Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial)

Study Overview
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Brief Summary
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Study objectives To compare the safety and long-term efficacy of coronary stenting with biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in patients with acute coronary syndrome To compare the efficacy and safety of 5 mg prasugrel maintenance therapy compared with 10 mg prasugrel maintenance therapy in patients with acute coronary syndrome undergoing percutaneous coronary intervention Study design : Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients Non-inferiority of biostable polymer drug-eluting stent (Promus PremierTM, Xience Alpine®, Resolute Onyx®) compared with biodegradable polymer drug-eluting stent (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®, Synergy ® and Orsiro®) in terms of patient-oriented composite outcome Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events

Detailed Description
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About 3400 patients derived from a population of Korean patients with acute coronary syndrome receiving percutaneous coronary intervention will be enrolled in the present trial. All patients will receive a loading dose of aspirin (300 mg) and prasugrel (60 mg bolus) will be administered. Sixty-mg-loading dose of prasugrel will be given regardless of pretreated antiplatelet agents (clopidogrel, ticagrelor, or cilostazol). However, in patients who already loaded with other antiplatelet agents (clopidigrel, ticagrelor, or cilostazol), reduced dose (30mg) or omission of prasugrel loading is acceptable. Following angiography, patients with significant diameter stenosis >50% of coronary artery or graft vessel by visual estimation that have documented myocardial ischemia or symptoms of angina, and have lesions that are eligible for coronary intervention without any exclusion criteria, will be randomized 1:1 to either receive either BS-DES or BD-DES group. At 1-month clinical follow-up, patients eligible for antiplatelet comparison will be additionally randomized 1:1 to either receive the reduce dose of prasugrel (5 mg daily) or conventional dose (10 mg daily). The exclusion criteria (age ≥75 years, body weight <60 kg, or history of TIA or stroke) is classified as observational cohort. Post-PCI, dual antiplatelet therapy is recommended for at least 1 year. Follow-up data will be collected until 3-year after index procedure.

Official Title
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Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial) Comparison of the Efficacy and Safety of Biostable Polymer DES (Promus PremierTM, Xience Alpine®, and Resolute Onyx®) With Biodegradable Polymer DES (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®,Synergy®, and Orsiro®)and Conventional Dose Prasugrel Therapy With Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated With Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Device: BS-DES (Biostable polymer drug-eluting stent)
* Device: BD-DES (Biodegradable polymer drug-eluting stent)
* Drug: Prasugrel 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be ≥ 18 years Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. Subject must have a culprit lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation Subject must have clinical diagnosis of acute coronary syndrome Exclusion Criteria: Following patients will be enrolled in stent comparison, but excluded from antiplatelet comparison. They will be classified as observational cohort. Subjects ≥75 years Body weight <60 kg History of TIA or stroke The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Biolimus, Everolimus, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled.) Patients with active pathologic bleeding Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months. Systemic (intravenous) Biolimus, or everolimus use within 12 months. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study. History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BS-DES with prasugrel 10mg daily<br>BS-DES with prasugrel 10mg daily | Device: BS-DES (Biostable polymer drug-eluting stent)<br> <br> * Other names: Resolute Onyx;|
| Active Comparator: BS-DES with prasugrel 5mg daily<br>BS-DES with prasugrel 5mg daily | Device: BS-DES (Biostable polymer drug-eluting stent)<br> <br> * Other names: Resolute Onyx;Drug: Prasugrel 5mg<br>* Use prasugrel 5mg daily for maintaning dose<br>* Other names: Prasugrel;|
| Experimental: BD-DES with prasugrel 10mg daily<br>BD-DES with prasugrel 10mg daily | Device: BD-DES (Biodegradable polymer drug-eluting stent)<br> <br> * Other names: Orsiro;|
| Experimental: BD-DES with prasugrel 5mg daily<br>BD-DES with prasugrel 5mg daily | Device: BD-DES (Biodegradable polymer drug-eluting stent)<br> <br> * Other names: Orsiro;Drug: Prasugrel 5mg<br>* Use prasugrel 5mg daily for maintaning dose<br>* Other names: Prasugrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization |  | 12months | 
| Antiplatelet arm : major adverse cardiovascular event (MACE), defined as a composite of all death, MI, stent thrombosis, repeat revascularization, CVA, and BARC class ≥2 bleeding |  | 12months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute coronary syndrome, Drug eluting stent, Everolimus, Prasugrel