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

NCT05491200 | Recruiting Phase 4 DMC

• 1 other identifier: RM21
• Study Type: interventional
• Target: 1,656
• Locations: 6 countries
• Sites: 26

Brief 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.

Conditions

ST Elevated Myocardial Infarction; Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  11 months

• 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)

  immediately after the procedure

Secondary Outcomes (2)

• Composite of MACCE

  3 year

• BARC type 3 or 5 events

  1 and 3 years

Study Arms (4)

Prasugrel-based short DAPT

EXPERIMENTAL

Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy for 11 months.

Drug: Prasugrel based short DAPT

Prasugrel based standard DAPT

ACTIVE COMPARATOR

Prasugrel-based DAPT for 1 year

Drug: Prasugrel based standard DAPT

OCT guided non-culprit lesion

EXPERIMENTAL

Complete revascularization of non culprit lesions guided by OCT

Device: OCT guided revascularization

Angio guided non-culprit lesion

ACTIVE COMPARATOR

Complete revascularization of non culprit lesions guided by Angio

Device: Angio guided revascularization

Interventions

Prasugrel based short DAPT DRUG

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

Prasugrel-based short DAPT

Prasugrel based standard DAPT DRUG

Prasugrel based DAPT for 1 year

Prasugrel based standard DAPT

OCT guided revascularization DEVICE

OCT guided revascularization of the non-culprit lesions

OCT guided non-culprit lesion

Angio guided revascularization DEVICE

Angio guided revascularization of the non-culprit lesions

Angio guided non-culprit lesion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify 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 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

Sponsors & Collaborators

• Research Maatschap Cardiologen Rotterdam Zuid: lead
• Abbott Medical Devices: collaborator

Study Sites (26)

Imelda Bonheiden

Bonheiden, Belgium

RECRUITING

AZ St.Jan

Bruges, Belgium

RECRUITING

ZOL Genk

Genk, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

NOT YET RECRUITING

AZ Delta

Roeselare, Belgium

RECRUITING

FN BRNO

Brno, Czechia

RECRUITING

Masaryk Hospital Usti nad Labem -

Hradec Králové, Czechia

NOT YET 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

Napoli, Italy

RECRUITING

University Gemelli

Roma, Italy

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

NOT YET RECRUITING

University clinical center of Serbia

Belgrade, Serbia

NOT YET RECRUITING

Institute for CVD Vojvodine

Kamenitz, Serbia

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 40375771 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Valeria Paradies, MD, PhD

  Research Maatschap Cardiologen Rotterdam Zuid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Paradies, MD

CONTACT

+31621620153; paradiesV2@maasstadziekenhuis.nl

Ria van Vliet

CONTACT

+31644162844; vlietM@maasstadziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 8, 2022
• Study Start: July 22, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (6); SE (3); DE (3); CZ (3); BE (5); IT (6)