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)

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Abbott; Boston Scientific Korea Co. Ltd; Dio; Terumo Corporation
• Treatments: Everolimus; Prasugrel Hydrochloride; Sirolimus

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).