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Ischemic And Bleeding Risk Assessment After TAVR

NCT06000943 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Valve Stenosis
  • Transcatheter Aortic Valve Replacement

Interventions

OTHER

Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT

All patients undergoing TAVR will be stratified according with surgical risk level and all combination of antithrombotic therapy at discharge Low risk (SAPT vs DAPT and OAC vs OAC+SAPT) Intermediate risk (SAPT vs DAPT and OAC vs OAC+SAPT) High risk (SAPT vs DAPT and OAC vs OAC+SAPT)

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-11-01
Completion
2026-12-15

Countries

  • Belgium
  • Chile
  • Czechia
  • Italy
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06000943 on ClinicalTrials.gov