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Compares treatment options for ST Elevated Myocardial Infarction
Official title Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients
ClinicalTrials.gov ID: NCT05491200
What this study is testing
What is Prasugrel based short DAPT?
Prasugrel based short DAPT is an investigational medicine, being studied as a potential treatment for st elevated myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Eligibility at index procedure All STEMI patients who are planned to be treated with PCI: ST segment elevation myocardial infarction Chest discomfort...
- 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...
- All patients who have provided informed consent
- Compliance to DAPT with no regimen modifications (Non-adherence Academic Research Consortium 0)
You likely can't join if
- 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...
- Patients who have received P2Y12 inhibitors other than Prasugrel in the ambulance (Ticagrelor or Clopidogrel loading dose) or are already on P2Y12...
- Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin...
- Platelet count \<100.000/μL at the time of screening
- Anemia (hemoglobin \<10 g/dL) at the time of screening
See the full eligibility 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...
- 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...
- 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...
- 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...
- Concomitant oral or i.v. therapy with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir...
- 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 treatment (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...
- No informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Bonheiden, Belgium
- Bruges, Belgium
- Genk, Belgium
- Leuven, Belgium
- Roeselare, Belgium
- Brno, Czechia
- Hradec Králové, Czechia
- Prague, Czechia
- Bad Oldesloe, Germany
- Bad Segeberg, Germany
- Dresden, Germany
- Bergamo, Italy
- Ferrara, Italy
- Genova, Italy
- Milan, Italy
- Naples, Italy
- Roma, Italy
- Breda, Netherlands
- Dordrecht, Netherlands
- Eindhoven, Netherlands
+ 5 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonheiden, Belgium; Bruges, Belgium; Genk, Belgium; Leuven, Belgium; Roeselare, Belgium; Brno, Czechia and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.