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

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ClinicalTrials.gov Identifier: NCT02044250
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : April 14, 2021
Sponsor:
Collaborators:
Chong Kun Dang Pharmaceutical
Samjin Pharmaceutical Co., Ltd.
Daewoong Pharmaceutical Co. LTD.
Hanmi Pharmaceutical co., ltd.
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date April 14, 2021
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
Composite of adverse cardiovascular outcomes [ Time Frame: 2 years ]
composite of cardiovasculr death, myocardial infarction, stroke, severe/moderate bleeding, readmission due to acute coronary syndrome, urgent revascularization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
  • 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
  • Stent thrombosis (acute, sub-acute, late, very late) [ Time Frame: 2 years ]
    defined according to the ARC
  • Minor gastrointestinal (GI) complications [ Time Frame: 2 years ]
    newly developed GI symptoms, newly added GI medications, or symptom-driven GI endoscopy
Original Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2014)
  • Target vessel/lesion revascularization [ Time Frame: 2 years ]
  • Stent thrombosis (acute, sub-acute, late, very late) [ Time Frame: 2 years ]
  • Peripheral vascular intervention [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)
Official Title  ICMJE Comparison of Clopidogrel vs. Aspirin Monotherapy Beyond Two Year After Drug-eluting Stent Implantation
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

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • Drug: Clopidogrel
    Clopidogrel 75mg 1tab P.O. daily
    Other Name: Copregrel, Plateless, Cloart, Pidogul
  • Drug: Aspirin
    Aspirin 100~200mg 1~2tab P.O. daily
Study Arms  ICMJE
  • Active Comparator: Clopidogrel
    Antiplatelet monotherapy : Clopidogrel 75mg P.O. daily
    Intervention: Drug: Clopidogrel
  • Placebo Comparator: Aspirin
    Antiplatelet monotherapy : Aspirin 100~200mg P.O. daily
    Intervention: Drug: Aspirin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2016)
5530
Original Estimated Enrollment  ICMJE
 (submitted: January 22, 2014)
5500
Actual Study Completion Date  ICMJE March 2021
Actual Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02044250
Other Study ID Numbers  ICMJE HOST-EXAM Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyo-Soo Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Chong Kun Dang Pharmaceutical
  • Samjin Pharmaceutical Co., Ltd.
  • Daewoong Pharmaceutical Co. LTD.
  • Hanmi Pharmaceutical co., ltd.
Investigators  ICMJE
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP