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AzTrials

ST Elevated Myocardial InfarctionPhase 4NCT05491200

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

A Phase 4 study testing Prasugrel based short DAPT, Prasugrel based standard DAPT and OCT guided revascularization in people with ST Elevated Myocardial Infarction and Dual Antiplatelet Therapy, run by Research Maatschap Cardiologen Rotterdam Zuid at 27 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Prasugrel based short DAPT, Prasugrel based standard DAPT and OCT guided revascularization
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,656 participants
Where
27 sitesin 6 countries
Study dates
22 Jul 2022to 1 Aug 2029
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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%.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

27 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Valeria Paradies, MD contact

+31621620153

paradiesV2@maasstadziekenhuis.nl

Ria van Vliet contact

+31644162844

vlietM@maasstadziekenhuis.nl

27 sites in 6 countries

Netherlands7 sites, 7 recruiting

  • Amphia Ziekenhuis

    Breda, 4818 CK

    Rohit Oemrawsingh, PhD, +31765954092, Oemrawsingh@amphia.nl

    Rohit Oemrawsingh, PhD

    Recruiting

  • Albert Schweitzer ziekenhuis

    Dordrecht

    J.M. Cheng, PhD

    J.M. Cheng

    Recruiting

  • Catherina ziekenhuis

    Eindhoven

    Koen Teeuwen, MD, PhD, 0402399111, koen.teeuwen@catharinaziekenhuis.nl

    MD, Phd, Koen, koen.teeuwen@catharinaziekenhuis.nl

    Recruiting

  • RadboudUMC

    Nijmegen

    Niels v Royen

    Niels v Royen, PhD

    Recruiting

  • Erasmus Medical Center

    Rotterdam

    Nicolas van Mieghem, PHD

    Nicolas v Mieghem

    Recruiting

  • Maasstadziekenhuis

    Rotterdam

    Valeria Paradies, +31621620153, paradiesV2@maasstadziekenhuis.nl

    Valeria Paradies

    Recruiting

  • Haga hospital

    The Hague

    Samer Somi, PhD

    Samer Somi, PhD

    Recruiting

Other trials in Netherlands

Italy6 sites, 6 recruiting

  • Ospedale Papa Giovanni XXIII

    Bergamo

    Paolo Angelo Canova, MD, PhD, pacanova@asst-pg23.it

    Paolo Angelo Canova, MD, PhD

    Recruiting

  • University of Ferrara

    Ferrara

    Gianluca Campo, PhD

    Gianluca Campo, PhD

    Recruiting

  • University San Martino

    Genova

    I. Porto, PhD

    I. Porto, PhD

    Recruiting

  • Centro Cardiologico Monzino IRCCS

    Milan

    Daniela Trabattoni, MD, PhD, daniela.trabattoni@cardiologicomonzino.it

    Daniela Trabattoni, MD, PhD

    Recruiting

  • University Federico II

    Naples

    G. Esposito, PhD

    G. Esposito, PhD

    Recruiting

  • University Gemelli

    Roma

    F. Burzotta, PhD

    F. Burzotta, PhD

    Recruiting

Other trials in Italy

Belgium5 sites, 5 recruiting

  • Imelda Bonheiden

    Bonheiden

    Willem de Wilde, PhD

    Willem de Wilde, PhD

    Recruiting

  • AZ St.Jan

    Bruges

    Patrick Coussement, PhD

    Patrick Coussement, PhD

    Recruiting

  • ZOL Genk

    Genk

    Koen Amelot, PhD

    Koen Amelot, PhD

    Recruiting

  • UZ Leuven

    Leuven

    Tom Adreiaansen, PhD

    Tom Adreiaansen, PhD

    Recruiting

  • AZ Delta

    Roeselare

    Maarten v Haverbeke

    Maarten v Haverbeke, PhD

    Recruiting

Other trials in Belgium

Czechia3 sites, 3 recruiting

  • FN BRNO

    Brno

    Petr Kala, PhD

    Petr Kala, PhD

    Recruiting

  • Masaryk Hospital Usti nad Labem -

    Hradec Králové

    Pavel Cervinka, PhD

    Pavel Cervinka, PhD

    Recruiting

  • Charles University Hospital

    Prague

    Tomas Kovarnik, PhD

    Tomas Kovarnik, PhD

    Not yet recruiting

Other trials in Czechia

Germany3 sites, 3 recruiting

  • Asklepios Klinik Bad Oldesloe

    Bad Oldesloe

    Ralph Tölg, PhD

    Ralph Tölg, PhD

    Recruiting

  • Segeberger Kliniken

    Bad Segeberg

    Arief Kurniadi, PhD

    Arief Kurniadi, PhD

    Recruiting

  • University hospital Dresden

    Dresden

    Axel Linke, PhD

    Axel Linke

    Recruiting

Other trials in Germany

Serbia3 sites, 3 recruiting

  • Institute for CVD Dedinje

    Belgrade

    Mihajlo Farkić, PhD

    Mihajlo Farkić, PhD

    Recruiting

  • University clinical center of Serbia

    Belgrade

    Dejan Milasinovic, PhD

    Dejan Milasinovic, PhD

    Recruiting

  • Institute for CVD Vojvodine

    Kamenitz

    Milovan Petrovic, PhD

    Milovan Petrovic, PhD

    Recruiting

Other trials in Serbia

About this study

Official title: 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.

Read the 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.

Being tested
Prasugrel based short DAPT, Prasugrel based standard DAPT, OCT guided revascularization, Angio guided revascularization
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prasugrel based short DAPTDrug

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

  • Prasugrel based standard DAPTDrug

    Prasugrel based DAPT for 1 year

  • OCT guided revascularizationDevice

    OCT guided revascularization of the non-culprit lesions

  • Angio guided revascularizationDevice

    Angio guided revascularization of the non-culprit lesions

Study groups in NCT05491200
Study groupRoleWhat they receive
Prasugrel-based short DAPTExperimentalPrasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.
Receives: Drug: Prasugrel based short DAPT
Prasugrel based standard DAPTActive comparatorPrasugrel-based DAPT for 1 year
Receives: Drug: Prasugrel based standard DAPT
OCT guided non-culprit lesionExperimentalComplete revascularization of non culprit lesions guided by OCT
Receives: Device: OCT guided revascularization
Angio guided non-culprit lesionActive comparatorComplete revascularization of non culprit lesions guided by Angio
Receives: Device: Angio guided revascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 11 months

  2. 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)

    Measured: immediately after the procedure

Secondary outcomes (2)

  1. Composite of MACCE

    Composite of the number of major adverse cardiac and cerebrovascular events (MACCE) defined as cardiovascular death, myocardial infarction, or ischaemic stroke

    Measured: 3 year

  2. BARC type 3 or 5 events

    Number of BARC type 3 or 5 events occuring

    Measured: 1 and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start22 Jul 2022
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,656 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491200
Sponsor's protocol ID
RM21
Status last verified
Jun 2026
First submitted
2 Aug 2022
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Paradies V, Van Mieghem NM, Oemrawsingh RM, Richardt G, Esposito G, Campo G, Burzotta F, Canova P, Linke A, Porto I, Trabattoni D, Teeuwen K, Adriaenssens T, Kala P, Stankovic G, Vliet RV, Giacoppo D, Daemen J, Smits PC. Prasugrel monotherapy versus standard DAPT in STEMI patients with OCT-guided or angio-guided complete revascularisation: design and rationale of the randomised, multifactorial COMPARE STEMI ONE trial. EuroIntervention. 2025 May 16;21(10):571-580. doi: 10.4244/EIJ-D-24-00829.

    PubMed 40375771

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prasugrel based short DAPT, Prasugrel based standard DAPT and OCT guided revascularization in people with ST Elevated Myocardial Infarction and Dual Antiplatelet Therapy, run by Research Maatschap Cardiologen Rotterdam Zuid at 27 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Netherlands, Italy, Belgium, Czechia, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valeria Paradies, MD (+31621620153, paradiesV2@maasstadziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05491200, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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