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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)

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ClinicalTrials.gov Identifier: NCT02601157
Recruitment Status : Recruiting
First Posted : November 10, 2015
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
B. Braun Korea Co., Ltd.
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE November 7, 2015
First Posted Date  ICMJE November 10, 2015
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE December 2015
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2015)
  • TLF (target lesion failure) [ Time Frame: post-stenting 12 months ]
    composite end-point of cardiac death, target lesion-related non-fatal myocardial infarction, clinically-driven target lesion revascularization
  • NACEs (net adverse clinical events) [ Time Frame: post-stenting 12 months ]
    TLF + definite or probable stent thrombosis, major bleeding
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02601157 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2015)
definite or probable stent thrombosis and major bleeding [ Time Frame: post-stenting 12 months ]
stent thrombosis or major bleeding as a safety measure
Original Secondary Outcome Measures  ICMJE Same as current
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 - Coronary Intervention With Next Generation Drug-Eluting Stent Platforms and Abbreviated Dual Antiplatelet Therapy (HOST-IDEA) Trial
Official Title  ICMJE 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
Brief 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.

With a 2x2 factorial design for patients of stable angina or silent ischemia, the investigators formulate a head-to-head randomized comparison between sirolimus-eluting Orsiro stent with biodegradable polymer and polymer-free stent platform with the same antiproliferative agent, Coroflex ISAR stent system. At the same time, clopidogrel 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. 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 primary efficacy outcome. And in addition to TLF, definite or probable stent thrombosis and major bleeding events will also be counted as a composite outcome of net adverse clinical events (NACEs) to comprehensively adjudicate the efficacy and safety outcomes according to the difference of DAPT duration.

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stable Angina
  • Unstable Angina
  • Non-ST Segment Elevation Myocardial Infarction
Intervention  ICMJE
  • Device: CX-ISAR
    Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
    Other Name: Coroflex ISAR sirolimus-eluting stents
  • Device: Orsiro
    Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, abluminal coatings with biodegradable polymer.
    Other Name: Orsiro sirolimus-eluting stents
  • 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 Name: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 3-months schedule after the coronary stenting
  • Drug: 1-year DAPT
    Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting
    Other Name: Aspirin + P2Y12 inhibitor (clopidogrel/prasugrel/ticagrelor) for 1-year schedule after the coronary stenting
Study Arms  ICMJE
  • Experimental: Orsiro SES/3-months DAPT
    As an one of experimental arms in 2x2 factorial design, patients allocated to this group will be implanted with Orisro sirolimus-eluting stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.
    Interventions:
    • Device: Orsiro
    • Drug: 3-months DAPT
  • Active Comparator: Orsiro SES/1-year DAPT
    As an one of comparator arms in 2x2 factorial design, patients allocated to this group will be implanted with Orisro sirolimus-eluting stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.
    Interventions:
    • Device: Orsiro
    • Drug: 1-year DAPT
  • Experimental: CX-ISAR/3-months DAPT
    As an one of experimental arms in 2x2 factorial design, patients allocated to this group will be implanted with Coroflex ISAR (CX-ISAR) sirolimus-eluting stents for their coronary lesions, and then will be followed with 3-month dual antiplatelet therapy (DAPT) schedule.
    Interventions:
    • Device: CX-ISAR
    • Drug: 3-months DAPT
  • Active Comparator: CX-ISAR/1-year DAPT
    As an one of comparator arms in 2x2 factorial design, patients allocated to this group will be implanted with Coroflex ISAR (CX-ISAR) sirolimus-eluting stents for their coronary lesions, and then will be followed with 1-year dual antiplatelet therapy (DAPT) schedule.
    Interventions:
    • Device: CX-ISAR
    • Drug: 1-year DAPT
Publications * 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. Erratum in: BMJ Open. 2018 Feb 10;8(2):e016617corr1.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2016)
2152
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2015)
2132
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hyo-Soo Kim, M.D., Ph.D. 82-2-2072-2226 hyosoo@snu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02601157
Other Study ID Numbers  ICMJE HOST-IDEA 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 B. Braun Korea Co., Ltd.
Investigators  ICMJE
Study Chair: Hyo-Soo Kim, M.D., Ph.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date May 2017

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