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NCT05375474
Antithrombotic Strategy Based on Clinical Events and 4D-CT for Patients After TAVR
Phase 4 trial testing Oral anticoagulation therapy in Transcatheter Aortic Valve Replacement in 650 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | China National Center for Cardiovascular Diseases |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 650 |
| Start date | 27 July 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Oral anticoagulation therapy — full drug profile →
- Single antiplatelet therapy — full drug profile →
Conditions studied
- Transcatheter Aortic Valve Replacement — all drugs for Transcatheter Aortic Valve Replacement →
- Antithrombotic Therapy — all drugs for Antithrombotic Therapy →
- Bioprosthetic Valve Thrombosis — all drugs for Bioprosthetic Valve Thrombosis →
Sponsor
China National Center for Cardiovascular Diseases — full company profile →
Who can join
Adults 18 to 85, any sex, with Transcatheter Aortic Valve Replacement or Antithrombotic Therapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, open-label, randomized controlled study meant to test the superior efficacy of oral anticoagulation (OAC) therapy versus single antiplatelet therapy (SAPT) in patients after TAVR. Patients who accept successful TAVR will be randomized to receive either the OAC group (Vitamin-K antagonists) or the SAPT group (aspirin) for 6 months on a 1:1 ratio. After that, patients from both groups will be treated with single antiplatelet therapy (aspirin). All patients will be followed for 1 year to test the difference between net clinical benefits and bioprosthetic valve thrombosis diagnosed by 4D-CT.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Early 6 months usage of single anTiplAtelet OR anTicoAgulant followed by single antiplatelet after transcatheter aortic valve replacement: protocol for a multicentre, open-label, randomised controlled clinical trial.
Hu X, Xu H, Wang C, Wang Y, et al · · 2023 · cited 1× · PMID 37989381 · DOI 10.1136/bmjopen-2023-076781
Verify or expand the search:
- PubMed search for NCT05375474
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oral anticoagulation therapy
Trials testing the same drug.
- NCT03838341 — Stand-alone Totally Thoracoscopic Left Atrial Appendage Occlusion Using AtriClip® Device in Non-valvular Atrial Fibrilla · unknown
Other recruiting trials for Transcatheter Aortic Valve Replacement
Currently open trials in the same condition.
- NCT06559332 — Coronary Artery Disease Assessment Strategies in TAVI Patients · NA · recruiting
- NCT06896227 — TAVR: The Impact of Prothesis Positioning on Valvular and Coronary Hemodynamics · NA · recruiting
- NCT06420830 — Valve Performance of the SAPIEN 3 Ultra RESILIA Valve: A Prospective Registry With Central Echocardiography Analysis. · recruiting
- NCT05758701 — CT TAVR Abdomen Study · Phase 4 · recruiting
- NCT06000943 — Ischemic And Bleeding Risk Assessment After TAVR · recruiting
Other China National Center for Cardiovascular Diseases trials
Trials by the same sponsor.
- NCT07514988 — Sirolimus-Coated vs Paclitaxel-Coated DCBs in ACS Treatment · NA · not yet recruiting
- NCT07476456 — Skeletal Muscle Multi-omics Analysis and Risk Tailoring in Sudden Cardiac Death · not yet recruiting
- NCT07302659 — Aortic No-Touch vs Partial Aortic Clamping in Off-Pump CABG · NA · recruiting
- NCT07482683 — Predicting Post-Cardiac Surgery Acute Kidney Disease: A Machine Learning Approach · not yet recruiting
- NCT06787430 — Effects of Nicorandil on Microvascular Dysfunction in Patients With STEMI Undergoing Primary PCI · Phase 4 · not yet recruiting
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 NCT05375474 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by China National Center for Cardiovascular Diseases
- Last refreshed: 23 October 2023
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/NCT05375474.
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