D,L-lysine acetylsalicylate for Aortic stenosis

Inclusion criteria

• {"criterion_text":"- •\tAge ≥ 18\n- •\tSuccessful transfemoral TAVI for symptomatic aortic stenosis as defined by VARC-33 o\tSuccessful access, delivery of the device, and retrieval of the delivery system o\tCorrect positioning of a single prosthetic heart valve into the proper anatomical location o\tFreedom from surgery or intervention related to the device (excluding permanent pacemaker) or to a major vascular or access-related, or cardiac structural complication\n- •\tWritten informed consent\n- •\tSocial security affiliated\n- •\tFrench speaking\n- •\tMale or, post-menopausal -with no menses for 12 months without an alternative medical cause- or permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy- female"}

Exclusion criteria

• {"criterion_text":"- •\tUn-successful TAVI defined by the absence of any of the above-mentioned criteria defining successful TAVI\n- •\tWomen of childbearing potential: non menopaused -with no menses for 12 months without an alternative medical cause- and not permanently sterilized -hystercetomy, bilateral salpingectomy or bilateral oophorectomy-\n- •\tAlternative non-femoral-approach TAVI: apical, direct trans-aortic, subclavian, axillary or carotid approaches\n- •\tTAVI for other indications than aortic stenosis (pure aortic regurgitation)\n- •\tValve in valve TAVI\n- •\tAny indication for long term antiplatelet therapy: (e.g. coronary artery disease, cerebrovascular disease, peripheral arterial disease…) at any time prior to randomization\n- •\tAny indication for oral anticoagulation: (e.g. atrial fibrillation, deep vein thrombosis, pulmonary embolism, ventricular thrombus…) at any time prior to randomization\n- •\tPatients on long term antiplatelet or anticoagulant therapy prior to TAVI for any other indication than TAVI\n- •\tAny contraindication to long term antiplatelet therapy (e.g. allergy or intolerance to aspirin, major bleeding, high bleeding risk, thrombocytopenia < 50 000, major haemostasis disorder…)\n- •\tAdult with protective measures (tutorship, curatorship)"}

Primary endpoints

• {"endpoint_text":"- Net clinical benefit defined by the composite of all cause death, type 1 myocardial infarction, NeuroARC types 1a, 1aH, 1b, 1c, 1d ischemic or hemorrhagic central nervous system (CNS) injury and non-procedure-related major or disabling bleeding VARC types 2 or 3 12 months after successful TAVI","definition_or_measurement_approach":"Composite clinical event at 12 months after successful TAVI (all-cause death, type 1 MI, specified NeuroARC CNS injuries, non-procedure-related major/disabling bleeding VARC types 2 or 3). Outcomes adjudicated by an independent blinded adjudication committee."}

Secondary endpoints

• {"endpoint_text":"- •\tAny non-procedure-related bleeding defined by the VARC classification 1 to 4","definition_or_measurement_approach":"Bleeding events classified and measured according to VARC classification types 1–4."}
• {"endpoint_text":"- •\tMajor or disabling or life threatening bleeding defined by VARC classification 2 or 3","definition_or_measurement_approach":"Major/disabling/life-threatening bleeding events defined per VARC classification types 2 or 3."}
• {"endpoint_text":"- •\tMajor cardiovascular events defined by the composite of all cause death, myocardial infarction based on the universal definition or stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury","definition_or_measurement_approach":"Composite of all-cause death, MI (universal definition), or stroke (NeuroARC types 1a or 1d ischemic CNS injury)."}
• {"endpoint_text":"- •\tType 1 VARC classification bleeding","definition_or_measurement_approach":"Bleeding events meeting VARC type 1 criteria."}
• {"endpoint_text":"- •\tType 2 VARC classification bleeding","definition_or_measurement_approach":"Bleeding events meeting VARC type 2 criteria."}
• {"endpoint_text":"- •\tType 3 VARC classification bleeding","definition_or_measurement_approach":"Bleeding events meeting VARC type 3 criteria."}
• {"endpoint_text":"- •\tFatal bleeding defined by Type 4 VARC classification","definition_or_measurement_approach":"Fatal bleeding events defined by VARC type 4."}
• {"endpoint_text":"- •\tDeath","definition_or_measurement_approach":"All-cause mortality assessed during follow-up."}
• {"endpoint_text":"- •\tCardiovascular death","definition_or_measurement_approach":"Deaths attributable to cardiovascular causes."}
• {"endpoint_text":"- •\tType 1 myocardial infarction based on the universal definition","definition_or_measurement_approach":"Type 1 MI adjudicated per the universal MI definition."}
• {"endpoint_text":"- •\tStroke defined by NeuroARC types 1a, or 1d ischemic CNS injury","definition_or_measurement_approach":"Stroke events classified according to NeuroARC types 1a or 1d."}
• {"endpoint_text":"- •\tIntracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury","definition_or_measurement_approach":"Intracranial hemorrhagic CNS injuries per NeuroARC types 1aH, 1b, 1c."}
• {"endpoint_text":"- •\tTransient cerebral ischemic attack defined by NeuroARC type 3a","definition_or_measurement_approach":"Transient ischemic attacks classified as NeuroARC type 3a."}
• {"endpoint_text":"- •\tAny hospitalization","definition_or_measurement_approach":"All-cause hospital admissions during follow-up."}
• {"endpoint_text":"- •\tCardiovascular hospitalization","definition_or_measurement_approach":"Hospital admissions for cardiovascular reasons."}
• {"endpoint_text":"- •\tVARC-defined prosthetic valve thrombosis","definition_or_measurement_approach":"Prosthetic valve thrombosis assessed per VARC definitions."}
• {"endpoint_text":"- •\tVARC-3 defined Cardiovascular hospitalization","definition_or_measurement_approach":"Cardiovascular hospitalizations defined according to VARC-3 criteria."}
• {"endpoint_text":"- •\tDeath at 2 years (national mortality database)","definition_or_measurement_approach":"All-cause mortality at 2 years assessed via linkage to the national mortality database."}

Methods

• Sites will enroll patients after successful transfemoral TAVI; the trial is nested in an ongoing nation-wide TAVI registry and recruitment occurs at participating hospital cardiology centers in France.

France

Earliest CTIS Part Ii Submission Date

25-01-2024

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

813

Number Of Sites

20

Number Of Participants

1400

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Caen Normandie

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS (PHRC National)","duties_or_roles":"Monetary support","organisation_type":""}