NCT03757156

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,118 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants With Moderate and High Cardiovascular Risk

Interventions

Type	Name	Description
OTHER	Withdrawal of aspirin	People who are taking aspirin stop to taking aspirin.

Timeline

• Start date: 2019-03-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2018-11-28
• Last updated: 2019-02-11

Locations

1 site across 1 country: South Korea