NCT05567536

Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation

HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,530 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

Summary

This is an retrospective extended study of a randomized clinical trial (The HOST-EXAM trial ClinicalTrials.gov Identifier: NCT02044250). Investigators will perform a retrospective analysis of all participants enrolled in this trial will be performed, until the longest follow-up duration.

Detailed description

The HOST-EXAM trial (ClinicalTrials.gov Identifier: NCT02044250) was an randomized clinical trial that was performed to compare head-to-head, the efficacy and safety between aspirin and clopidogrel monotherapy in patients who received PCI for coronary artery disease and required chronic maintenance antiplatelet therapy. From March 2014 through May 2018, a total of 5438 patients were enrolled, and follow-up was performed upto 24 months after randomization. After this study, randomization was unlocked and patients were followed-up based on the standard protocol. Afterwards, the current study was planned to perform a extended follow-up of the HOST-EXAM population. The specific drug by the randomization group in the HOST-EXAM trial was not mandatory after the initial 24 months, therefore participants received medication according to the current guidelines, and according to the physicians preferences. This is a observational, retrospective analysis of all clinical events after the randomization period. The prescribed medications and any clinical events will be evaluated.

Conditions

• Coronary Artery Disease
• Atheroscleroses, Coronary

Interventions

Type	Name	Description
DRUG	Antiplatelet Agents	Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent

Timeline

• Start date: 2014-03-01
• Primary completion: 2022-10-01
• Completion: 2028-12-31
• First posted: 2022-10-05
• Last updated: 2022-10-05

Regulatory

• FDA-regulated drug study