Long Term Follow-up of Comparison of Clopidogrel vs. Aspirin Monotherapy After Drug-eluting Stent Implantation (HOST-EXAM-EX)
HOST-EXAM-Ex : Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - EXtended Antiplatelet Monotherapy - EXtended Follow up
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients who were enrolled in the HOST-EXAM randomized clinical trial will be analyzed for an extended follow-up duration.
Patients enrolled in the HOST-EXAM trial were patients that received stenting with a drug-eluting stent and had successfully completed 6-18 months of DAPT without events.
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Clopidogrel group
This group are those who received clopidogrel 75mg qd as a single antiplatelet agent therapy after PCI.
|
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
|
|
Aspirin group
This group are those who received aspirin 100mg qd as a single antiplatelet agent therapy after PCI.
|
Patients who received a single antiplatelet agent will be analyzed according to the prescribed antiplatelet agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient oriented composite outcome
Time Frame: 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
|
From date of randomization until March, 2022.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thrombotic outcome
Time Frame: From date of randomization until March, 2022.
|
cardiac death, non-fatal MI, ischemic stroke, readmission due to ACS, and definite or probable stent thrombosis
|
From date of randomization until March, 2022.
|
|
Bleeding outcome
Time Frame: From date of randomization until March, 2022.
|
Bleeding Academic Research Consortium (BARC) type ≥2 bleeding
|
From date of randomization until March, 2022.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause death
Time Frame: From date of randomization until March, 2022.
|
Death from any cause
|
From date of randomization until March, 2022.
|
|
Cardiac death
Time Frame: From date of randomization until March, 2022.
|
Death from a cardiac cause
|
From date of randomization until March, 2022.
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Antithrombotic Trialists' (ATT) Collaboration, Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Buring J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaglioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet. 2009 May 30;373(9678):1849-60. doi: 10.1016/S0140-6736(09)60503-1.
- Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Won KB, Rha SW, Bae JW, Lee NH, Hur SH, Yoon J, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Han JK, Shin ES, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention (HOST-EXAM): an investigator-initiated, prospective, randomised, open-label, multicentre trial. Lancet. 2021 Jun 26;397(10293):2487-2496. doi: 10.1016/S0140-6736(21)01063-1. Epub 2021 May 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1208-028-421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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