AzTrials
AzTrials

Stable AnginaPhase 4HOST-IDEANCT02601157

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

A Phase 4 study testing 3-months DAPT and 1-year DAPT in people with Stable Angina and Unstable Angina, run by Seoul National University Hospital at 12 sites 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

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. Read more about this study

Who is it for?
Any age
What is being tested?
3-months DAPT and 1-year DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,173 participants
Where
12 sitesSouth Korea
Study dates
18 Jan 2016to 14 Aug 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Busan Paik Hospital

    Busan

  • Kosin University Gospel Hospital

    Busan

  • SoonChunHyang University Cheonan Hospital

    Cheonan

  • Chonnam National University Hospital

    Gwangju

  • Gwangju Christian Hospital

    Gwangju

  • Ewha Womans University Medical Center Mokdong Hospital

    Seoul

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul

  • Kangnam Sacred Heart Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital at Gangdong

    Seoul

  • Seoul National University Hospital

    Seoul

  • Ajou University Hospital

    Suwon

Other trials in South Korea

About this study

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.

Read more

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.

Read the 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.

Being tested
3-months DAPT, 1-year DAPT
Keywords
stent, polymer, antiplatelet therapy, clopidogrel
Medical subject headings
Angina, Stable, Angina, Unstable

What participants receive

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

  • 3-months DAPTDrug

    Also called Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting

    Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting

  • 1-year DAPTDrug

    Also called Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting

    Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting

Study groups in NCT02601157
Study groupRoleWhat they receive
Orsiro SES or CX-ISAR/3-months DAPTExperimentalPatients 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.
Receives: Drug: 3-months DAPT
Orsiro SES or CX-ISAR/1-year DAPTActive comparatorPatients 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.
Receives: Drug: 1-year DAPT

What is being measured

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

  1. NACEs (net adverse clinical events)

    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

    Measured: post-stenting 12 months

Secondary outcomes (2)

  1. TLF (target lesion failure)

    a composite of cardiac death, target vessel-related non-fatal myocardial infarction, and clinically-driven target lesion revascularization

    Measured: post-stenting 12 months

  2. Major bleeding

    Major bleeding events classified as BARC type 3 or 5 bleeding events

    Measured: post-stenting 12 months

Timeline

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

  1. First posted10 Nov 2015 (estimated)
  2. Study start18 Jan 2016
  3. Primary completion14 Aug 2021
  4. Study completion14 Aug 2022

Resources

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
2,173 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02601157
Sponsor's protocol ID
HOST-IDEA trial
Acronym
HOST-IDEA
Status last verified
Jan 2023
First submitted
7 Nov 2015
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Han JK, Hwang D, Yang S, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Kim SY, Park SH, Han SH, Kim SH, Shin S, Park K, Lee SJ, Kim JW, Lee N, Kim HS. Abbreviated dual antiplatelet therapy after percutaneous coronary intervention with ultrathin-strut drug-eluting stents in South Korea: 3-year outcomes of the multicentre, randomised HOST-IDEA trial. EClinicalMedicine. 2025 Dec 18;91:103698. doi: 10.1016/j.eclinm.2025.103698. eCollection 2026 Jan.

    PubMed 41509615

  • Han JK, Lee K, Park SH, Yang S, Hwang D, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Park SH, Han SH, Kim SH, Kim YH, Lee N, Lee SJ, Shin S, Kim HS. Short-Term DAPT After Complex PCI With Third-Generation DES: A Post Hoc Analysis of the HOST-IDEA Trial. Circ Cardiovasc Interv. 2025 May;18(5):e014623. doi: 10.1161/CIRCINTERVENTIONS.124.014623. Epub 2025 Mar 31.

    PubMed 40160090

  • Han JK, Yang S, Hwang D, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Cho JM, Cho J, Bang DW, Lee JH, Lee HC, Kim KJ, Chun WJ, Seo WW, Park WJ, Park SM, Kim JW, Kim HS. Biodegradable Polymer Versus Polymer-Free Ultrathin Sirolimus-Eluting Stents: Analysis of the Stent Arm Registry From the HOST-IDEA Randomized Trial. Circ Cardiovasc Interv. 2024 Jul;17(7):e013585. doi: 10.1161/CIRCINTERVENTIONS.123.013585. Epub 2024 May 24.

    PubMed 38786579

  • Han JK, Hwang D, Yang S, Park SH, Kang J, Yang HM, Park KW, Kang HJ, Koo BK, Hur SH, Kim W, Kim SY, Park SH, Han SH, Kim SH, Shin S, Kim YH, Park K, Lee N, Lee SJ, Kim JW, Kim HS. Comparison of 3- to 6-Month Versus 12-Month Dual Antiplatelet Therapy After Coronary Intervention Using the Contemporary Drug-Eluting Stents With Ultrathin Struts: The HOST-IDEA Randomized Clinical Trial. Circulation. 2023 May 2;147(18):1358-1368. doi: 10.1161/CIRCULATIONAHA.123.064264. Epub 2023 Mar 5.

    PubMed 36871230

  • Kim CH, Han JK, Yang HM, Park KW, Lee HY, Kang HJ, Koo BK, Lee N, Cha TJ, Yang TH, Jeong MH, Yoon MH, Lee SU, Lee SJ, Kim JW, Cho JM, Han KR, Pyun WB, Kim HS. Study protocol for a randomised controlled trial: harmonising 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. BMJ Open. 2017 Oct 11;7(10):e016617. doi: 10.1136/bmjopen-2017-016617.

    PubMed 29025834

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 3-months DAPT and 1-year DAPT in people with Stable Angina and Unstable Angina, run by Seoul National University Hospital at 12 sites 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 1 inclusion and 1 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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. 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?

NACEs (net adverse clinical events) (time frame: post-stenting 12 months). 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 NCT02601157, which also lists 5 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 10 Jan 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in