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

  • STATUS
    Recruiting
  • participants needed
    2152
  • sponsor
    Seoul National University Hospital
Updated on 21 January 2021
stenosis
aspirin
sirolimus
myocardial infarction
angina pectoris
infarct
clopidogrel
antiplatelet therapy
ischemia
coronary artery stenosis
dapt
stenotic
cardiac death

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.

Description

Every antiplatelet-nave 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.

Details
Condition Angina Pectoris, Unstable angina, Stable Angina, Stable Angina Pectoris, Non-ST Segment Elevation Myocardial Infarction, Non ST Segment Elevation Myocardial Infarction, Angina, unstable angina pectoris
Treatment Orsiro, CX-ISAR, 3-months DAPT, 1-year DAPT
Clinical Study IdentifierNCT02601157
SponsorSeoul National University Hospital
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Stable Angina or Unstable angina or Non-ST Segment Elevation Myocardial Infarction?
Do you have any of these conditions: Stable Angina Pectoris or Unstable angina or Non ST Segment Elevation Myocardial Infarction or Angina or Stable Angina or Angina Pectoris or Non-ST Se...?
Patients with de novo stenotic lesions who are suitable for coronary stenting with drug-eluting stent

Exclusion Criteria

\. 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
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