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)
NCT02193971 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3429
Last updated 2026-04-27
Summary
* Study objectives
1. 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
2. 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
1. 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
2. Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events
Conditions
- Acute Coronary Syndrome
Interventions
- DEVICE
-
BS-DES (Biostable polymer drug-eluting stent)
- DEVICE
-
BD-DES (Biodegradable polymer drug-eluting stent)
- DRUG
-
Prasugrel 5mg
Use prasugrel 5mg daily for maintaning dose
Sponsors & Collaborators
-
Boston Scientific Korea Co. Ltd
collaborator INDUSTRY -
Dio
collaborator INDUSTRY -
Terumo Corporation
collaborator INDUSTRY - collaborator INDUSTRY
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Hyo-Soo Kim, MD, PhD · Seoul National University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-31
- Primary Completion
- 2020-10-31
- Completion
- 2024-01-31
Countries
- South Korea
Study Locations
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