NCT03885180

Brief Summary

Guidelines recommended that patients with bioprosthetic heart valves (BHV) only need 6 months oral anticoagulation therapy after operation. However, a small part of patients still suffered thrombotic events after withdrawal of warfarin, which means these patients may need extend anticoagulation therapy. D-dimer, a sensitive marker of thrombosis or prethromboembolism state. Previous studies have demostrated that patients with elevated D-dimer levels have significant more clinical outcomes than those with nagative D-dimer levels. The aim of this study was to evaluate whether D-dimer could guide the duration of oral anticoagulation therapy in patients with BHV.

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
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

March 19, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2021

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 19, 2019

Last Update Submit

March 24, 2019

Conditions

Valve Heart DiseaseAnticoagulants; Increased

Keywords

bioprosthetic heart valvesoral anticoagulationthrombotic events

Outcome Measures

Primary Outcomes (2)

  • Thrombotic events

    Stroke, DVT, PE, valve thrombosis

    24 months

  • Bleeding events

    24 months

Study Arms (2)

Extend anticoagulation group

EXPERIMENTAL

Extended the duration anticoauglation to 12 months

Drug: Warfarin Sodium

Stop anticoagulation group

NO INTERVENTION

Just stop oral anticoagulation like routine

Interventions

Warfarin SodiumDRUG

Extending warfarin anticoagulation

Extend anticoagulation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients received BHV within 3 months

You may not qualify if:

  • Recently throboemblism within 6 months
  • Recently bleedings within 3 months
  • Evaluated lifetime less than 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of anticoagulation clinic

Study Record Dates

First Submitted

March 19, 2019

First Posted

March 21, 2019

Study Start

March 20, 2019

Primary Completion

March 1, 2021

Study Completion

March 30, 2021

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

CN(1)