Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial (HOST-IDEA)

January 8, 2023 updated by: Hyo-Soo Kim, Seoul National University Hospital

We had little experience in coronary intervention with recently introduced newer drug-eluting stent (DES) platforms, despite great anticipation, and optimal duration of dual antiplatelet therapy (DAPT) for these stent systems still needs to be established.

Herein, we plan the HOST-coronary intervention with next-generation drug-eluting stent platforms and abbreviated dual antiplatelet therapy (HOST-IDEA) trial to compare single antiplatelet therapy (SAPT) after 3-month DAPT with 12-month DAPT in all-comers undergoing coronary intervention with third-generation DES with the thinnest struts.

P2Y12 inhibitor treatment is added to aspirin during the 3-months period after the stenting, and this abbreviated duration of DAPT will be compared with conventional 1-year mandatory DAPT regimen in a 1:1 randomized stratification.

Net adverse clinical events (NACEs), a composite of cardiac death, target vessel related myocardial infarction, clinically-drivent target lesion revascularization, definite or probable stent thrombosis and major bleeding is a primary endpoint for evaluating safety and efficacy of the difference of DAPT duration.

1-year target lesion failure (TLF) as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target lesion revascularization will be identified as a secondary ischemic outcome. 1-year major bleeding events classified as BARC type 3 or 5 bleeding events will be identified as a secondary bleeding outcome.

With this trial, you will be able to get clear insight on the behavior of newer DES platforms. Reference data for the shortened mandatory DAPT regimen will also be delineated in the selected patients, and it might be helpful to those who need it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Every antiplatelet-naïve patient undergoing an elective procedure will be given 300 mg aspirin and loading dose of one of P2Y12 receptor inhibitors (e.g., 600 mg clopidogrel, 60 mg prasugrel or 180 mg ticagrelor) preferably ≥2 hours before the intervention. These loading doses can be waived for chronic antiplatelet users, and prasugrel or ticagrelor can be used instead of clopidogrel. Choice for P2Y12 inhibitors will be left to responsible physicians' discretion, and this decision will be based on the patient/lesional characteristics.

Study Type

Interventional

Enrollment (Actual)

2173

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 Contact

  • Name: Hyo-Soo Kim, M.D., Ph.D.
  • Phone Number: 82-2-2072-2226
  • Email: hyosoo@snu.ac.kr

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Kosin University Gospel Hospital
      • Busan, Korea, Republic of
        • Busan Paik Hospital
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Cheonan Hospital
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Gwangju, Korea, Republic of
        • Gwangju Christian Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Hallym University Kangdong Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong
      • Seoul, Korea, Republic of
        • Korea University Guro Hospital
      • Seoul, Korea, Republic of
        • Ewha Womans University Medical Center Mokdong Hospital
      • Seoul, Korea, Republic of
        • KangNam Sacred Heart Hospital
      • Suwon, Korea, Republic of
        • Ajou 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with de novo stenotic lesions who are suitable for coronary stenting with drug-eluting stent

Exclusion Criteria:

  • 1. High risk profiles for ischemic adverse events such as A. ST-segment elevation myocardial infarction (STEMI) B. Patients with cardiogenic shock or concomitant severe decompensated heart failure C. Myocardial infarction or stent thrombosis in spite of the maintenance of antiplatelet therapy D. Restenosis in stented segments or previous sites of balloon angioplasty 2. Patients who cannot follow allocated DAPT schedule due to the planned surgery or elective procedure within 3 months after the stenting 3. Recent history of major surgery or evident events of gastrointestinal bleeding within 1 month from the procedure 4. Patients on anticoagulation therapy with warfarin or other anticoagulants 5. Life expectancy less than 1 year (such as malignancies or other chronic systemic diseases) 6. Pregnant women 7. Past history of allergy or other contraindications for the following medications/materials: aspirin, clopidogrel, heparin, cobalt chromium, sirolimus

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
Experimental: Orsiro SES or CX-ISAR/3-months DAPT
Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Corflex ISAR stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.
Drug: 3-months DAPT
Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting
Other Names:
  • Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting
Active Comparator: Orsiro SES or CX-ISAR/1-year DAPT
Patients allocated to this group will be implanted with Orisro sirolimus-eluting stents or Coroflex ISAR stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.
Drug: 1-year DAPT
Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting
Other Names:
  • Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NACEs (net adverse clinical events)
Time Frame: post-stenting 12 months
a composite of cardiac death, target vessel-related non-fatal myocardial infarction, clinically-driven target lesion revascularization, definite or probable stent thrombosis, and major bleeding
post-stenting 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TLF (target lesion failure)
Time Frame: post-stenting 12 months
a composite of cardiac death, target vessel-related non-fatal myocardial infarction, and clinically-driven target lesion revascularization
post-stenting 12 months
Major bleeding
Time Frame: post-stenting 12 months
Major bleeding events classified as BARC type 3 or 5 bleeding events
post-stenting 12 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Collaborators

B. Braun Korea Co., Ltd.

Investigators

  • Study Chair: Hyo-Soo Kim, M.D., Ph.D., Seoul National University Hospital

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

January 18, 2016

Primary Completion (Actual)

August 14, 2021

Study Completion (Actual)

August 14, 2022

Study Registration Dates

First Submitted

November 7, 2015

First Submitted That Met QC Criteria

November 7, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HOST-IDEA 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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