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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)

Primary Purpose

Acute Coronary Syndrome

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

BS-DES (Biostable polymer drug-eluting stent)

BD-DES (Biodegradable polymer drug-eluting stent)

Prasugrel 5mg

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute coronary syndrome, Drug eluting stent, Everolimus, Prasugrel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

BS-DES with prasugrel 10mg daily

BS-DES with prasugrel 5mg daily

BD-DES with prasugrel 10mg daily

BD-DES with prasugrel 5mg daily

Arm Description

BS-DES with prasugrel 10mg daily

BS-DES with prasugrel 5mg daily

BD-DES with prasugrel 10mg daily

BD-DES with prasugrel 5mg daily

Outcomes

Primary Outcome Measures

Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02193971

First Posted

July 13, 2014

Last Updated

January 28, 2020

Sponsor

Seoul National University Hospital

Collaborators

Boston Scientific Korea Co. Ltd, Dio, Terumo Corporation, Abbott

1. Study Identification

Unique Protocol Identification Number

NCT02193971

Brief Title

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)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

July 2014 (undefined)

Primary Completion Date

October 2020 (Anticipated)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

Collaborators

Boston Scientific Korea Co. Ltd, Dio, Terumo Corporation, Abbott

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

Acute coronary syndrome, Drug eluting stent, Everolimus, Prasugrel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BS-DES with prasugrel 10mg daily

Arm Type

Active Comparator

Arm Description

BS-DES with prasugrel 10mg daily

Arm Title

BS-DES with prasugrel 5mg daily

Arm Type

Active Comparator

Arm Description

BS-DES with prasugrel 5mg daily

Arm Title

BD-DES with prasugrel 10mg daily

Arm Type

Experimental

Arm Description

BD-DES with prasugrel 10mg daily

Arm Title

BD-DES with prasugrel 5mg daily

Arm Type

Experimental

Arm Description

BD-DES with prasugrel 5mg daily

Intervention Type

Device

Intervention Name(s)

BS-DES (Biostable polymer drug-eluting stent)

Other Intervention Name(s)

Promus Premier, Xience Alpine, Resolute Onyx

Intervention Type

Device

Intervention Name(s)

BD-DES (Biodegradable polymer drug-eluting stent)

Other Intervention Name(s)

Biomatrix, Biomatrix Flex, Nobori, Ultimaster, Synergy, Orsiro

Intervention Type

Drug

Intervention Name(s)

Prasugrel 5mg

Other Intervention Name(s)

Prasugrel

Intervention Description

Use prasugrel 5mg daily for maintaning dose

Primary Outcome Measure Information:

Title

Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization

Time Frame

12months

Title

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

Time Frame

12months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hyo-Soo Kim, MD, PhD

Organizational Affiliation

Seoul National University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

36000257

Citation

Hwang D, Lim HS, Park KW, Shin WY, Kang J, Han JK, Yang HM, Kang HJ, Koo BK, Cho YK, Hong SJ, Kim S, Jo SH, Kim YH, Kim W, Lee SY, Oh SK, Kim DB, Kim HS. Durable polymer versus biodegradable polymer drug-eluting stents in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention: a post hoc analysis of the HOST-REDUCE-POLYTECH-ACS trial. EuroIntervention. 2022 Dec 2;18(11):e910-e919. doi: 10.4244/EIJ-D-22-00372.

Results Reference

derived

PubMed Identifier

35262625

Citation

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.

Results Reference

derived

PubMed Identifier

33205662

Citation

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.

Results Reference

derived

PubMed Identifier

32882163

Citation

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.

Results Reference

derived

PubMed Identifier

26374625

Citation

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.

Results Reference

derived

Learn more about this trial

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)

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