Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease

Study Overview
=================
Brief Summary
-----------------
While the efficacy of aspirin for the secondary prevention of cardiovascular disease is evident, the effect of aspirin for primary prevention is unclear. The use of aspirin reduces cardiovascular mortality and myocardial infarction but increases side effects such as bleeding. Therefore, the use of aspirin for primary prevention in people without cardiovascular disease should be determined by individual risk and clinical benefit. The European guidelines have been changed to not recommend aspirin use in people without cardiovascular disease, but there are still people taking aspirin for primary prevention. The purpose of this study is to investigate the effect of aspirin withdrawal on cardiovascular events in patients without cardiovascular disease. This is a single center, prospective, randomized clinical study evaluating the safety and efficacy of withdrawal of aspirin among patients with moderate or high cardiovascular risk.

Detailed Description
-----------------
Patients taking aspirin will be randomly assigned to a group that maintains taking aspirin and a group that discontinues to take aspirin by 1:1 manner. The follow-up duration is five years and clinical outcomes will be investigated.

Official Title
-----------------
Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease

Conditions
-----------------
Healthy Participants With Moderate and High Cardiovascular Risk

Intervention / Treatment
-----------------
* Other: Withdrawal of aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 19-80 years old Subjects who are taking for more than 12 months Subjects with moderate or high cardiovascular risk based on cardiovascular risk classification of 2015 Korea Society of Lipidology And Atherosclerosis guideline or 2004 American Heart Association guideline: 1) moderate risk: people with ≥2 major risk factors, 2) high risk: people with carotid atherosclerosis, abdominal aortic aneurysm, or diabetes, who is taking statin Subjects who voluntarily participate in the study and sign informed consent form Exclusion Criteria: Subjects with a history of major cardiovascular disease confirmed by medical history and medical history; myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass surgery, peripheral vascular disease, ischemic stroke, transient ischemic attack Subjects has any contraindication to use of aspirin or hypersensitivity to aspirin Subjects with atrial fibrillation Subjects who are taking anti-platelet agents other than aspirin or anticoagulants Subjects who have been diagnosed with cancer within the last 5 years Pregnant women or those who have pregnancy plan after enrolling in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aspirin maintenance group versus aspirin interruption group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Aspirin maintenance group<br>People who are taking aspirin continue to take aspirin. | |
| Experimental: Aspirin withdrawal group<br>People who are taking aspirin stop to taking aspirin. | Other: Withdrawal of aspirin<br>* People who are taking aspirin stop to taking aspirin.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events(MACE) | Major adverse cardiovascular events is composite endpoint. It includes cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft), nonfatal ischemic stroke, and transient ischemic attack. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular death | Individual component of primary endpoint | 5 years | 
| nonfatal myocardial infarction | Individual component of primary endpoint | 5 years | 
| nonfatal ischemic stroke | Individual component of primary endpoint | 5 years | 
| coronary revascularization | Individual component of primary endpoint | 5 years | 
| transient ischemic attack | Individual component of primary endpoint | 5 years | 
| Bleeding | Major bleeding is defined with International Society on Thrombosis and Haemostasis (ISTH) criteria: 1) fatal bleeding; 2)Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; 3) bleeding causing a fall in hemoglobin level of 2 g/dL or more, or leading to transfuction of two or more units of whole blood or red cells. Bleeding that is not classified as major bleeding is minor. | 5 years |