Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy

NCT ID: NCT03885180

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-03-30

Brief Summary

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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.

Detailed Description

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Patients with BHV were screened and enrolled in this study. D-dimer levels were measured in the sixth months after BHV operation but before withdrawal of warfarin. Patients with elevated D-dimer were randomized to extend anticoagulation therapy group and routine stopping anticoagulation group.

Conditions

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Valve Heart Disease Anticoagulants; Increased

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Stop anticoagulation group

Just stop oral anticoagulation like routine

Group Type NO_INTERVENTION

No interventions assigned to this group

Extend anticoagulation group

Extended the duration anticoauglation to 12 months

Group Type EXPERIMENTAL

Warfarin Sodium

Intervention Type DRUG

Extending warfarin anticoagulation

Interventions

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Warfarin Sodium

Extending warfarin anticoagulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients received BHV within 3 months

Exclusion Criteria

* Recently throboemblism within 6 months
* Recently bleedings within 3 months
* Evaluated lifetime less than 2 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Litao Zhang, MD

Head of anticoagulation clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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zhang li tao, MD.P

Role: primary

+86 02765796739

Other Identifiers

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2019-P-026

Identifier Type: -

Identifier Source: org_study_id

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