Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Phase 4

Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients

NCT05491200 · tracked via the Priya Life Science Italy tracker
Sponsor
Research Maatschap Cardiologen Rotterdam Zuid
Phase
Phase 4
Started
2022-07-22
Last updated
2026-07-02

Condition(s) studied

ST Elevated Myocardial InfarctionDual Antiplatelet Therapy

Investigational drug(s) / intervention(s)

Prasugrel based short DAPTPrasugrel based standard DAPTOCT guided revascularizationAngio guided revascularization

Prasugrel based short DAPT: Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus

Prasugrel based standard DAPT: Prasugrel based DAPT for 1 year

OCT guided revascularization: OCT guided revascularization of the non-culprit lesions

Angio guided revascularization: Angio guided revascularization of the non-culprit lesions

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: Eligibility at index procedure All STEMI patients who are planned to be treated with PCI: ST segment elevation myocardial infarction Chest discomfort suggestive of cardiac ischemia ≥20 min at rest with 1 of the following ECG features: * ST segment elevation ≥2 contiguous ECG leads * new or presumably new left bundle branch block In patients with multivessel disease, treatment only of the culprit lesion / target vessel during primary PCI is recommended. Eligibility at 30-45 days * All patients who have provided informed consent * Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0) * No occurrence of significant event (such as MI, unplanned revascularisation, stent thrombosis, stroke, major vascular complication/bleeding BARC Types 3 or greater). * Successful revascularization: - Successful delivery and deployment of the Study device(s), with final residual stenosis of \<30% (visually) for all target lesions. * Complete revascularization performed when more than 1 significant lesion, during the index procedure or in staged procedure(s) occurring within 15 days from the index procedure. Physiologic assessment highly recommended for lesions with stenosis between 50% and 90%. Exclusion criteria * 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 * Platelet count \<100.000/μL at the time of screening * Anemia (hemoglobin \<10 g/dL) at the time of screening * Comorbidities associated with life expectancy \<1 year * Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential) * PCI indication for stent thrombosis or previous history of definite stent thrombosis * Non-deferrable major surgery on DAPT after PCI * Cardiogenic shock * Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC) * Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR). * Patients participating in another interventional (device of drug trial) within the previous 12 months or patients to whom an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer. * No informed consent

Primary outcome measure(s)

  • non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen — 11 months
    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. — immediately after the procedure
    Post-procedural Minimal Stent Area (MSA)

Trial sites (27)

FacilityCityRegionStatus
Imelda Bonheiden Bonheiden Belgium Recruiting
AZ St.Jan Bruges Belgium Recruiting
ZOL Genk Genk Belgium Recruiting
UZ Leuven Leuven Belgium Recruiting
AZ Delta Roeselare Belgium Recruiting
FN BRNO Brno Czechia Recruiting
Masaryk Hospital Usti nad Labem - Hradec Králové Czechia Recruiting
Charles University Hospital Prague Czechia Not Yet Recruiting
Asklepios Klinik Bad Oldesloe Bad Oldesloe Germany Recruiting
Segeberger Kliniken Bad Segeberg Germany Recruiting
University hospital Dresden Dresden Germany Recruiting
Ospedale Papa Giovanni XXIII Bergamo Italy Recruiting
University of Ferrara Ferrara Italy Recruiting
University San Martino Genova Italy Recruiting
Centro Cardiologico Monzino IRCCS Milan Italy Recruiting
University Federico II Naples Italy Recruiting
University Gemelli Roma Italy Recruiting
Amphia Ziekenhuis Breda Netherlands Recruiting
Albert Schweitzer ziekenhuis Dordrecht Netherlands Recruiting
Catherina ziekenhuis Eindhoven Netherlands Recruiting
RadboudUMC Nijmegen Netherlands Recruiting
Erasmus Medical Center Rotterdam Netherlands Recruiting
Maasstadziekenhuis Rotterdam Netherlands Recruiting
Haga hospital The Hague Netherlands Recruiting
Institute for CVD Dedinje Belgrade Serbia Recruiting
University clinical center of Serbia Belgrade Serbia Recruiting
Institute for CVD Vojvodine Kamenitz Serbia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05491200 on ClinicalTrials.gov ↗ ← All trials in Italy