Valve Heart DiseaseREDUCENCT03885180
Randomized Evaluation of D-dimer Guiding dUration of Oral antiCoagulation thErapy
A study testing Warfarin Sodium in people with Valve Heart Disease and Anticoagulants; Increased, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Valve Heart Disease, Anticoagulants; Increased
- What is being tested?
- Warfarin Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients received BHV within 3 months
Who cannot join
- Recently throboemblism within 6 months
- Recently bleedings within 3 months
- Evaluated lifetime less than 2 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
zhang li tao, MD.P, +86 02765796739, zhangleetau@163.com
zhang li tao, MD.P
About this study
Official title: Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
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.
Read the detailed description
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
- Valve Heart Disease, Anticoagulants; Increased
- Being tested
- Warfarin Sodium
- Keywords
- bioprosthetic heart valves, oral anticoagulation, thrombotic events
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warfarin SodiumDrug
Extending warfarin anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Extend anticoagulation group | Experimental | Extended the duration anticoauglation to 12 months Receives: Drug: Warfarin Sodium |
| Stop anticoagulation group | No intervention | Just stop oral anticoagulation like routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic events
Stroke, DVT, PE, valve thrombosis
Measured: 24 months
Bleeding events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start20 Mar 2019
- Primary completion1 Mar 2021 (estimated)
- Study completion30 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Asia Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Litao Zhang, MD, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885180
- Sponsor's protocol ID
- 2019-P-026
- Acronym
- REDUCE
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of D-dimer Guiding Duration of Oral Anticoagulation Therapy in Patients With Bioprosthetic Heart Valves
- ClinicalTrials.gov ID
- NCT03885180
- Acronym / sponsor ID
- REDUCE / 2019-P-026
- Conditions
- Valve Heart Disease, Anticoagulants; Increased
- Keywords
- bioprosthetic heart valves, oral anticoagulation, thrombotic events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extend anticoagulation group | Experimental | Drug: Warfarin SodiumExtended the duration anticoauglation to 12 months |
| Stop anticoagulation group | No intervention | –Just stop oral anticoagulation like routine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients received BHV within 3 months
Key exclusion criteria (3 listed)
- Recently throboemblism within 6 months
- Recently bleedings within 3 months
- Evaluated lifetime less than 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Warfarin SodiumExtending warfarin anticoagulation | Drug | Extend anticoagulation group |
Primary outcome
Thrombotic events
Time frame: 24 months
Stroke, DVT, PE, valve thrombosis
Bleeding events
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warfarin Sodium in people with Valve Heart Disease and Anticoagulants; Increased, run by Wuhan Asia Heart Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic events (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.