Ignite Creation Date:
2024-05-06 @ 3:03 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02193971
Status:
UNKNOWN
Last Update Posted:
2020-01-30
First Post:
2014-07-13
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
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
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 UltimasterSynergy and Orsiroand Conventional Dose Prasugrel Therapy With Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated With Percutaneous Coronary Intervention
Status:
UNKNOWN
Status Verified Date:
2020-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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 11 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
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 11 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None