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JRCT ID: jRCTs052220145

Registered date:05/01/2023

Prasugrel Monotherapy Following PrImary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	ST-Elevation Myocardial Infarction
Date of first enrollment	07/04/2023
Target sample size	2258
Countries of recruitment
Study type	Interventional
Intervention(s)	Group A: Randomized prior to PCI with SYNERGY to non-asupirin (prasugrel alone) for 12 months Group B: Randomized prior to PCI with SYNERGY to dual antiplatelet therapy (aspirin + prasugrel)

TO Original Data: JRCT

Outcome(s)

Primary Outcome	the composite primary cardiovascular endpoint consisting of all-cause death/myocardial infarction/stroke at 12 months after stent implantation
Secondary Outcome	The major secondary endpoint of this study is as follows: 12 months after enrollment Major bleeding (BARC 3 or 5 bleeding) The secondary endpoints of this study are as follows: They will be assessed at 12 months after enrollment. All-cause death Cardiovascular death Non-cardiovascular death MI (target-vessel, non-target vessel) Stroke Ischemic stroke Hemorrhagic stroke ST (ARC) TLF TVF POCE Any TLR Clinically driven TLR Non TLR CABG Any TVR Any coronary revascularization Bleeding complications BARC 2 BARC 3 BARC 4 BARC 5 BARC 2/3/5 TIMI major TIMI minor TIMI major/minor GUSTO severe GUSTO moderate GUSTO moderate/severe Intracranial bleeding Gastrointestinal bleeding Gastrointestinal complaints

Primary Outcome

the composite primary cardiovascular endpoint consisting of all-cause death/myocardial infarction/stroke at 12 months after stent implantation

Secondary Outcome

The major secondary endpoint of this study is as follows: 12 months after enrollment Major bleeding (BARC 3 or 5 bleeding) The secondary endpoints of this study are as follows: They will be assessed at 12 months after enrollment. All-cause death Cardiovascular death Non-cardiovascular death MI (target-vessel, non-target vessel) Stroke Ischemic stroke Hemorrhagic stroke ST (ARC) TLF TVF POCE Any TLR Clinically driven TLR Non TLR CABG Any TVR Any coronary revascularization Bleeding complications BARC 2 BARC 3 BARC 4 BARC 5 BARC 2/3/5 TIMI major TIMI minor TIMI major/minor GUSTO severe GUSTO moderate GUSTO moderate/severe Intracranial bleeding Gastrointestinal bleeding Gastrointestinal complaints

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients scheduled for Primary PCI with everolimus-eluting stent (PtCr-EES, SYNERGY) STEMI patients Patients who can continue dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for 12 months
Exclude criteria	Patients taking anticoagulants Under 18 years old Prognosis less than 1 year Participated in other intervention studies

Related Information

Primary Sponsor	Nakazawa Gaku
Secondary Sponsor	Kouzuma Ken,Morino Yoshihiro
Source(s) of Monetary Support	Boston Scientific Japan K.K.
Secondary ID(s)	NCT05709626,

Contact

Public contact
Name	Kuniaki Takahashi
Address	377-2, Onohigashi, Osakasayama city, Osaka Osaka Japan 589-8511
Telephone	+81-72-366-0221
E-mail	kuniaki.t.0125@gmail.com
Affiliation	Kindai University Hospital
Scientific contact
Name	Gaku Nakazawa
Address	377-2, Onohigashi, Osakasayama city, Osaka Osaka Japan 589-8511
Telephone	+81-72-366-0221
E-mail	gnakazawa@med.kindai.ac.jp
Affiliation	Kindai University Hospital

TO Original Data: JRCT