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

August 5, 2025 updated by: Research Maatschap Cardiologen Rotterdam Zuid

COMPARE STEMI ONE- Comparison Of Reduced DAPT Followed by P2Y12 Inhibitor Monotherapy With Prasugrel vs stAndard Regimen in STEMI Patients Treated With OCT-guided vs aNgio-guided completE Revascularization

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

1656

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Bonheiden, Belgium
        • Recruiting
        • Imelda Bonheiden
        • Contact:
          • Willem de Wilde, PhD
        • Principal Investigator:
          • Willem de Wilde, PhD
      • Brugge, Belgium
        • Recruiting
        • AZ St.Jan
        • Contact:
          • Patrick Coussement, PhD
        • Principal Investigator:
          • Patrick Coussement, PhD
      • Genk, Belgium
        • Recruiting
        • ZOL GENK
        • Contact:
          • Koen Amelot, PhD
        • Principal Investigator:
          • Koen Amelot, PhD
      • Leuven, Belgium
        • Not yet recruiting
        • UZ Leuven
        • Contact:
          • Tom Adreiaansen, PhD
        • Principal Investigator:
          • Tom Adreiaansen, PhD
      • Roeselare, Belgium
        • Recruiting
        • AZ Delta
        • Contact:
          • Maarten v Haverbeke
        • Principal Investigator:
          • Maarten v Haverbeke, PhD
  • Czechia
      • Brno, Czechia
        • Recruiting
        • FN BRNO
        • Contact:
          • Petr Kala, PhD
        • Principal Investigator:
          • Petr Kala, PhD
      • Hradec Kralove, Czechia
        • Not yet recruiting
        • Masaryk Hospital Usti nad Labem -
        • Contact:
          • Pavel Cervinka, PhD
        • Principal Investigator:
          • Pavel Cervinka, PhD
      • Prague, Czechia
        • Not yet recruiting
        • Charles University Hospital
        • Contact:
          • Tomas Kovarnik, PhD
        • Principal Investigator:
          • Tomas Kovarnik, PhD
  • Germany
      • Bad Oldesloe, Germany
        • Recruiting
        • Asklepios Klinik Bad Oldesloe
        • Contact:
          • Ralph Tölg, PhD
        • Principal Investigator:
          • Ralph Tölg, PhD
      • Bad Segeberg, Germany
        • Recruiting
        • Segeberger Kliniken
        • Contact:
          • Arief Kurniadi, PhD
        • Principal Investigator:
          • Arief Kurniadi, PhD
      • Dresden, Germany
        • Recruiting
        • University Hospital Dresden
        • Principal Investigator:
          • Axel Linke
        • Contact:
          • Axel Linke, PhD
  • Italy
      • Bergamo, Italy
        • Recruiting
        • Ospedale Papa Giovanni XXIII
        • Contact:
        • Principal Investigator:
          • Paolo Angelo Canova, MD, PhD
      • Ferrara, Italy
        • Recruiting
        • University of Ferrara
        • Contact:
          • Gianluca Campo, PhD
        • Principal Investigator:
          • Gianluca Campo, PhD
      • Genova, Italy
        • Recruiting
        • University San Martino
        • Contact:
          • I. Porto, PhD
        • Principal Investigator:
          • I. Porto, PhD
      • Milano, Italy
      • Napoli, Italy
        • Recruiting
        • University Federico II
        • Contact:
          • G. Esposito, PhD
        • Principal Investigator:
          • G. Esposito, PhD
      • Roma, Italy
        • Recruiting
        • University Gemelli
        • Contact:
          • F. Burzotta, PhD
        • Principal Investigator:
          • F. Burzotta, PhD
  • Netherlands
      • Den Haag, Netherlands
        • Recruiting
        • Haga hospital
        • Contact:
          • Samer Somi, PhD
        • Principal Investigator:
          • Samer Somi, PhD
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweitzer Ziekenhuis
        • Principal Investigator:
          • Rohit Oemrawsingh
        • Contact:
          • Rohit Oemrawsingh, PhD
      • Eindhoven, Netherlands
      • Nijmegen, Netherlands
        • Recruiting
        • Radboudumc
        • Contact:
          • Niels v Royen
        • Principal Investigator:
          • Niels v Royen, PhD
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Contact:
          • Nicolas van Mieghem, PHD
        • Principal Investigator:
          • Nicolas v Mieghem
      • Rotterdam, Netherlands
        • Recruiting
        • Maasstadziekenhuis
        • Principal Investigator:
          • Valeria Paradies
        • Contact:
  • Serbia
      • Belgrade, Serbia
        • Not yet recruiting
        • University Clinical Center of Serbia
        • Contact:
          • Dejan Milasinovic, PhD
        • Principal Investigator:
          • Dejan Milasinovic, PhD
      • Belgrade, Serbia
        • Not yet recruiting
        • Institute for CVD Dedinje
        • Contact:
          • Mihajlo Farkić, PhD
        • Principal Investigator:
          • Mihajlo Farkić, PhD
      • Sremska Kamenica, Serbia
        • Not yet recruiting
        • Institute for CVD Vojvodine
        • Contact:
          • Milovan Petrovic, PhD
        • Principal Investigator:
          • Milovan Petrovic, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prasugrel-based short DAPT
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.
Drug: Prasugrel based short DAPT
Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus
Active Comparator: Prasugrel based standard DAPT
Prasugrel-based DAPT for 1 year
Drug: Prasugrel based standard DAPT
Prasugrel based DAPT for 1 year
Experimental: OCT guided non-culprit lesion
Complete revascularization of non culprit lesions guided by OCT
Device: OCT guided revascularization
OCT guided revascularization of the non-culprit lesions
Active Comparator: Angio guided non-culprit lesion
Complete revascularization of non culprit lesions guided by Angio
Device: Angio guided revascularization
Angio guided revascularization of the non-culprit lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel 11 month monotherapy versus standard 12 month DAPT regimen
Time Frame: 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
11 months
superiority of an Optical Coherence Tomography (OCT)-guided revascularization completion as compared to a standard angiography-guided revascularization completion.
Time Frame: immediately after the procedure
Post-procedural Minimal Stent Area (MSA)
immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of MACCE
Time Frame: 3 year
Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke
3 year
BARC type 3 or 5 events
Time Frame: 1 and 3 years
Number of BARC type 3 or 5 events occuring
1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Maatschap Cardiologen Rotterdam Zuid

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Valeria Paradies, MD, PhD, Research Maatschap Cardiologen Rotterdam Zuid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 5, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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