ACETYLSALICYLIC ACID for Coronary artery disease

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years, informed written consent, at least one major or two minor bleeding risk criteria of Academic Research Consortium (ARC)."}
• {"criterion_text":"- Either of the following: Stabile angina or dyspnea and a coronary narrowing causing myocardial ischemia detected in the angiogram."}
• {"criterion_text":"- In stable patients prior PCI, the evidence of ischemia is needed acquired either by perfusion imaging or by pressure wire measurement (FFR) during coronary angiography unless the coronary stenosis is > 90% in diameter."}
• {"criterion_text":"- ACS (UAP or NSTEMI): symptoms of heart ischemia≥ 20 minutes and ≥ 0,5mm ST-depression or transient ST-elevation or T-wave inversion at least in two adjacent leads and/or a high sensitivity troponin (hs-tnt) rise at least one unit above the 99. percentil or at least 50% rise in hs-tnt between two samples taken 1-3 hours apart."}
• {"criterion_text":"- At least one of the following: ≥1 de novo lesions in native coronary arteries or bypass vein grafts."}
• {"criterion_text":"- Reference diameter of the vessel is 2.0-5.0mm."}
• {"criterion_text":"- Lesion length ≤ 40mm."}
• {"criterion_text":"- Lesion or lesions are suitable for PCI."}

Exclusion criteria

• {"criterion_text":"- Inability to give written consent"}
• {"criterion_text":"- STEMI."}
• {"criterion_text":"- Reference diameter of the vessel is <2.0mm or >5.0 mm."}
• {"criterion_text":"- Bifurcation lesion requiring the stenting of either of the branches after predilatation. (TIMI<3 or significant recoil >30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation)."}
• {"criterion_text":"- Dissection affecting the flow (TIMI<3) or significant recoil (>30% in the main epicardial vessel: LAD, LCX or RCA) after predilatation."}
• {"criterion_text":"- In-stent restenosis."}
• {"criterion_text":"- Chronic total occlusion."}
• {"criterion_text":"- Life expectancy < 12 months."}
• {"criterion_text":"- Cardiogenic shock at the arrival to the coronary angiography."}
• {"criterion_text":"- Uncertainty about neurological recovery e.g. after resuscitation."}
• {"criterion_text":"- Need for bypass surgery by heart team decision."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the composite of MACE and BARC (Bleeding academic research consortium) type 2-5 bleeding episodes at 12 months. Major Adverse Cardiac Event = a composite of cardiac death, nonfatal myocardial infarction (MI) and ischemia driven-target lesion revascularization (ID-TLR)","definition_or_measurement_approach":"Composite measured at 12 months. MACE defined as cardiac death, nonfatal myocardial infarction (MI) and ischemia-driven target lesion revascularization (ID-TLR). Bleeding assessed using BARC (Bleeding Academic Research Consortium) types 2-5."}

Secondary endpoints

• {"endpoint_text":"- The composite of MACE and BARC2-5 bleedings (24 and 36 months)","definition_or_measurement_approach":"Composite measured at 24 and 36 months. MACE as defined for primary; BARC 2-5 bleeding per BARC criteria."}
• {"endpoint_text":"- MACE 12, 24 and 26 months","definition_or_measurement_approach":"MACE measured at 12, 24 and 26 months; defined as cardiac death, nonfatal MI and ischemia-driven TLR."}
• {"endpoint_text":"- BARC2-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"BARC 2-5 bleedings measured at 12, 24 and 26 months using BARC bleeding definitions."}
• {"endpoint_text":"- BARC3-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"BARC 3-5 bleedings measured at 12, 24 and 26 months using BARC bleeding definitions."}
• {"endpoint_text":"- Total mortality 12, 24 and 26 months","definition_or_measurement_approach":"All-cause mortality measured at 12, 24 and 26 months."}
• {"endpoint_text":"- Cardiovascular mortality 12, 24 and 26 months","definition_or_measurement_approach":"Cardiovascular-specific mortality measured at 12, 24 and 26 months."}
• {"endpoint_text":"- Myocardial infarction 12, 24 and 26 months","definition_or_measurement_approach":"Myocardial infarction events measured at 12, 24 and 26 months using study definitions (MI criteria as per protocol)."}
• {"endpoint_text":"- TLR 12, 24 and 26 months","definition_or_measurement_approach":"Target lesion revascularization measured at 12, 24 and 26 months."}
• {"endpoint_text":"- Target-vessel failure (TVF) 12, 24 and 26 months","definition_or_measurement_approach":"Target-vessel failure measured at 12, 24 and 26 months (protocol definition)."}
• {"endpoint_text":"- Target-lesion failure (TLF) 12, 24 and 26 months","definition_or_measurement_approach":"Target-lesion failure measured at 12, 24 and 26 months (protocol definition)."}
• {"endpoint_text":"- The composite of TLR and BARC2-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"Composite of TLR and BARC 2-5 bleedings measured at 12, 24 and 26 months."}
• {"endpoint_text":"- The composite of TVF and BARC2-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"Composite of TVF and BARC 2-5 bleedings measured at 12, 24 and 26 months."}
• {"endpoint_text":"- The composite of TLF and BARC2-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"Composite of TLF and BARC 2-5 bleedings measured at 12, 24 and 26 months."}
• {"endpoint_text":"- The composite of TLR and BARC3-5 bleedings 12, 24 and 26 months","definition_or_measurement_approach":"Composite of TLR and BARC 3-5 bleedings measured at 12, 24 and 26 months."}
• {"endpoint_text":"- Acute vessel closure as defined by the consensus criteria for definite/probable stent thrombosis","definition_or_measurement_approach":"Acute vessel closure assessed per consensus criteria for definite/probable stent thrombosis."}
• {"endpoint_text":"- Hospitalization for urgent revascularization","definition_or_measurement_approach":"Hospital admissions for urgent revascularization tracked during follow-up."}
• {"endpoint_text":"- Stroke (ischemic or hemorrhagic) or TIA 12, 24 and 26 months","definition_or_measurement_approach":"Ischemic or hemorrhagic stroke or TIA events measured at 12, 24 and 26 months."}

Finland

Earliest CTIS Part Ii Submission Date

11-12-2023

Latest Decision Or Authorization Date

11-01-2024

Processing Time Days

31

Number Of Sites

6

Number Of Participants

534

France

Earliest CTIS Part Ii Submission Date

28-07-2024

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

257

Number Of Sites

2

Number Of Participants

100

Spain

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

26-06-2025

Processing Time Days

3

Number Of Sites

2

Number Of Participants

100

Primary sponsor

Full Name

Wellbeing Services County Of North Karelia Siun Sote

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Finland

Third parties

• {"country":"Finland","full_name":"Kuopio University Hospital","duties_or_roles":"6","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"B Braun Melsungen","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Finnish Cardiovascular Foundation","duties_or_roles":"Monetary support","organisation_type":""}