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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

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.


Condition or disease Intervention/treatment Phase
Stable Angina Unstable Angina Non-ST Segment Elevation Myocardial Infarction Device: CX-ISAR Device: Orsiro Drug: 3-months DAPT Drug: 1-year DAPT Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2152 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : November 2022

Arm Intervention/treatment
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.
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

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.
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: 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

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.
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

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

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.
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

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




Primary Outcome Measures :
  1. 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

  2. NACEs (net adverse clinical events) [ Time Frame: post-stenting 12 months ]
    TLF + definite or probable stent thrombosis, major bleeding


Secondary Outcome Measures :
  1. definite or probable stent thrombosis and major bleeding [ Time Frame: post-stenting 12 months ]
    stent thrombosis or major bleeding as a safety measure



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601157


Contacts
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Contact: Hyo-Soo Kim, M.D., Ph.D. 82-2-2072-2226 hyosoo@snu.ac.kr

Locations
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Korea, Republic of
Busan Paik Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: Tae-Hyun Yang, M.D., PhD       yangthmd@naver.com   
Kosin University Gospel Hospital Not yet recruiting
Busan, Korea, Republic of
Contact: Tae-Joon Cha, M.D., PhD       chatjn@gmail.com   
SoonChunHyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: Seung Jin Lee, M.D., PhD       drlsj3@gmail.com   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Myung-Ho Jeong, M.D., PhD       mhjeong@chonnam.ac.kr   
Gwangju Christian Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Seung Uk Lee, M.D., PhD       cardiosu@hanmail.net   
Ewha Womans University Medical Center Mokdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Wook Bum Pyun, MD. PhD.       pwb423@ewha.ac.kr   
Hallym University Kangdong Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyu-Rock Han, MD. PhD.       krheart@hallym.or.kr   
Kangnam Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Namho Lee, M.D., PhD       namholee@hallym.or.kr   
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jin Won Kim, M.D., PhD       kjwmm@korea.ac.kr   
Kyung Hee University Hospital at Gangdong Not yet recruiting
Seoul, Korea, Republic of
Contact: Jin-Man Cho, M.D., PhD       aceri@medimail.co.kr   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyo-Soo Kim, M.D., PhD    82-2-2072-2226    hyosoo@snu.ac.kr   
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Myeong-Ho Yoon, M.D., PhD       yoonmh65@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital
B. Braun Korea Co., Ltd.
Investigators
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Study Chair: Hyo-Soo Kim, M.D., Ph.D. Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyo-Soo Kim, Director of Cardiac Catheterization Laboratory & Coronary Intervention, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02601157     History of Changes
Other Study ID Numbers: HOST-IDEA trial
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
stent
polymer
antiplatelet therapy
clopidogrel
Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Angina, Stable
Angina, Unstable
Coronary Stenosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease
Aspirin
Sirolimus
Everolimus
Clopidogrel
Ticagrelor
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs