Ischemic And Bleeding Risk Assessment After TAVR

Recruiting now

Conditions studied: Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement

In brief

Transcatheter aortic valve replacement (TAVR) represents an effective treatment to improve symptoms and prognosis in patients with symptomatic severe aortic stenosis (AS) (1-2). Giving an established uniform approach towards anticoagulation and antithrombotic therapy after TAVR in the post POPULAR-TAVI era, recent data coming from the analysis of different trials, highlight the relevance of the patient's background on the occurrence of ischemic and bleeding events. Despite this a targeted antithrombotic strategy remains unexplored and all patients undergoing TAVR without other indication to DAPT or OAC, were currently treated according with the concept of "less is more" (only SAPT or only OAC) regardless the risk level (5-6). The keys points of the project will be 1) the assessment of ischemic and bleeding risk after TAVR stratified according with antithrombotic therapy and surgical risk; 2) the evaluation of the impact of prostheses type and the complete blood count variables (hemoglobine and platelets) on the daily average ischemic and bleeding risk and 3) the evaluation of the dynamic therapeutic changes after TAVR during the follow up.

Key facts

Study ID

NCT06000943

Run by

Niguarda Hospital

People needed

2500

Starts

2023-08-01

Expected to finish

2026-12-15

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All patients with severe aortic stenosis undergoing TAVR.
• Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR.

You may not qualify if…

• Patients who died during the index procedure
• Patients in triple antithrombotic therapy at discharge
• Patients with a known prognosis less than 1 year at the time of TAVR

Where it is running

• OLV Hospital — Aalst, Belgium (enrolling)
• Complejo Asistencial Dr. Sótero del Río — Santiago, Chile (enrolling)
• Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady — Prague, Czechia (enrolling)
• ASST GOM Niguarda — Milan, Italia, Italy (enrolling)
• Humanitas Research Hospital — Rozzano, Milano, Italy (enrolling)
• IRCCS Policlinico San Donato — San Donato Milanese, Milano, Italy (enrolling)
• IRCCS Ospedale Policlinico San Martino — Genova, Italy (enrolling)
• Ospedale Galeazzi Sant'Ambrogio — Milan, Italy (enrolling)
• San Carlo Hospital — Potenza, Italy (enrolling)
• Azienda Ospedaliera Sant'Andrea — Roma, Italy (enrolling)
• A.O.U. Città della Salute e della Scienza di Torino — Torino, Italy (enrolling)
• Puerto Real University Hospital, Puerto Real — Cadiz, Spain (enrolling)

Full record on ClinicalTrials.gov

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