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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)

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ClinicalTrials.gov Identifier: NCT02193971
Recruitment Status : Active, not recruiting
First Posted : July 18, 2014
Last Update Posted : January 30, 2020
Sponsor:
Collaborators:
Boston Scientific Korea Co. Ltd
Dio
Terumo Corporation
Abbott
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 13, 2014
First Posted Date  ICMJE July 18, 2014
Last Update Posted Date January 30, 2020
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2014)
  • Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization [ Time Frame: 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 [ Time Frame: 12months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
Brief 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Device: BS-DES (Biostable polymer drug-eluting stent)
    Other Names:
    • Promus Premier
    • Xience Alpine
    • Resolute Onyx
  • Device: BD-DES (Biodegradable polymer drug-eluting stent)
    Other Names:
    • Biomatrix
    • Biomatrix Flex
    • Nobori
    • Ultimaster
    • Synergy
    • Orsiro
  • Drug: Prasugrel 5mg
    Use prasugrel 5mg daily for maintaning dose
    Other Name: Prasugrel
Study Arms  ICMJE
  • Active Comparator: BS-DES with prasugrel 10mg daily
    BS-DES with prasugrel 10mg daily
    Intervention: Device: BS-DES (Biostable polymer drug-eluting stent)
  • Active Comparator: BS-DES with prasugrel 5mg daily
    BS-DES with prasugrel 5mg daily
    Interventions:
    • Device: BS-DES (Biostable polymer drug-eluting stent)
    • Drug: Prasugrel 5mg
  • Experimental: BD-DES with prasugrel 10mg daily
    BD-DES with prasugrel 10mg daily
    Intervention: Device: BD-DES (Biodegradable polymer drug-eluting stent)
  • Experimental: BD-DES with prasugrel 5mg daily
    BD-DES with prasugrel 5mg daily
    Interventions:
    • Device: BD-DES (Biodegradable polymer drug-eluting stent)
    • Drug: Prasugrel 5mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2014)
3384
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02193971
Other Study ID Numbers  ICMJE HOST REDUCE POLYTECH RCT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Boston Scientific Korea Co. Ltd
  • Dio
  • Terumo Corporation
  • Abbott
Investigators  ICMJE
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP