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Single antiplatelet treatment with Ticagrelor or Aspirin after Transcatheter Aortic Valve Implantation: multicenter randomized clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509290-22-00
Acronym
REAC-TAVI 2
Enrollment
1200
Registered
2024-01-16
Start date
2022-01-21
Completion date
Unknown
Last updated
2025-09-16

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

Conditions

Severe Symptomatic Aortic Stenosis

Brief summary

All-cause mortality at 12 months after TAVI, Transient ischemic attack (TIA) or stroke at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Bleeding at 12 months after TAVI according BARC, Net Adverse Clinical Event(s)

Detailed description

All major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC, Incidence of subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4DCT) imaging (performed only in pre-specified centers), Gender, Age, Valve type, Comorbilities, All-caused mortality at 12 months after TAVI, Stroke/TIA at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography at 12 months after TAVI, Thrombotic and bleeding risk score

Interventions

Sponsors

Fundacion Biomedica Galicia Sur
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
All-cause mortality at 12 months after TAVI, Transient ischemic attack (TIA) or stroke at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Bleeding at 12 months after TAVI according BARC, Net Adverse Clinical Event(s)

Secondary

MeasureTime frame
All major bleeding (type 2, 3 and 5) at 12 months after TAVI according BARC, Incidence of subclinical valve thrombosis (SVT) detected by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) at 3 and 12 months after TAVI assessed by 4-dimensional computed tomography (4DCT) imaging (performed only in pre-specified centers), Gender, Age, Valve type, Comorbilities, All-caused mortality at 12 months after TAVI, Stroke/TIA at 12 months after TAVI, Myocardial infarction at 12 months after TAVI, Progressive angina leading to emergency evaluation, rehospitalization or new coronary angiography at 12 months after TAVI, Thrombotic and bleeding risk score

Countries

Italy, Portugal, Spain

Outcome results

None listed

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