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

NCT02044250 | Completed Phase 4 DMC

• 1 other identifier: HOST-EXAM Trial
• Study Type: interventional
• Target: 5,530
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Coronary Heart Disease

Keywords

Aspirin; Clopidogrel; Antiplatelet monotherapy; Drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• Composite of major adverse cardiovascular events (MACE) and major bleeding complications

  MACE, composite of all-cause death, non-fatal MI, stroke, and readmission due to ACS; major bleeding, bleeding of BARC class ≥3

  2 years

Secondary Outcomes (3)

• Target vessel revascularization (TVR), target lesion revascularization (TLR)

  2 years

• Stent thrombosis (acute, sub-acute, late, very late)

  2 years

• Minor gastrointestinal (GI) complications

  2 years

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Antiplatelet monotherapy : Clopidogrel 75mg P.O. daily

Drug: Clopidogrel

Aspirin

PLACEBO COMPARATOR

Antiplatelet monotherapy : Aspirin 100\~200mg P.O. daily

Drug: Aspirin

Interventions

Clopidogrel DRUG

Clopidogrel 75mg 1tab P.O. daily

Also known as: Copregrel, Plateless, Cloart, Pidogul

Clopidogrel

Aspirin DRUG

Aspirin 100\~200mg 1\~2tab P.O. daily

Aspirin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known coagulopathy or refusal of blood transfusion
• Presence of non-cardiac comorbidity with life expectancy \<2 years from randomization
• Plan to surgery or intervention which needs to stop antiplatelet agents ≥3 months
• Females with childbearing potential or breast-feeding
• Conditions that may result in protocol non-compliance by the committees
• 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
• Refusal to give written informed consent

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Chong Kun Dang Pharmaceutical: collaborator
• Samjin Pharmaceutical Co., Ltd.: collaborator
• Daewoong Pharmaceutical Co. LTD.: collaborator
• Hanmi Pharmaceutical co., ltd.: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (11)

• 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 Mar 29:S0140-6736(26)00422-8. doi: 10.1016/S0140-6736(26)00422-8. Online ahead of print.

  PMID: 41921522 RESULT

• 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.

  PMID: 41453443 DERIVED

• 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.

  PMID: 40623657 DERIVED

• 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.

  PMID: 39602157 DERIVED

• 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.

  PMID: 37821166 DERIVED

• 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.

  PMID: 37742741 DERIVED

• 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.

  PMID: 37181388 DERIVED

• 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.

  PMID: 37043192 DERIVED

• 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.

  PMID: 37042284 DERIVED

• 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.

  PMID: 36342475 DERIVED

• 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.

  PMID: 34010616 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Hyo-Soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: October 1, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (1)