NCT02044250CompletedPhase 4
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)
Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
Objectives : To compare the efficacy and safety of clopidogrel monotherapy with aspirin monotherapy in patients who received dual or triple antiplatelet therapy for 1 year (± 6 months) after drug-eluting stent implantation for coronary artery disease Patient Enrollment : 5530 patients enrolled at 55 centers in Korea Patient Follow-up : Clinical follow-up will occur at 1, 12 and 24 months. Primary Endpoint : Composite endpoint of MACE and major bleeding Secondary Endpoint : Device-oriented composite outcome including TLR (target lesion revascularization), TVR (target vessel revascularization), stent thrombosis, and minor GI (gastrointestinal) complications
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 5530 (actual)
- First submitted
- 21 Jan 2014
- Start date
- Feb 2014
- Primary completion date
- Mar 2021
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT02044250
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 5530
- From Feb 2014 to the primary completion date, Mar 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Plan to surgery or intervention which needs to stop antiplatelet agents ≥3 months
- Co-administration of contraindicated medications as follows: other P2Y 12 inhibitors (prasugrel or ticagrelor); anticoagulants (warfarin, new oral anticoagulants, or chronic therapy of heparin); cytochrome P450 2C19 inhibitors (fluoxetine, moclobemid or voriconazole); probenecid; high dose of methotrexate (≥15 mg/week); lithium
Other illness
- History of hypersensitivity to aspirin or clopidogrel
- History of contraindication to aspirin or clopidogrel
- Active pathologic bleeding, such as peptic ulcer, tumor bleeding or intracranial hemorrhage
- History of major bleeding, BARC class ≥3, resulting in stop of antiplatelet agents within 3 months
- Bleeding diathesis
- Presence of non-cardiac comorbidity with life expectancy \<2 years from randomization
- Conditions that may result in protocol non-compliance by the committees
Other
- Known coagulopathy or refusal of blood transfusion
- Females with childbearing potential or breast-feeding
- Refusal to give written informed consent
Who the study is looking for
- Male and female aged ≥20 years
- Maintenance of dual or triple antiplatelet therapy at least 12 ± 6 months after PCI with DES
- No history of further clinical event after PCI with DES
- Plan to change to antiplatelet monotherapy
- Agreement to give written informed consent
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
Related publications
- Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial.Lancet · 2026 · PMID 41921522
- Long-term Clopidogrel vs Aspirin Monotherapy in Coronary Artery Disease Patients With High Ischemic Risk: HOST-EXAM Extended Study Post hoc Analysis.Can J Cardiol · 2026 · PMID 41453443
This page is information, not medical advice. Discuss any trial with your doctor.