Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation (HOST-EXAM-EX)

Seoul National University

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Atheroscleroses, Coronary

Treatments: Drug: Antiplatelet Agents

Study type: Observational

Funder types: Other

Identifiers

NCT05567536

1208-028-421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,530 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,530 participants in 2 patient groups

Clopidogrel group

Description:

This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.

Treatment:

Drug: Antiplatelet Agents

Aspirin group

Description:

This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.

Treatment:

Drug: Antiplatelet Agents