Clinical trial NCT02601157: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stable Angina
Unstable Angina
Non-ST Segment Elevation Myocardial Infarction
Keywords: stent
polymer
antiplatelet therapy
clopidogrel
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: B. Braun Korea Co., Ltd.
First posted: 2015-11-10
Enrollment: 2173
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NACEs (net adverse clinical events)
timeFrame: post-stenting 12 months
Secondary outcomes:
measure: TLF (target lesion failure)
timeFrame: post-stenting 12 months
measure: Major bleeding
timeFrame: post-stenting 12 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheonan
country: Korea, Republic of
facility: SoonChunHyang University Cheonan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Christian Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Medical Center Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: 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.