acetylsalicylic acid for Chronic coronary syndrome | Acute coronary syndrome

Inclusion criteria

• {"criterion_text":"- Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels\n- De novo coronary lesions in vessels with diameter >=2.0 and <=4.0 mm (visual estimation)\n- Stable or unstable coronary syndromes\n- Informed consent to participate in the study given by the patient or impartial witness\n- Male and female patients age ≥ 75 years or at high bleeding risk"}

Exclusion criteria

• {"criterion_text":"- Stent implantation during index or recent (<6 months) procedure\n- Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated\n- History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage\n- Acute gastrointestinal ulcers\n- Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding)\n- Severe renal impairment (eGFR < 30 mL/min)\n- Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST > 2 x ULN or total bilirubin >1.5 x ULN)\n- Severe cardiac failure (NYHA grade III or IV)\n- Combination with methotrexate at doses of 15 mg/week or more\n- Patients with baseline neutrophil counts < 1500 cells/mm³\n- Breastfeeding women\n- Full-blown thyrotoxicosis\n- Patients with a very high risk of thrombosis\n- Pregnancy at the time of hospitalization\n- Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer\n- ST-elevation myocardial infarction\n- Life expectancy <12 months\n- Left ventricular ejection fraction <30%\n- Visible thrombus at lesion site\n- Target lesion/vessel with any of the following characteristics: • severe and/or >270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory); • left main stem stenosis >50%; • target lesion is in the left main stem; • chronic total occlusion with anticipated necessity of retrograde approach; • lesion is in a bypass graft."}

Primary endpoints

• {"endpoint_text":"- Primary endpoint of the study will be the rate of Net Adverse Clinical Events (NACE) at 12 months, defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3, or 5), for which superiority of the SAPT arm over DAPT is hypothesized.","definition_or_measurement_approach":"NACE at 12 months defined as the composite of MACE and clinically relevant bleeding events (Bleeding Academic Research Consortium [BARC] 2, 3, or 5); measured as event rate at 12 months comparing SAPT vs DAPT."}

Secondary endpoints

• {"endpoint_text":"- Procedural success (final % stenosis <30%, distal TIMI 3 flow and absence of inhospital major adverse events); (Expected Rate: 95%)","definition_or_measurement_approach":"Procedural success defined as correct delivery of device with final % stenosis <30%, distal TIMI 3 flow and absence of in-hospital major adverse events; expected rate ~95%."}
• {"endpoint_text":"- Patient-oriented composite endpoint (PoCE), a composite of all-cause death, all MIs, or any repeat revascularization","definition_or_measurement_approach":"Composite endpoint measured as occurrence of any of all-cause death, any myocardial infarction (MI), or any repeat revascularization."}
• {"endpoint_text":"- Cardiovascular and cardiac death (Expected Rate: 1-2%)","definition_or_measurement_approach":"Occurrence of cardiovascular or cardiac death; expected event rate reported."}
• {"endpoint_text":"- All-cause death (Expected Rate: 3-5%)","definition_or_measurement_approach":"Occurrence of death from any cause; expected rate provided."}
• {"endpoint_text":"- Q-wave MI (Expected Rate: 0.5-1%)","definition_or_measurement_approach":"Occurrence of Q-wave myocardial infarction; expected rate provided."}
• {"endpoint_text":"- Any MI (Expected Rate: 3-4%)","definition_or_measurement_approach":"Occurrence of any myocardial infarction (including periprocedural MI diagnosed per Fourth Definition of MI); expected rate provided."}
• {"endpoint_text":"- TLR (Expected Rate: 2-3%)","definition_or_measurement_approach":"Target lesion revascularization occurrence; expected rate provided."}
• {"endpoint_text":"- TVR (Expected Rate: 3-4%)","definition_or_measurement_approach":"Target vessel revascularization occurrence; expected rate provided."}
• {"endpoint_text":"- Acute vessel occlusion (ARC criteria); (Expected Rate: 4-6%)","definition_or_measurement_approach":"Acute vessel occlusion defined per ARC criteria; expected rate provided."}
• {"endpoint_text":"- Transfusion rates (Expected Rate: 1-2%)","definition_or_measurement_approach":"Occurrence/rate of blood transfusions; expected rate provided."}
• {"endpoint_text":"- Functional Status and QoL will be assessed using a validated questionnaire with EQ-5D-5L at baseline, 1 month, 6 months, and 12 months. Rate for QoL/Functional Status: (Improvement: ≥5% increase in score from baseline; Deterioration: ≥5% decrease in score from baseline; No Change: ±5% change from baseline)","definition_or_measurement_approach":"EQ-5D-5L questionnaire administered at baseline, 1, 6, and 12 months; change thresholds defined (≥5% improvement/deterioration)."}
• {"endpoint_text":"- BARC 2, 3, or 5 bleedings (superiority in study group is expected)","definition_or_measurement_approach":"Bleeding events classified by BARC; rate of BARC 2/3/5 bleeding events compared between groups."}

Belgium

Earliest CTIS Part Ii Submission Date

20-06-2025

Latest Decision Or Authorization Date

28-11-2025

Processing Time Days

161

Number Of Sites

2

Number Of Participants

60

Luxembourg

Earliest CTIS Part Ii Submission Date

22-07-2025

Latest Decision Or Authorization Date

01-12-2025

Processing Time Days

132

Number Of Sites

1

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

24-07-2025

Latest Decision Or Authorization Date

27-11-2025

Processing Time Days

126

Number Of Sites

9

Number Of Participants

256

Italy

Earliest CTIS Part Ii Submission Date

15-07-2025

Latest Decision Or Authorization Date

09-12-2025

Processing Time Days

147

Number Of Sites

8

Number Of Participants

230

Primary sponsor

Full Name

Fondazione Ricerca e Innovazione Cardiovascolare

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy

Third parties

• {"country":"Spain","full_name":"iVascular - Barcelona- Spain","duties_or_roles":"Source of monetary support","organisation_type":""}