Actively Recruiting
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
Led by Research Maatschap Cardiologen Rotterdam Zuid · Updated on 2025-08-06
1656
Participants Needed
26
Research Sites
314 weeks
Total Duration
On this page
Sponsors
R
Research Maatschap Cardiologen Rotterdam Zuid
Lead Sponsor
A
Abbott Medical Devices
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with ST segment elevation myocardial infarction planned for percutaneous coronary intervention (PCI)
- Chest discomfort suggestive of cardiac ischemia lasting 20 minutes or more at rest with ECG showing ST segment elevation in 2 or more contiguous leads or new/presumed new left bundle branch block
- Treatment of culprit lesion during primary PCI
- Complete revascularization of non-culprit lesions within 15 days for patients with multivessel disease
- Patients who have provided informed consent
- Compliance to dual antiplatelet therapy with no regimen modifications between 30 and 45 days
- No major adverse events such as myocardial infarction, unplanned revascularization, stent thrombosis, stroke, or major bleeding
- Successful device delivery with less than 30% residual stenosis in target lesions
- Physiologic assessment recommended for lesions with 50% to 90% stenosis
You will not qualify if you...
- Use of oral anticoagulation therapy
- Contraindications to P2Y12 inhibitors or Aspirin, including hypersensitivity, recent stroke or transient ischemic attack within 12 months, active bleeding, recent fibrinolytic therapy, severe liver dysfunction, aspirin-induced asthma, severe heart failure (NYHA III or IV), or use of methotrexate at doses of 15 mg/week or more
- Prior use of P2Y12 inhibitors other than Prasugrel without Prasugrel loading dose at admission
- Use of strong CYP3A inhibitors, substrates, or inducers
- Platelet count below 100,000/µL or hemoglobin below 10 g/dL at screening
- Life expectancy less than 1 year due to other illnesses
- Pregnancy, recent childbirth within 90 days, or breastfeeding
- History of stent thrombosis or indication for PCI due to stent thrombosis
- Planned major surgery that cannot be delayed after PCI
- Cardiogenic shock or out-of-hospital cardiac arrest unless ventricular arrhythmia survivors with prompt return of circulation
- Severe kidney impairment with creatinine clearance below 30 ml/min/1.73 m2
- Participation in other interventional trials within 12 months or investigational drug use within 30 days or 5 half-lives of study drug
- Lack of informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Imelda Bonheiden
Bonheiden, Belgium
Actively Recruiting
2
AZ St.Jan
Bruges, Belgium
Actively Recruiting
3
ZOL Genk
Genk, Belgium
Actively Recruiting
4
UZ Leuven
Leuven, Belgium
Not Yet Recruiting
5
AZ Delta
Roeselare, Belgium
Actively Recruiting
6
FN BRNO
Brno, Czechia
Actively Recruiting
7
Masaryk Hospital Usti nad Labem -
Hradec Králové, Czechia
Not Yet Recruiting
8
Charles University Hospital
Prague, Czechia
Not Yet Recruiting
9
Asklepios Klinik Bad Oldesloe
Bad Oldesloe, Germany
Actively Recruiting
10
Segeberger Kliniken
Bad Segeberg, Germany
Actively Recruiting
11
University hospital Dresden
Dresden, Germany
Actively Recruiting
12
Ospedale Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
13
University of Ferrara
Ferrara, Italy
Actively Recruiting
14
University San Martino
Genova, Italy
Actively Recruiting
15
Centro Cardiologico Monzino IRCCS
Milan, Italy
Actively Recruiting
16
University Federico II
Naples, Italy
Actively Recruiting
17
University Gemelli
Roma, Italy
Actively Recruiting
18
Albert Schweitzer ziekenhuis
Dordrecht, Netherlands
Actively Recruiting
19
Catherina ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
20
RadboudUMC
Nijmegen, Netherlands
Actively Recruiting
21
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
22
Maasstadziekenhuis
Rotterdam, Netherlands
Actively Recruiting
23
Haga hospital
The Hague, Netherlands
Actively Recruiting
24
Institute for CVD Dedinje
Belgrade, Serbia
Not Yet Recruiting
25
University clinical center of Serbia
Belgrade, Serbia
Not Yet Recruiting
26
Institute for CVD Vojvodine
Kamenitz, Serbia
Not Yet Recruiting
Research Team
V
Valeria Paradies, MD
CONTACT
R
Ria van Vliet
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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