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 | Completed Phase 4 DMC

• 1 other identifier: HOST REDUCE POLYTECH RCT
• Study Type: interventional
• Target: 3,429
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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
3. 3.Study design : Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients
4. 4.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
5. 5.Non-inferiority of 5 mg compared to 10 mg dose of prasugrel maintenance in terms of major adverse cardiovascular events

Conditions

Acute Coronary Syndrome

Keywords

Acute coronary syndrome; Drug eluting stent; Everolimus; Prasugrel

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

BS-DES with prasugrel 10mg daily

ACTIVE COMPARATOR

BS-DES with prasugrel 10mg daily

Device: BS-DES (Biostable polymer drug-eluting stent)

BS-DES with prasugrel 5mg daily

ACTIVE COMPARATOR

BS-DES with prasugrel 5mg daily

Device: BS-DES (Biostable polymer drug-eluting stent); Drug: Prasugrel 5mg

BD-DES with prasugrel 10mg daily

EXPERIMENTAL

BD-DES with prasugrel 10mg daily

Device: BD-DES (Biodegradable polymer drug-eluting stent)

BD-DES with prasugrel 5mg daily

EXPERIMENTAL

BD-DES with prasugrel 5mg daily

Device: BD-DES (Biodegradable polymer drug-eluting stent); Drug: Prasugrel 5mg

Interventions

BS-DES (Biostable polymer drug-eluting stent) DEVICE

Also known as: Promus Premier, Xience Alpine, Resolute Onyx

BS-DES with prasugrel 10mg daily; BS-DES with prasugrel 5mg daily

BD-DES (Biodegradable polymer drug-eluting stent) DEVICE

Also known as: Biomatrix, Biomatrix Flex, Nobori, Ultimaster, Synergy, Orsiro

BD-DES with prasugrel 10mg daily; BD-DES with prasugrel 5mg daily

Prasugrel 5mg DRUG

Use prasugrel 5mg daily for maintaning dose

Also known as: Prasugrel

BD-DES with prasugrel 5mg daily; BS-DES with prasugrel 5mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Boston Scientific Korea Co. Ltd: collaborator
• Dio: collaborator
• Terumo Corporation: collaborator
• Abbott: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (6)

• Kang J, Hwang D, Park KW, Han JK, Yang HM, Kang HJ, Koo BK, Lim YH, Rhew JY, Chun KJ, Lee BK, Kim S, Bae JW, Kim HS, Host Reduce Polytech Rct Trial Investigators OBOT. Durable-polymer versus biodegradable-polymer drug-eluting stents in acute coronary syndromes: three-year outcomes of the HOST REDUCE POLYTECH RCT Trial. EuroIntervention. 2024 Jun 17;20(12):e750-e759. doi: 10.4244/EIJ-D-23-01053.

  PMID: 38887886 RESULT

• Lee KS, Park KH, Park KW, Rha SW, Hwang D, Kang J, Han JK, Yang HM, Kang HJ, Koo BK, Lee NH, Rhew JY, Chun KJ, Lim YH, Bong JM, Bae JW, Lee BK, Kim SY, Shin WY, Lim HS, Park K, Kim HS. Prasugrel dose de-escalation in diabetic patients with acute coronary syndrome receiving percutaneous coronary intervention: results from the HOST-REDUCE-POLYTECH-ACS trial. Eur Heart J Cardiovasc Pharmacother. 2023 Apr 10;9(3):262-270. doi: 10.1093/ehjcvp/pvad008.

  PMID: 36715152 DERIVED

• Hwang D, Lim YH, Park KW, Chun KJ, Han JK, Yang HM, Kang HJ, Koo BK, Kang J, Cho YK, Hong SJ, Kim S, Jo SH, Kim YH, Kim W, Lee SY, Kim YD, Oh SK, Lee JH, Kim HS; HOST-RP-ACS investigators. Prasugrel Dose De-escalation Therapy After Complex Percutaneous Coronary Intervention in Patients With Acute Coronary Syndrome: A Post Hoc Analysis From the HOST-REDUCE-POLYTECH-ACS Trial. JAMA Cardiol. 2022 Apr 1;7(4):418-426. doi: 10.1001/jamacardio.2022.0052.

  PMID: 35262625 DERIVED

• Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Kim SY, Park KH, Rha SW, Shin WY, Lim HS, Park K, Park KW; HOST-REDUCE-POLYTECH-ACS Trial Investigators. Durable Polymer Versus Biodegradable Polymer Drug-Eluting Stents After Percutaneous Coronary Intervention in Patients with Acute Coronary Syndrome: The HOST-REDUCE-POLYTECH-ACS Trial. Circulation. 2021 Mar 16;143(11):1081-1091. doi: 10.1161/CIRCULATIONAHA.120.051700. Epub 2020 Nov 18.

  PMID: 33205662 DERIVED

• Kim HS, Kang J, Hwang D, Han JK, Yang HM, Kang HJ, Koo BK, Rhew JY, Chun KJ, Lim YH, Bong JM, Bae JW, Lee BK, Park KW; HOST-REDUCE-POLYTECH-ACS investigators. Prasugrel-based de-escalation of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (HOST-REDUCE-POLYTECH-ACS): an open-label, multicentre, non-inferiority randomised trial. Lancet. 2020 Oct 10;396(10257):1079-1089. doi: 10.1016/S0140-6736(20)31791-8. Epub 2020 Aug 31.

  PMID: 32882163 DERIVED

• Lee JM, Jung JH, Park KW, Shin ES, Oh SK, Bae JW, Rhew JY, Lee N, Kim DB, Kim U, Han JK, Lee SE, Yang HM, Kang HJ, Koo BK, Kim S, Cho YK, Shin WY, Lim YH, Rha SW, Kim SY, Lee SY, Kim YD, Chae IH, Cha KS, Kim HS. Harmonizing Optimal Strategy for Treatment of coronary artery diseases--comparison of REDUCtion of prasugrEl dose or POLYmer TECHnology in ACS patients (HOST-REDUCE-POLYTECH-ACS RCT): study protocol for a randomized controlled trial. Trials. 2015 Sep 15;16:409. doi: 10.1186/s13063-015-0925-5.

  PMID: 26374625 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Hyo-Soo Kim, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: July 13, 2014
• First Posted: July 18, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2024
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

KR (1)