drugset / Trial / NCT02044250
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)
Phase 4
Completed
5530 enrolled
Seoul National University Hospital
Chong Kun Dang Pharmaceutical · collabDaewoong Pharmaceutical Co. LTD. · collabHanmi Pharmaceutical Company Limited · collabSamjin Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2014-02
- Primary completion
- 2021-03
- Completion
- 2025-10
Publications
- Results Kang J, Park S, Yang HM, Shin ES, Rha SW, Bae JW, Lee NH, Yoon HJ, Cho YH, Kim U, Kim SY, Kim SH, Han JK, Park KW, Kim HS; HOST-EXAM investigators. Aspirin versus clopidogrel for chronic maintenance monotherapy after percutaneous coronary intervention: 10-year follow-up of the HOST-EXAM trial. Lancet. 2026 Apr 11;407(10537):1439-1447. doi: 10.1016/S0140-6736(26)00422-8. Epub 2026 Mar 29.
- Song JE, Yang HM, Kang J, Hwang D, Han JK, Park KW, Kang HJ, Koo BK, Kim HS. 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. 2025 Dec 24:S0828-282X(25)01576-4. doi: 10.1016/j.cjca.2025.11.051. Online ahead of print.
- Han M, Kang J, Kim B, Hwang D, Yang HM, Park KW, Won KB, Han JK, Koo BK, Shin ES, Kim HS. The impact of body mass index on antiplatelet monotherapy strategy for secondary prevention after percutaneous coronary intervention: A substudy of the HOST-EXAM trial. Am Heart J. 2025 Dec;290:258-267. doi: 10.1016/j.ahj.2025.07.005. Epub 2025 Jul 5.
- Kang J, Chung J, Park KW, Bae JW, Lee H, Hwang D, Yang HM, Han KR, Moon KW, Kim U, Rhee MY, Kim DI, Kim SY, Lee SY, Lee SU, Kim SW, Kim SY, Han JK, Shin ES, Koo BK, Kim HS. Long-Term Aspirin vs Clopidogrel After Coronary Stenting by Bleeding Risk and Procedural Complexity. JAMA Cardiol. 2025 May 1;10(5):427-436. doi: 10.1001/jamacardio.2024.4030.
- Yang S, Kang J, Park KW, Hur SH, Lee NH, Hwang D, Yang HM, Ahn HS, Cha KS, Jo SH, Ryu JK, Suh IW, Choi HH, Woo SI, Han JK, Shin ES, Koo BK, Kim HS. Comparison of Antiplatelet Monotherapies After Percutaneous Coronary Intervention According to Clinical, Ischemic, and Bleeding Risks. J Am Coll Cardiol. 2023 Oct 17;82(16):1565-1578. doi: 10.1016/j.jacc.2023.07.031.
- Lee K, Kang J, Park KW, Park TH, Kim BS, Lim SW, Cho YH, Jeon DW, Kim SH, Yang HM, Kang HJ, Han JK, Shin ES, Koo BK, Kim HS. Impact of Age on Antiplatelet Monotherapy in the Chronic Maintenance Period After Percutaneous Coronary Intervention: A Post Hoc Analysis From the HOST-EXAM Extended Study. Can J Cardiol. 2024 Jan;40(1):43-52. doi: 10.1016/j.cjca.2023.09.021. Epub 2023 Sep 22.
- Hwang D, Kim HL, Koo BK, Rhee TM, Yang DW, Seo Y, Byun J, Kang J, Han JK, Park KW, Shin ES, Rha SW, Bae JW, Mamas MA, Cohen DJ, Lee TJ, Kim HS; HOST-EXAM Investigators. Cost-Effectiveness of Clopidogrel vs Aspirin Monotherapy After Percutaneous Coronary Intervention: Results From the HOST-EXAM Study. JACC Asia. 2023 Mar 14;3(2):198-207. doi: 10.1016/j.jacasi.2022.12.007. eCollection 2023 Apr.
- Rhee TM, Bae JW, Park KW, Rha SW, Kang J, Lee H, Yang HM, Kwak SH, Chae IH, Shin WY, Kim DK, Oh JH, Jeong MH, Kim YH, Lee NH, Hur SH, Yoon J, Han JK, Shin ES, Koo BK, Kim HS; HOST-EXAM Investigators. Aspirin vs Clopidogrel for Long-term Maintenance After Coronary Stenting in Patients With Diabetes: A Post Hoc Analysis of the HOST-EXAM Trial. JAMA Cardiol. 2023 Jun 1;8(6):535-544. doi: 10.1001/jamacardio.2023.0592.
- Shin ES, Jun EJ, Kim B, Won KB, Koo BK, Kang J, Park KW, Rhee TM, Yang HM, Han JK, Kim HS; HOST-EXAM Investigators. Association of Clinical Outcomes With Sex in Patients Receiving Chronic Maintenance Antiplatelet Monotherapy After Percutaneous Coronary Intervention: A Post Hoc Gender Analysis of the HOST-EXAM Study. J Am Heart Assoc. 2023 Apr 18;12(8):e026770. doi: 10.1161/JAHA.122.026770. Epub 2023 Apr 12.
- Kang J, Park KW, Lee H, Hwang D, Yang HM, Rha SW, Bae JW, Lee NH, Hur SH, Han JK, Shin ES, Koo BK, Kim HS. Aspirin Versus Clopidogrel for Long-Term Maintenance Monotherapy After Percutaneous Coronary Intervention: The HOST-EXAM Extended Study. Circulation. 2023 Jan 10;147(2):108-117. doi: 10.1161/CIRCULATIONAHA.122.062770. Epub 2022 Nov 7.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 100 mg | Oral |
| Comparator | Aspirin | Small molecule | 200 mg | Oral |
| Comparator | Clopidogrel | Small molecule | 75 mg | Oral |