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.
ST segment elevation ≥2 contiguous ECG leads
new or presumably new left bundle branch block
All patients who have provided informed consent
Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
Patients on oral anticoagulation
Contraindication to P2Y12 inhibitors and/or to Cardioaspirin or to any of the excipients (hypersensitivity, history of any stroke or transient ischemic attack within the last 12 months, active bleeding or haemorrhagic diathesis, fibrin-specific fibrinolytic therapy less than 24 h before randomization, severe hepatic dysfunction (Child-Pugh C), history of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines, history of gastrointestinal perforation or acute gastrointestinal ulcers, severe cardiac failure (NYHA grade III or IV), combination with methotrexate at doses of 15 mg/week or more).
Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12 inhibitors, may be enrolled in the protocol, provided that the Prasugrel loading dose is administered at admission, according to current guidelines recommendations (see section 5.2.2).
Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice >1L/day), CYP3A substrates with narrow therapeutic indices (e.g., cyclosporine, quinidine), or strong CYP3A inducers (e.g., rifampin), - rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital
Parallel
Prasugrel based short DAPT
DrugPrasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus
Prasugrel based standard DAPT
DrugPrasugrel based DAPT for 1 year
OCT guided revascularization
DeviceOCT guided revascularization of the non-culprit lesions
Angio guided revascularization
DeviceAngio guided revascularization of the non-culprit lesions
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
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)
Composite of MACCE
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
BARC type 3 or 5 events
Number of BARC type 3 or 5 events occuring
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Research Maatschap Cardiologen Rotterdam Zuid
Lead sponsor
Abbott Medical Devices
Collaborator
