Coronary Artery Disease, Atheroscleroses, Coronary
Conditions
Keywords
percutenous coronary intervention, drug-eluting stent, chronic maintenance period
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.
Interventions
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Bleeding outcome | From date of randomization until March, 2022. | Bleeding Academic Research Consortium (BARC) type ≥2 bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | From date of randomization until March, 2022. | Death from any cause |
| Cardiac death | From date of randomization until March, 2022. | Death from a cardiac cause |
Outcome results
None listed