Evidence map›Paper›PMID 40118800›Full record

ArticleJournal of the American Heart Association2025

Rationale and Design of the CREATE Trial: A Multicenter, Randomized Comparison of Continuation or Cessation of Single Antithrombotic Therapy at 1 Year After Transcatheter Aortic Valve Replacement.

Ran Liu, Yang Li, Lihua Zhang, Zhinan Lu, Zhaolin Fu, Thomas Modine, Hasan Jilahawi, Stuart Pocock, Yongjian Wu, Guangyuan Song

Abstract readClinical Trial Protocol
In one paragraph

Article in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Third Year in Review, Fourth Year in Preview, and the 2025Journal of the American Heart Association · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Ran LiuInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.ORCID 0000-0002-5025-0927
Yang LiInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.ORCID 0000-0002-6973-1333
Lihua ZhangCardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.ORCID 0009-0003-2675-7298
Zhinan LuInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.ORCID 0000-0002-5095-2013
Zhaolin FuInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.ORCID 0000-0003-4787-9481
Thomas ModineDepartment of Cardiology and Cardio-Vascular Surgery Hôpital Cardiologique de Haut-Leveque, Bordeaux University Hospital Bordeaux France.ORCID 0000-0003-4169-3766
Hasan JilahawiCedars-Sinai Medical Center Smidt Heart Institute Los Angeles CA USA.ORCID 0000-0002-8397-9431
Stuart PocockLondon School of Hygiene and Tropical Medicine London United Kingdom.ORCID 0000-0003-2212-4007
Yongjian WuCardiovascular Disease Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College Beijing China.ORCID 0000-0002-6113-0453
Guangyuan SongInterventional Center of Valvular Heart Disease Beijing Anzhen Hospital, Capital Medical University Beijing China.ORCID 0000-0002-7868-6132

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent guidelines and expert consensus recommend lifelong single antiplatelet therapy for patients undergoing transcatheter aortic valve replacement who have no indication for anticoagulation or dual antiplatelet therapy. However, there is no direct evidence from randomized controlled trials supporting this practice. Furthermore, the optimal duration of antiplatelet therapy in this population has not been adequately investigated. METHODS AND

resultsCREATE (A Multicenter Randomized Controlled Study to Evaluate Cessation of Antithrombotic Therapy at 1 Year in TAVR Patients-The CREATE Study) is a prospective, multicenter, open-label, randomized controlled trial for patients who have undergone successful transcatheter aortic valve replacement and have no indication for long-term oral anticoagulation or antiplatelet therapy. Eligible patients are free from major bleeding and ischemic events for 1 year postprocedure before being randomized 1:1 to single antiplatelet therapy (control group) or no antiplatelet therapy (experimental group). The primary efficacy end point is the incidence of bleeding events, defined by the VARC-3 (Valve Academic Research Consortium-3) criteria, at 1-year postrandomization. The primary safety end point is a composite of cardiac death, myocardial infarction, and ischemic stroke at 1 year. The trial is powered for both superiority in efficiency and noninferiority in safety. Accordingly, a total of 3380 patients will be enrolled.

conclusionsThe CREATE trial aims to assess if stopping antiplatelet therapy at 1-year after transcatheter aortic valve replacement reduces bleeding risk without increasing ischemic events in patients not requiring chronic antithrombotic therapy. REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: ChiCTR2400087454.

Indexed as

Aortic Valve StenosisFibrinolytic AgentsPlatelet Aggregation InhibitorsTranscatheter Aortic Valve ReplacementDrug Administration ScheduleEquivalence Trials as TopicFemaleHemorrhageHumansMaleMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeFibrinolytic AgentsPlatelet Aggregation Inhibitorsantiplatelet therapyaortic stenosistranscatheter aortic valve replacementtreatment withdrawal

Identifiers

PMID40118800
PMCPMC12132840

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.