NCT06000943 Ischemic And Bleeding Risk Assessment After TAVR
| NCT ID | NCT06000943 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Niguarda Hospital |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2024-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2023-08-01 with a primary completion date of 2024-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria * All patients with severe aortic stenosis undergoing TAVR. * Availability of changes in antithrombotic therapy at 1 month, 90 days, and 1 year after TAVR. Exclusion Criteria * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06000943 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06000943 currently recruiting?
Yes, NCT06000943 is actively recruiting participants. Contact the research team at giuseppe.esposito@yahoo.com for enrollment information.
Where is the NCT06000943 trial being conducted?
This trial is being conducted at Aalst, Belgium, Santiago, Chile, Prague, Czechia, Milan, Italy and 8 additional locations.
Who is sponsoring the NCT06000943 clinical trial?
NCT06000943 is sponsored by Niguarda Hospital. The trial plans to enroll 2,500 participants.