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

April 10, 2021 updated by: Hyo-Soo Kim, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5530

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Clopidogrel
Antiplatelet monotherapy : Clopidogrel 75mg P.O. daily
Drug: Clopidogrel
Clopidogrel 75mg 1tab P.O. daily
Other Names:
  • Copregrel, Plateless, Cloart, Pidogul
Placebo Comparator: Aspirin
Antiplatelet monotherapy : Aspirin 100~200mg P.O. daily
Drug: Aspirin
Aspirin 100~200mg 1~2tab P.O. daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel revascularization (TVR), target lesion revascularization (TLR)
Time Frame: 2 years
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
2 years
Stent thrombosis (acute, sub-acute, late, very late)
Time Frame: 2 years
defined according to the ARC
2 years
Minor gastrointestinal (GI) complications
Time Frame: 2 years
newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Chong Kun Dang Pharmaceutical
Daewoong Pharmaceutical Co. LTD.
Hanmi Pharmaceutical co., ltd.
Samjin Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 22, 2014

First Posted (Estimate)

January 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 14, 2021

Last Update Submitted That Met QC Criteria

April 10, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOST-EXAM Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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