ACETYLSALICYLIC ACID for ST-elevation myocardial infarction

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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

• {"criterion_text":"- Patients on oral anticoagulation"}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital"}
• {"criterion_text":"- Platelet count <100.000/μL at the time of screening"}
• {"criterion_text":"- Anemia (hemoglobin <10 g/dL) at the time of screening"}
• {"criterion_text":"- Comorbidities associated with life expectancy <1 year"}
• {"criterion_text":"- Pregnancy, giving birth within the last 90 days, or lactation (see appendix III for women of childbearing potential)"}
• {"criterion_text":"- PCI indication for stent thrombosis or previous history of definite stent thrombosis"}
• {"criterion_text":"- Non-deferrable major surgery on DAPT after PCI"}
• {"criterion_text":"- Cardiogenic shock"}
• {"criterion_text":"- Out of hospital cardiac arrest (OHCA) unless survivors of ventricular arrythmia with prompt return of spontaneous circulation (ROSC)"}
• {"criterion_text":"- Patients with severe renal impairment: creatinine clearance ≤30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- No informed consent"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite endpoint of cardiovascular deaths, myocardial infarction, stroke or BARC 3 or 5 bleeding assessed at 11 months after DAPT randomization."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Final post-PCI Minimal Stent Area (MSA) measured by Optical Coherence Tomography (OCT) at an independent OCT core laboratory blinded to imaging modality assignment."}

Secondary endpoints

• {"endpoint_text":"Major Adverse Cerebrovascular Events (MACE) Composite endpoint of deaths, myocardial infarction or stroke at 2, 11 and 35 months","definition_or_measurement_approach":"Composite of death, myocardial infarction or stroke assessed at 2, 11 and 35 months."}
• {"endpoint_text":"BARC type 3 or 5 at 2,11 and 35 months","definition_or_measurement_approach":"Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding events assessed at 2, 11 and 35 months."}
• {"endpoint_text":"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","definition_or_measurement_approach":"Time-to-first-event composite of death, target-vessel MI (per-protocol definition) or ischemia-driven target vessel revascularization assessed at 2, 11 and 35 months."}
• {"endpoint_text":"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","definition_or_measurement_approach":"OCT-defined procedural outcomes assessed per target lesion by an OCT core laboratory (stent expansion, mean stent expansion, edge dissection, malapposition, border detection, untreated reference segment disease)."}
• {"endpoint_text":"-\tIncidence of stent thrombosis (definite or probable as defined by the Academic Research Consortium","definition_or_measurement_approach":"Incidence of definite or probable stent thrombosis as defined by the Academic Research Consortium."}

Belgium

Earliest CTIS Part Ii Submission Date

31-01-2025

Latest Decision Or Authorization Date

14-02-2025

Processing Time Days

14

Number Of Sites

5

Number Of Participants

300

Czechia

Earliest CTIS Part Ii Submission Date

05-12-2024

Latest Decision Or Authorization Date

11-03-2025

Processing Time Days

96

Number Of Sites

3

Number Of Participants

100

Germany

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

25-07-2024

Processing Time Days

15

Number Of Sites

3

Number Of Participants

100

Italy

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

29-07-2024

Processing Time Days

19

Number Of Sites

8

Number Of Participants

400

Netherlands

Earliest CTIS Part Ii Submission Date

10-07-2024

Latest Decision Or Authorization Date

20-07-2024

Processing Time Days

10

Number Of Sites

7

Number Of Participants

700

Primary sponsor

Full Name

Research Maatschap Cardiologen Rotterdam Zuid

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Netherlands