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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 : Recruiting
First Posted : July 18, 2014
Last Update Posted : March 9, 2018
Sponsor:
Collaborators:
Boston Scientific Korea Co. Ltd
Dio
Terumo Corporation
Abbott
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Device: BS-DES (Biostable polymer drug-eluting stent) Device: BD-DES (Biodegradable polymer drug-eluting stent) Drug: Prasugrel 5mg Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 3384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Prasugrel

Arm Intervention/treatment
Active Comparator: BS-DES with prasugrel 10mg daily
BS-DES with prasugrel 10mg daily
Device: BS-DES (Biostable polymer drug-eluting stent)
Other Names:
  • Promus Premier
  • Xience Alpine
  • Resolute Onyx

Active Comparator: BS-DES with prasugrel 5mg daily
BS-DES with prasugrel 5mg daily
Device: BS-DES (Biostable polymer drug-eluting stent)
Other Names:
  • Promus Premier
  • Xience Alpine
  • Resolute Onyx

Drug: Prasugrel 5mg
Use prasugrel 5mg daily for maintaning dose
Other Name: Prasugrel

Experimental: BD-DES with prasugrel 10mg daily
BD-DES with prasugrel 10mg daily
Device: BD-DES (Biodegradable polymer drug-eluting stent)
Other Names:
  • Biomatrix
  • Biomatrix Flex
  • Nobori
  • Ultimaster
  • Synergy
  • Orsiro

Experimental: BD-DES with prasugrel 5mg daily
BD-DES with prasugrel 5mg daily
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




Primary Outcome Measures :
  1. Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization [ Time Frame: 12months ]
  2. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193971


Contacts
Contact: Kyung-Woo Park, MD, PhD 82-2-2072-0244 kwparkmd@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Kyung Woo Park, MD, PhD    82-2-2072-0244    kwparkmd@snu.ac.kr   
Contact: Hyo-Soo Kim, MD, PhD    82-2-2072-2226    hyosoo@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Boston Scientific Korea Co. Ltd
Dio
Terumo Corporation
Abbott
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02193971     History of Changes
Other Study ID Numbers: HOST REDUCE POLYTECH RCT
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: October 2017

Keywords provided by Seoul National University Hospital:
Acute coronary syndrome
Drug eluting stent
Everolimus
Prasugrel

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Syndrome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Prasugrel Hydrochloride