The study is a multi-centre, Open-label, Randomized Controlled, 1:1 trial comparing Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen in STEMI patients in terms of safety and efficacy endpoints. In the subgroup of STEMI patients with MVD, a sub-randomization will allow a comparison between a complete revascularization OCT-guided versus complete revascularization angiography-guided stent in terms of efficacy and safety endpoints.
Consecutive patients with STEMI planned for pPCI will be screened for eligibility criteria and treated as per standard of care with ASA and Prasugrel 60 mg loading dose. The culprit lesion will be treated during the index procedure. Non culprit lesions in patients with MVD will be treated during staged procedure(s), in any case last instalment of staged procedure(s) should be scheduled within 15 days after index procedure. Complete revascularization of non culprit lesions will be allocated to either OCT- or angio-guided strategy (OCT randomization). At 30-45 days follow-up after index procedure, if inclusion criteria are met, patients will be randomized to prasugrel monotherapy or standard DAPT regimen (DAPT randomization). The follow-up duration is 35 months after DAPT randomization, i.e. clinical outcomes will be analysed at 11 and 35 months after DAPT randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,656
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus
Prasugrel based DAPT for 1 year
OCT guided revascularization of the non-culprit lesions
Angio guided revascularization of the non-culprit lesions
Imelda Bonheiden
Bonheiden, Belgium
RECRUITINGAZ St.Jan
Bruges, Belgium
RECRUITINGZOL Genk
Genk, Belgium
RECRUITINGUZ Leuven
Leuven, Belgium
NOT_YET_RECRUITINGAZ Delta
Roeselare, Belgium
RECRUITINGFN BRNO
Brno, Czechia
RECRUITINGMasaryk Hospital Usti nad Labem -
Hradec Králové, Czechia
NOT_YET_RECRUITINGCharles University Hospital
Prague, Czechia
NOT_YET_RECRUITINGAsklepios Klinik Bad Oldesloe
Bad Oldesloe, Germany
RECRUITINGSegeberger Kliniken
Bad Segeberg, Germany
RECRUITING...and 16 more locations
non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen
Incidence of Net Adverse Clinical Events (NACE) at 11 months post DAPT randomization as composite of all cause death, MI, stroke or BARC bleeding 3 or 5
Time frame: 11 months
superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.
Post-procedural Minimal Stent Area (MSA)
Time frame: immediately after the procedure
Composite of MACCE
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
Time frame: 3 year
BARC type 3 or 5 events
Number of BARC type 3 or 5 events occuring
Time frame: 1 and 3 years
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