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Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography (4DCT)

NCT02833948 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2020-01-18

Study results available
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Summary

The aortic valve is located between the left ventricle and the aorta. Patients with symptomatic, severe aortic valve stenosis conventionally have it surgically replaced requiring direct access to the heart through the chest. Transcatheter aortic valve replacement (TAVR) is now a well-established alternative for treating severe aortic valve stenosis. Both types of intervention improve prognosis and alleviate symptoms.

The optimal choice of blood thinning therapy after TAVR is unknown. It has been reported that leaflet thrombosis with reduced leaflet motion can occur and this phenomenon has been suggested to be potentially related with neurological events. In addition, the occurence of this phenomenon can be reduced with anticoagulation blood thinning therapy.

The purpose of this study is to evaluate if anticoagulation compared to the usual double platelet inhibitor therapy after TAVR can reduce the risk of leaflet thrombosis.

Conditions

Interventions

DRUG

Acetylsalicylic acid

Drug: Acetylsalicylic acid: 75 - 100 mg OD (for first 90 days only in arm 1)

DRUG

Clopidogrel

Drug: Clopidogrel 75 mg OD for first 90 days

DRUG

Rivaroxaban

Drug: Rivaroxaban (Xarelto): 10 mg OD (once-daily)

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Cardialysis BV

    collaborator INDUSTRY

  • ECRI bv

    lead INDUSTRY

Principal Investigators

  • Lars Søndergaard, MD;DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2019-03-06

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Netherlands
  • Sweden
  • Switzerland

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02833948 on ClinicalTrials.gov