Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases III Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST III Trial - REDUCE POLYTECH RCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by Seoul National University Hospital
Sponsor:
Collaborators:
Boston Scientific Korea Co. Ltd
Dio
Terumo Corporation
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT02193971
First received: July 13, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose
  • Study objectives

    1. To compare the safety and long-term efficacy of coronary stenting with biostable polymer everolimus-eluting coronary stent system (Promus PremierTM) with biodegradable polymer biolimus-eluting coronary stent system (Biomatrix®, Biomatrix Flex® and Nobori®) 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 everolimus-eluting stent (Promus PremierTM) compared with biodegradable polymer biolimus-eluting coronary stent system (Biomatrix®,Biomatrix Flex® and Nobori®) 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 Intervention Phase
Acute Coronary Syndrome
Device: Everolimus-eluting stenting
Device: biodegradable polymer biolimus-eluting stent
Drug: Prasugrel 5mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases III Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST III Trial - REDUCE POLYTECH RCT) Comparison of the Efficacy and Safety of Biostable Polymer Everolimus-eluting Coronary Stent System (Promus PremierTM) With Biodegradable Polymer Biolimus-eluting Coronary Stent System (Biomatrix®, Biomatrix Flex® and Nobori®) and Conventional Dose Prasugrel Therapy With Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated With Percutaneous Coronary Intervention.

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

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

Estimated Enrollment: 3384
Study Start Date: July 2014
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PtCr-EES with prasugrel 10mg daily
PtCr-EES with prasugrel 10mg daily
Device: Everolimus-eluting stenting
Other Name: Promus premier
Active Comparator: PtCr-EES with prasugrel 5mg daily
PtCr-EES with prasugrel 5mg daily
Device: Everolimus-eluting stenting
Other Name: Promus premier
Drug: Prasugrel 5mg
Use prasugrel 5mg daily for maintaning dose
Other Name: Prasugrel
Experimental: BP-BES with prasugrel 10mg daily
BP-BES with prasugrel 10mg daily
Device: biodegradable polymer biolimus-eluting stent
Other Names:
  • Biomatrix
  • Biomatrix Flex
  • Nobori
Experimental: BP-BES with prasugrel 5mg daily
BP-BES with prasugrel 5mg daily
Device: biodegradable polymer biolimus-eluting stent
Other Names:
  • Biomatrix
  • Biomatrix Flex
  • Nobori
Drug: Prasugrel 5mg
Use prasugrel 5mg daily for maintaning dose
Other Name: Prasugrel

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.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 Promus Premier or Biomatrix® Biomatrix Flex® or Nobori®.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Hyo-Soo Kim, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02193971     History of Changes
Other Study ID Numbers: HOST III REDUCE POLYTECH RCT
Study First Received: July 13, 2014
Last Updated: July 17, 2014
Health Authority: Republic of Korea : Institutional Review Board

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Disease
Pathologic Processes
Everolimus
Sirolimus
Prasugrel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on September 16, 2014