Coronary Heart DiseasePhase 4NCT02044250

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

A Phase 4 study testing Clopidogrel and Aspirin in people with Coronary Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Coronary Heart Disease
What is being tested?: Clopidogrel and Aspirin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,530 participants
Where: 1 siteSouth Korea
Study dates: Feb 2014to Oct 2025
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 110-744

Other trials in South Korea

About this study

Official title: Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation

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

Read the detailed description

The primary purpose of this study is to compare the efficacy and safety of antiplatelet monotherapy with aspirin or clopidogrel for 2 years in patients who have not experienced MACE (major adverse cardiac events) including all-cause death, acute coronary syndrome including non-fatal MI (myocardial infarction), or urgent revascularization under combined antiplatelet therapy for 12 ± 6 months after PCI (percutaneous coronary intervention) with DES (drug-eluting stents). The trial tests the hypothesis that clopidogrel is superior to aspirin in preventing clinical events and device-oriented outcomes. Clinical events are defined as a composite of all-cause death, non-fatal MI, stroke, readmission due to acute coronary syndrome (ACS), or Bleeding Academic Research Consortium (BARC) class ≥ 3.29 Device-oriented outcomes include target lesion/vessel revascularization (TLR/TVR) and Academic Research Consortium (ARC)-defined stent thrombosis.

The primary endpoint of this study is the rate of clinical events defined as a composite of MACE and major bleeding complications. MACE includes all-cause death, non-fatal MI, stroke, and readmission due to ACS (acute coronary syndrome). Major bleeding is defined as bleeding (BARC class ≥ 3) at 24 months. Non-fatal MI is defined as any confirmed evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia without resulting in death, which is supported by electrocardiography, cardiac enzymes, or cardiac imaging according to the third Universal Definition of MI.37, 38 A readmission due to ACS is defined as any re-hospitalization definitely originating from an ACS event, which satisfies the definition of the American College of Cardiology Foundation and the American Heart Association.37, 39 A stroke is defined as any abrupt-onset, non-convulsive, focal, or global neurological deficit lasting more than 24 hours, which is caused by ischemia or hemorrhage in the brain.39 Secondary endpoints are the rate of device-oriented outcomes including TLR/TVR and stent thrombosis at 24 months, and minor gastrointestinal (GI) complications with the related cost-effectiveness. TLR is defined as any repeat revascularization procedure at the original lesion of the index procedure any time during the follow-up period.40 TVR is defined as any repeat revascularization procedure involving at least one of the target vessels that were treated in the index procedure.40 Stent thrombosis is defined according to the ARC.41, 42 Minor GI complications are assessed on the basis of newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy. At each visit, clinicians will question the patient regarding GI symptoms from intermittent epigastric soreness or bloating due to melena/hematochezia. Any additional GI medications, including H2-blockers and proton pump inhibitors, will be documented for each patient. If a patient undergoes endoscopy, the type of endoscopy, test results, and further interventions will be recorded. Additional medical costs related to these minor GI complications (South Korean won/year) will be calculated to assess the cost effectiveness of each drug based on average Korean expenses. All endpoints will be assessed primarily by the investigator and adjudicated secondarily by the independent clinical event committee.

Conditions: Coronary Heart Disease
Being tested: Clopidogrel, Aspirin
Keywords: Aspirin, Clopidogrel, Antiplatelet monotherapy, Drug-eluting stent
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ClopidogrelDrug
Also called Copregrel, Plateless, Cloart, Pidogul
Clopidogrel 75mg 1tab P.O. daily
AspirinDrug
Aspirin 100~200mg 1~2tab P.O. daily

Study groups in NCT02044250
Study group	Role	What they receive
Clopidogrel	Active comparator	Antiplatelet monotherapy : Clopidogrel 75mg P.O. daily Receives: Drug: Clopidogrel
Aspirin	Placebo comparator	Antiplatelet monotherapy : Aspirin 100~200mg P.O. daily Receives: Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 2 years

Secondary outcomes (3)

Target vessel revascularization (TVR), target lesion revascularization (TLR)
TVR, any repeat revascularization procedure involving at least one of the target vessels that were treated in the index procedure; TLR, any repeat revascularization procedure at the original lesion of the index procedure
Measured: 2 years
Stent thrombosis (acute, sub-acute, late, very late)
defined according to the ARC
Measured: 2 years
Minor gastrointestinal (GI) complications
newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Oct 2025

First posted23 Jan 2014 (estimated)
Study startFeb 2014
Primary completionMar 2021
Study completionOct 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5,530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02044250
Sponsor's protocol ID: HOST-EXAM Trial
Status last verified: Apr 2026
First submitted: 21 Jan 2014
Last updated: 27 Apr 2026
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 41921522
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. 2026 Jun;42(6):1129-1139. doi: 10.1016/j.cjca.2025.11.051. Epub 2025 Dec 24.
PubMed 41453443
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.
PubMed 40623657
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.
PubMed 39602157
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.
PubMed 37821166
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.
PubMed 37742741
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.
PubMed 37181388
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.
PubMed 37043192
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.
PubMed 37042284
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.
PubMed 36342475
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.
PubMed 34010616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation
ClinicalTrials.gov ID: NCT02044250
Acronym / sponsor ID: HOST-EXAM Trial
Conditions: Coronary Heart Disease
Keywords: Aspirin, Clopidogrel, Antiplatelet monotherapy, Drug-eluting stent
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,530 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Chong Kun Dang Pharmaceutical, Samjin Pharmaceutical Co., Ltd., Hanmi Pharmaceutical co., ltd., Daewoong Pharmaceutical Co. LTD.
Study start: Feb 2014 (actual)
Primary completion: Mar 2021 (actual)
Study completion: Oct 2025 (actual)
First posted: 23 Jan 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objectives :

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clopidogrel	Active comparator	Drug: ClopidogrelAntiplatelet monotherapy : Clopidogrel 75mg P.O. daily
Aspirin	Placebo comparator	Drug: AspirinAntiplatelet monotherapy : Aspirin 100~200mg P.O. daily

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ClopidogrelAlso: Copregrel, Plateless, Cloart, PidogulClopidogrel 75mg 1tab P.O. daily	Drug	Clopidogrel
AspirinAspirin 100~200mg 1~2tab P.O. daily	Drug	Aspirin

Primary outcome

Composite of major adverse cardiovascular events (MACE) and major bleeding complications
Time frame: 2 years
MACE, composite of all-cause death, non-fatal MI, stroke, and readmission due to ACS; major bleeding, bleeding of BARC class ≥3

3 secondary outcomes

Target vessel revascularization (TVR), target lesion revascularization (TLR)
Time frame: 2 years
Stent thrombosis (acute, sub-acute, late, very late)
Time frame: 2 years
Minor gastrointestinal (GI) complications
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Results publication: PubMed 41921522Kang 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.
Derived from this study: PubMed 41453443Song 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. 2026 Jun;42(6):1129-1139. doi: 10.1016/j.cjca.2025.11.051. Epub 2025 Dec 24.
Derived from this study: PubMed 40623657Han 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.
Derived from this study: PubMed 39602157Kang 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.
Derived from this study: PubMed 37821166Yang 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.
Derived from this study: PubMed 37742741Lee 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.
Derived from this study: PubMed 37181388Hwang 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.
Derived from this study: PubMed 37043192Rhee 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.
Derived from this study: PubMed 37042284Shin 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.
Derived from this study: PubMed 36342475Kang 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.
Derived from this study: PubMed 34010616Koo 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyo-Soo Kim, MD, PhD study chair

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel and Aspirin in people with Coronary Heart Disease, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite of major adverse cardiovascular events (MACE) and major bleeding complications (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02044250, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.