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

Active, not recruiting

• Conditions: Atheroscleroses, Coronary; Coronary Artery Disease
• Interventions: Drug: Antiplatelet Agents

• Registration Number: NCT05567536
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2022-09-26
• Status Verified: 2022-10
• Primary Completion: 2022-10-01
• Study First Submitted QC: 2022-10-01
• Last Update Submitted: 2022-10-01
• Study First Posted: 2022-10-05
• Last Update Posted: 2022-10-05
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5530

Inclusion Criteria

• Patients who were enrolled in the HOST-EXAM randomized clinical trial

Exclusion Criteria

• None, otherwise the patient refuses to participate in this study, or refuses to provide personal medical information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clopidogrel group	Antiplatelet Agents	This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.
Aspirin group	Antiplatelet Agents	This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.

Primary Outcome Measures

Name	Time	Method
Patient oriented composite outcome	From date of randomization until March, 2022.	A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication

Secondary Outcome Measures

Name	Time	Method
Bleeding outcome	From date of randomization until March, 2022.	Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
Thrombotic outcome	From date of randomization until March, 2022.	cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis