Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)

• Status: Completed
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Chong Kun Dang Pharmaceutical; Daewoong Pharmaceutical Co. LTD.; HANMI PHARMA CO.,Ltd; Hanmi Pharmaceutical co., ltd.; Samjin Pharmaceutical Co., Ltd.
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

1. Male and female aged ≥20 years

2. Maintenance of dual or triple antiplatelet therapy at least 12 ± 6 months after PCI with DES

3. No history of further clinical event after PCI with DES

4. Plan to change to antiplatelet monotherapy

5. Agreement to give written informed consent

Exclusion Criteria:

1. History of hypersensitivity to aspirin or clopidogrel

2. History of contraindication to aspirin or clopidogrel

3. Active pathologic bleeding, such as peptic ulcer, tumor bleeding or intracranial hemorrhage

4. History of major bleeding, BARC class ≥3, resulting in stop of antiplatelet agents within 3 months

5. Bleeding diathesis

6. Known coagulopathy or refusal of blood transfusion

7. Presence of non-cardiac comorbidity with life expectancy <2 years from randomization

8. Plan to surgery or intervention which needs to stop antiplatelet agents ≥3 months

9. Females with childbearing potential or breast-feeding

10. Conditions that may result in protocol non-compliance by the committees

11. 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

12. Refusal to give written informed consent