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.
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 Type
OBSERVATIONAL
Enrollment
5,530
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
Patient oriented composite outcome
A composite of all-cause death, nonfatal myocardial infarction, stroke, readmission due to acute coronary syndrome, and major bleeding complication
Time frame: From date of randomization until March, 2022.
Thrombotic outcome
cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis
Time frame: From date of randomization until March, 2022.
Bleeding outcome
Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
Time frame: From date of randomization until March, 2022.
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