Last reviewed · How we verify
NCT06000943: FOCUS ONE
Ischemic And Bleeding Risk Assessment After TAVR
trial testing Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT in Aortic Valve Stenosis in 2,500 participants. Currently enrolling.
1 November 2024
Quick facts
| Lead sponsor | Niguarda Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 2,500 |
| Start date | 1 August 2023 |
| Primary completion | 1 November 2024 |
| Estimated completion | 15 December 2026 |
| Sites | 12 locations across Italy, Belgium, Chile, Spain, Czechia |
Drugs / interventions tested
- Low vs Intermediate vs High surgical risk stratified according with SAPT/DAPT/OAC and OAC+SAPT
Conditions studied
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
- Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →
Sponsor
Niguarda Hospital
Who can join
18 and older, any sex, with Aortic Valve Stenosis or Transcatheter Aortic Valve Replacement. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06000943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Niguarda Hospital trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06000943 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Niguarda Hospital
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06000943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing