bucheon Bucheon
Korea, Republic of Keimyung University Dongsan Medical Center Daegu
Korea, Republic of Dongguk University Ilsan Hospital Ilsan
Korea, Republic of Dong-A University Hospital Pusan
Korea, Republic of Inje University Haeundae Paik Hospital Pusan
Korea, Republic of Seoul National University Bundang Hospital Seongnam
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Kangdong KyungHee University hospital Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of The Catholic Univ. of Korea, Seoul St. Mary's Hospital Seoul
Korea, Republic of The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital Seoul
Korea, Republic of VHS medical center Seoul
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon
Korea, Republic of Ulsan Univeristy Hospital Ulsan
Korea, Republic of Pusan National University Yangsan Hospital Yangsan

Sponsors (2)

Lead Sponsor Collaborator
Gi-Byoung Nam CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of net Clinical Outcome 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 1 year
Secondary Rate of all cause death 1 year
Secondary Rate of cardiovascular death 1 year
Secondary Rate of myocardial infarction 1 year
Secondary Rate of ischemic stroke 1 year
Secondary Rate of systemic embolism 1 year
Secondary Rate of unplanned revascularization 1 year
Secondary Rate of composite of hard outcomes all cause death, myocardial infarction, ischemic stroke, and systemic embolism 1 year
Secondary Rate of stent thrombosis 1 year
Secondary Rate of composite of Major or clinically relevant non-major bleeding 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.
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.
1 year
Secondary Rate of fatal bleeding International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5 1 year
Secondary Rate of major bleeding ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding 1 year
Secondary Rate of minor bleeding ISTH, BARC and TIMI criteria 1 year
Secondary Rate of intracranial hemorrhage 1 year
Secondary Rate of gastrointestinal hemorrhage 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A