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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Research Maatschap Cardiologen Rotterdam Zuid

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

1 Aug 2024 → ongoing

Decision date (initial)

2025-02-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Abbott Vascular

External identifiers

EU CT number

2024-515883-30-00

EudraCT number

2021-005499-20

ClinicalTrials.gov

NCT05491200

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Demonstrate the non inferiority of a Prasugrel-based short DAPT (30-45 days) followed by Prasugrel monotherapy versus standard DAPT regimen
by assessing: Incidence of NACE as assessed 11 month after randomization (12 months after primary PCI or revascularization completion by staged PCI)
The co-primary objective is to demonstrate in patients with multivessel disease the superiority of an Optical Coherence Tomography (OCT)-
guided revascularization completion following primary PCI as compared to a standard angiography-guided revascularization completion in terms
of post-procedural Minimal Stent Area (MSA)

Conditions and MedDRA coding

St-Elevated Myocardial Infartion

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 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.
2. 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; see section 6.4.4)  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, 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 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. - Net Adverse Clinical Events (NACE) Composite endpoint of cardiovascular deaths, myocardial infarction, stroke or bleeding BARC 3 or 5 at 11 months post DAPT randomization.
2. - Post-procedural Minimal Stent Area (MSA) Final Post-PCI MSA assessed by OCT in each randomized arm, measured at an independent OCT core laboratory blinded to imaging modality assignment.

Secondary endpoints 5

1. Major Adverse Cerebrovascular Events (MACE) Composite endpoint of deaths, myocardial infarction or stroke at 2, 11 and 35 months
2. BARC type 3 or 5 at 2,11 and 35 months
3. Incidence of target vessel failure (TVF), the composite time-to-first event rate of death, target vessel myocardial infarction (TV-MI) (per-protocol MI definition), or ischemia-driven target vessel revascularization (ID-TVR) at 2, 11 and 35 months
4. Procedural outcomes OCT-defined (OCT core laboratory assessed). Subjects in the angiography-guided arm will undergo a post-PCI OCT run. Assessed per target lesion. 1. Stent expansion; 2. Mean stent expansion; 3. Edge dissection; 4.Stent Malapposition; 5.Border detection; 6.Untreated reference segmet disease
5. - Incidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Research Maatschap Cardiologen Rotterdam Zuid

Sponsor organisation

Research Maatschap Cardiologen Rotterdam Zuid

Address

Maasstadweg 21

City

Rotterdam

Postcode

3079 DZ

Country

Netherlands

Scientific contact point

Organisation

Research Maatschap Cardiologen Rotterdam Zuid

Contact name

Valeria Paradies

Public contact point

Organisation

Research Maatschap Cardiologen Rotterdam Zuid

Contact name

Valeria Paradies

Locations

5 EU/EEA countries · 25 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

11 submissions — initial application plus substantial / non-substantial modifications