Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Mon… (NCT02044250) | Clinical Trial Compass
CompletedPhase 4
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)
South Korea5,530 participantsStarted 2014-02
Plain-language summary
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
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
Composite of major adverse cardiovascular events (MACE) and major bleeding complications