Healthy Participants With Moderate and High Cardiovascular Risk Clinical Trial
Official title:
Aspirin Withdrawal and Clinical Outcome in Patients With Moderate to High Cardiovascular Risk But Without Cardiovascular Disease
| Verified date | February 2019 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Not yet recruiting |
| Enrollment | 4118 |
| Est. completion date | November 2024 |
| Est. primary completion date | November 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Division of Cardiology, Cardiovascular Center, Severance Hospital, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | cardiovascular death | Individual component of primary endpoint | 5 years | |
| Secondary | nonfatal myocardial infarction | Individual component of primary endpoint | 5 years | |
| Secondary | nonfatal ischemic stroke | Individual component of primary endpoint | 5 years | |
| Secondary | coronary revascularization | Individual component of primary endpoint | 5 years | |
| Secondary | transient ischemic attack | Individual component of primary endpoint | 5 years | |
| Secondary | 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 |