NCT04171726

Brief Summary

A single-center, investigator-initiated, single arm interventional study in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) in the Erasmus Medical Center in Rotterdam (NL). Study population will be patients undergoing TAVR with no formal indication for oral anticoagulant (OAC) and no dual antiplatelet therapy (DAPT) requirement for coronary stents. Primary endpoint is the incidence of leaflet thickening on MSCT after three months of edoxaban treatment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2019

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

3.8 years

First QC Date

November 19, 2019

Last Update Submit

July 25, 2022

Conditions

Aortic Valve Stenosis

Keywords

ThrombosisAortic Valve StenosisHeart Valve DiseasesVentricular Outflow ObstructionCardiovascular DiseasesEmbolism and ThrombosisVascular DiseasesHeart DiseasesFactor Xa InhibitorsAnticoagulants

Outcome Measures

Primary Outcomes (1)

  • Incidence of aortic valve leaflet thickening after TAVI as assessed by cardiac 4D computed tomography scan (4DCT)

    total of participants with aortic valve thickening after TAVI

    3 months after TAVI

Study Arms (1)

Edoxaban

EXPERIMENTAL

treatment with edoxaban

Drug: Edoxaban

Interventions

EdoxabanDRUG

A non-vitamin K antagonist (VKA) oral anticoagulant that selectively inhibits factor Xa.

Edoxaban

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Completed successful elective TAVI for severe native aortic valve stenosis with any commercially-available transcatheter heart valve (THV).
  • Correct positioning of a single prosthetic heart valve
  • Device success, defined by:
  • Mean aortic valve gradient \< 20 mmHg
  • Peak transvalvular velocity \< 3.0 m/s
  • Aortic valve regurgitation of 2 or less
  • No periprocedural complications.
  • No overt stroke
  • No uncontrolled bleeding
  • No major vascular complication defined by the Valve academic research committee 2 (VARC-2) consensus
  • No formal indication for oral anticoagulation
  • Prevention of thromboembolic complications in patients with atrial fibrillation
  • Prevention for recurrent venous thromboembolism
  • Prevention for recurrent pulmonary embolism

You may not qualify if:

  • History of life-threatening or major bleeding event ≥ Bleeding academic research committee (BARC) 3b definitions within the last year.
  • Conditions with a high risk of bleeding
  • Active peptic ulcer or upper gastrointestinal bleeding (\< 3 months)
  • Malignancy with high risk of bleeding
  • Recent unresolved brain of spinal injury
  • Spinal or ophthalmic surgery within last 3 months prior to enrolment
  • Intracranial haemorrhage
  • Esophagal varices
  • Arteriovenous malformations with high risk of bleeding
  • Vascular aneurysms
  • Major intraspinal or intracerebral vascular abnormalities
  • Hypersensitivity or contraindications to edoxaban
  • No percutaneous coronary intervention within 6 months prior to randomization (requiring DAPT after TAVR)
  • Dialysis-dependency or glomerular filtration rate \< 30 mL/min at time of enrollment
  • Active bleeding or bleeding diathesis including thrombocytopenia (platelet count \< 50.000 cells/UL), thromboasthenia, haemophilia or von Willebrand disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015GD, Netherlands

RECRUITING

Related Publications (5)

  • Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

    PMID: 26436963BACKGROUND

  • Sondergaard L, De Backer O, Kofoed KF, Jilaihawi H, Fuchs A, Chakravarty T, Kashif M, Kazuno Y, Kawamori H, Maeno Y, Bieliauskas G, Guo H, Stone GW, Makkar R. Natural history of subclinical leaflet thrombosis affecting motion in bioprosthetic aortic valves. Eur Heart J. 2017 Jul 21;38(28):2201-2207. doi: 10.1093/eurheartj/ehx369.

    PMID: 28838044BACKGROUND

  • Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.

    PMID: 28330690BACKGROUND

  • Adrichem R, van Wiechen MP, Knol WG, Hokken TW, Ooms JF, van den Dorpel MMP, Verhemel S, Kardys I, Nuis RJ, Daemen J, Hirsch A, Budde RPJ, Van Mieghem NM. Edoxaban Monotherapy and Incidence of Transcatheter Heart Valve Leaflet Thrombosis - The Rotterdam Edoxaban (REDOX) Study. Catheter Cardiovasc Interv. 2025 Feb;105(2):375-384. doi: 10.1002/ccd.31300. Epub 2024 Nov 22.

    PMID: 39575924DERIVED

  • van Wiechen MP, El Azzouzi I, Knol WG, Adrichem R, Hokken TW, Ooms JF, de Ronde-Tillmans MJ, Daemen J, de Jaegere PP, Hirsch A, Budde RPJ, Van Mieghem NM. Leaflet Thickening and Motion After Transcatheter Aortic Valve Replacement: Design and Rationale of the Rotterdam Edoxaban Trial. Cardiovasc Revasc Med. 2022 Nov;44:67-70. doi: 10.1016/j.carrev.2022.06.011. Epub 2022 Jun 17.

    PMID: 35787831DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisThrombosisHeart Valve DiseasesVentricular Outflow ObstructionCardiovascular DiseasesEmbolism and ThrombosisVascular DiseasesHeart Diseases

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Aortic Valve Disease

Study Officials

  • Nicolas M Van Mieghem, MD, PhD

    Erasmusm MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas M Van Mieghem, MD, PhD

CONTACT

+31(0)107035260n.vanmieghem@erasmusmc.nl

Maarten P van Wiechen, MD

CONTACT

+31(0)107038896m.vanwiechen@erasmusmc.nl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 19, 2019

First Posted

November 21, 2019

Study Start

August 1, 2019

Primary Completion

June 1, 2023

Study Completion

September 1, 2023

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)