Ignite Creation Date:
2024-05-05 @ 11:10 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01267734
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2010-12-27
Brief Title:
Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety EffectiveneSS of Drug-ElUting Stents Anti-platelet REgimen
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Comparison of the Efficacy and Safety of New Platform Everolimus-eluting Coronary Stent System Promus Element With Zotarolimus-eluting Coronary Stent System Endeavor Resolute and Triple Anti-platelet Therapy With Double-dose Clopidogrel Anti-platelet Therapy in Patients With Coronary Heart Disease
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
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:
HOST-ASSURE
Brief Summary:
Objectives
1 To compare the safety and long-term effectiveness of coronary stenting with the new platform Everolimus-Eluting coronary stenting system EECSS Promus Element compared with the Zotarolimus-Eluting coronary stenting system ZECSS Endeavor Resolute in patients with coronary heart disease CHD
2 To determine the short-term efficacy and safety of triple anti-platelet therapy TAT Aspirin 100mg qd Clopidogrel 75mg qd and Cilostazol 100mg bid compared with double-dose clopidogrel dual anti-platelet therapy DDAT Aspirin 100mg qd and Clopidogrel 150mg qd in patients undergoing percutaneous coronary intervention PCI with drug-eluting stents DES
Study design Prospective open-label 2-by-2 multifactorial randomized multicenter trial to test the following in CHD patients
1 Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure TLF
2 Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent EECSS vs ZECSS and the type anti-platelet regimen TAT vs DDAT Randomization will also be stratified per presence of DM
Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea
Patient follow-up Clinical follow-up will occur at 1 3 12 24 36 months after the procedure Angiographical follow-up will be recommended to all participants at 13 months after the procedure Investigator or designee may conduct follow-up as telephone contacts or office visits
Primary endpoint
1 Target lesion failure TLF defined as a composite of cardiac death target vessel-related myocardial infarction MI and ischemia-driven target lesion revascularization TLR up to 12 months for the stent arm
2 Net clinical outcome defined as a composite of cardiac death nonfatal MI CVA and major bleeding by PLATO criteria at 1 month for the anti-platelet arm
1 To compare the safety and long-term effectiveness of coronary stenting with the new platform Everolimus-Eluting coronary stenting system EECSS Promus Element compared with the Zotarolimus-Eluting coronary stenting system ZECSS Endeavor Resolute in patients with coronary heart disease CHD
2 To determine the short-term efficacy and safety of triple anti-platelet therapy TAT Aspirin 100mg qd Clopidogrel 75mg qd and Cilostazol 100mg bid compared with double-dose clopidogrel dual anti-platelet therapy DDAT Aspirin 100mg qd and Clopidogrel 150mg qd in patients undergoing percutaneous coronary intervention PCI with drug-eluting stents DES
Study design Prospective open-label 2-by-2 multifactorial randomized multicenter trial to test the following in CHD patients
1 Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure TLF
2 Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent EECSS vs ZECSS and the type anti-platelet regimen TAT vs DDAT Randomization will also be stratified per presence of DM
Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea
Patient follow-up Clinical follow-up will occur at 1 3 12 24 36 months after the procedure Angiographical follow-up will be recommended to all participants at 13 months after the procedure Investigator or designee may conduct follow-up as telephone contacts or office visits
Primary endpoint
1 Target lesion failure TLF defined as a composite of cardiac death target vessel-related myocardial infarction MI and ischemia-driven target lesion revascularization TLR up to 12 months for the stent arm
2 Net clinical outcome defined as a composite of cardiac death nonfatal MI CVA and major bleeding by PLATO criteria at 1 month for the anti-platelet arm
Detailed Description:
Secondary endpoint
1 Clinical and laboratory endpoint at 1 month All death and cardiac death Myocardial infarction q wave and non-q wave Stent thrombosis definite and possible CVA hemorrhagic and non-hemorrhagic Bleeding major and minor VerifyNow ASA and VerifyNow P2Y12
2 Clinical endpoint at 12 months All death and cardiac death Target vessel-related MI and all MI q wave and non-q wave Target vessellesion revascularization ischemia-driven and all Stent thrombosis definitepossibleprobable Net clinical outcome including bleeding major and minor Acute success of procedure device lesion and procedure
3 Angiographic including IVUS or OCT endpoint at 13 months In-stent In-segment late loss In-stent In-segment diameter stenosis Angiographic pattern of restenosis Neointimal volume neointimal volume and volume obstruction on IVUS or OCT Degree of stent strut endothelialization on OCT
1 Clinical and laboratory endpoint at 1 month All death and cardiac death Myocardial infarction q wave and non-q wave Stent thrombosis definite and possible CVA hemorrhagic and non-hemorrhagic Bleeding major and minor VerifyNow ASA and VerifyNow P2Y12
2 Clinical endpoint at 12 months All death and cardiac death Target vessel-related MI and all MI q wave and non-q wave Target vessellesion revascularization ischemia-driven and all Stent thrombosis definitepossibleprobable Net clinical outcome including bleeding major and minor Acute success of procedure device lesion and procedure
3 Angiographic including IVUS or OCT endpoint at 13 months In-stent In-segment late loss In-stent In-segment diameter stenosis Angiographic pattern of restenosis Neointimal volume neointimal volume and volume obstruction on IVUS or OCT Degree of stent strut endothelialization on OCT
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