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Short versus long antiplatelet therapy after TAVI

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508208-40-00
Enrollment
1400
Registered
2024-03-22
Start date
2024-11-21
Completion date
Unknown
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All adult patients with successful transfemoral trans-aortic valve implantation (TAVI ) for symptomatic aortic stenosis (AS) with no other indication for long term antiplatelet or anticoagulant therapy

Brief summary

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

Detailed description

• Any non-procedure-related bleeding defined by the VARC classification 1 to 4, • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3, • Major 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, • Type 1 VARC classification bleeding, • Type 2 VARC classification bleeding, • Type 3 VARC classification bleeding, • Fatal bleeding defined by Type 4 VARC classification, • Death, • Cardiovascular death, • Type 1 myocardial infarction based on the universal definition, • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury, • Transient cerebral ischemic attack defined by NeuroARC type 3a, • Any hospitalization, • Cardiovascular hospitalization, • VARC-defined prosthetic valve thrombosis, • VARC-3 defined Cardiovascular hospitalization, • Death at 2 years (national mortality database)

Interventions

Sponsors

Centre Hospitalier Universitaire De Caen Normandie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
• Any non-procedure-related bleeding defined by the VARC classification 1 to 4, • Major or disabling or life threatening bleeding defined by VARC classification 2 or 3, • Major 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, • Type 1 VARC classification bleeding, • Type 2 VARC classification bleeding, • Type 3 VARC classification bleeding, • Fatal bleeding defined by Type 4 VARC classification, • Death, • Cardiovascular death, • Type 1 myocardial infarction based on the universal definition, • Stroke defined by NeuroARC types 1a, or 1d ischemic CNS injury, • Intracranial bleeding defined by NeuroARC type 1aH, 1b, 1c hemorrhagic CNS injury, • Transient cerebral ischemic attack defined by NeuroARC type 3a, • Any hospitalization, • Cardiovascular hospitalization, • VARC-defined prosthetic valve thrombosis, • VARC-3 defined Cardiovascular hospitaliza

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026