Heart Valve Disease3D-INTENSITYNCT01996657

D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement

An observational study of Heart Valve Disease, run by Wuhan Asia Heart Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Heart Valve Disease
What is being tested?: Warfarin
Type of treatment: Pill or oral medicine
How many people: 772 participants
Where: 2 sitesChina
Study dates: Jan 2013to Jun 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin

Who may be able to join

age>18years,male or female without pregnancy;
Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).
Exclusion Criteria: Patients with following diseases within 3 months.
deep venous thromboembolism
Pulmonary embolism

Show all 10Show fewer

Aortic dissection
stroke
Cerebral hemorrhage
Myocardial infarction

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

China2 sites

WAHH
Wuhan, Hubei, 430000
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement

The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Read the detailed description

Background: The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.

Objective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Methods: A single-center, prospective study was performed. 748 Patients with mechanical valve replacement who had received oral anticoagulation. The patients were randomly assigned to three groups The intensity of anticoagulation for group one was standard intensity (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times at 3 month later. In case of D-dimer level elevated, adjusted the intensity of anticoagulation to standard level. The endpoint of the study was the subsequent thromboembolic and major bleeding during an average follow-up of 2 years.

Conditions: Heart Valve Disease
Being tested: Warfarin
Keywords: mechanical valves replacement, INR, D-dimer, thromboembolic events
Medical subject headings: Heart Valve Diseases, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WarfarinDrug
Also called Warfarin Sodium Tablets

Study groups in NCT01996657
Study group	Role	What they receive
Standard intensity of anticoagulation		After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5). Receives: Drug: Warfarin
Low intensity and adjusted by elevated D-dimer		The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level. Receives: Drug: Warfarin
Low intensity without adjustment		The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6), Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

Bleeding Events;
The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Measured: Up to 24 months
Thrombotic Events
The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Measured: 24 months

Secondary outcomes (1)

All Cause Deaths
The deaths from all causes
Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jun 2016

First posted27 Nov 2013 (estimated)
Study startJan 2013
Primary completionMay 2016
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Heart Valve 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 772 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01996657
Sponsor's protocol ID: 2013-P-002
Acronym: 3D-INTENSITY
Status last verified: Jun 2016
First submitted: 4 Nov 2013
Last updated: 26 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Publications

Zhang L, Long Y, Xiao H, Yang J, Liu X, Zhang Z. D-Dimer to Predict the Clinical Outcomes in Patients with Mechanical Heart Valve Replacement During Oral Anticoagulation Therapy. Int Heart J. 2019 May 30;60(3):631-636. doi: 10.1536/ihj.18-237. Epub 2019 Apr 25.
PubMed 31019170
Zhang L, Zheng X, Long Y, Wu M, Chen Y, Yang J, Liu Z, Zhang Z. D-dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial. J Thromb Haemost. 2017 Oct;15(10):1934-1941. doi: 10.1111/jth.13782. Epub 2017 Sep 20.
PubMed 28762606

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
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Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
RecruitingObservational study
Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry™): Registry Purpose and Research Objective
Aortic Valve Stenosis
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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Human Experimental Models of Pain (HEMP)
Acute Pain

All Heart Valve Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement
ClinicalTrials.gov ID: NCT01996657
Acronym / sponsor ID: 3D-INTENSITY / 2013-P-002
Conditions: Heart Valve Disease
Keywords: mechanical valves replacement, INR, D-dimer, thromboembolic events
Study type: Observational
Recruitment status: Completed
Enrolment: 772 participants (actual)
Lead sponsor: Wuhan Asia Heart HospitalUniversity, hospital or other
Study start: Jan 2013
Primary completion: May 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 27 Nov 2013 (estimated)
Results: Posted 26 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Detailed description

Objective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Standard intensity of anticoagulation	–	Drug: WarfarinAfter mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Low intensity and adjusted by elevated D-dimer	–	Drug: WarfarinThe intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Low intensity without adjustment	–	Drug: WarfarinThe intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin

Key inclusion criteria (10 listed)

age>18years,male or female without pregnancy;
Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;
The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).
Exclusion Criteria: Patients with following diseases within 3 months.
deep venous thromboembolism

Key exclusion criteria (0 listed)

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
WarfarinAlso: Warfarin Sodium Tablets	Drug	Low intensity and adjusted by elevated D-dimer, Low intensity without adjustment, Standard intensity of anticoagulation

Primary outcome

Bleeding Events;
Time frame: Up to 24 months
The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Thrombotic Events
Time frame: 24 months
The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.

1 secondary outcome

All Cause Deaths
Time frame: Up to 24 months

Results and safety

Results posted to the registry on 26 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Intensity of Anticoagulation	250	237
Low Intensity and Adjusted by Elevated D-dimer	250	239
Low Intensity Without Adjustment	248	234

Primary outcome: Bleeding Events;

Time frame: Up to 24 months. Count of participants. Unit: Participants

Measure	Standard Intensity of Anticoagulation n = 237	Low Intensity and Adjusted by Elevated D-dimer n = 239	Low Intensity Without Adjustment n = 234
Value	16	3	4

Primary outcome: Thrombotic Events

Time frame: 24 months. Count of participants. Unit: Participants

Measure	Standard Intensity of Anticoagulation n = 237	Low Intensity and Adjusted by Elevated D-dimer n = 239	Low Intensity Without Adjustment n = 234
Value	5	5	14

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Intensity of Anticoagulation	24 of 245 (9.8%)	0 of 245 (0%)	12 of 245
D-dimer-guided Adjustmentd of Anticoagutlation Intensity	9 of 245 (3.7%)	0 of 245 (0%)	4 of 245
Low Intensity Without Adjustment	20 of 242 (8.3%)	0 of 242 (0%)	5 of 242

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31019170Zhang L, Long Y, Xiao H, Yang J, Liu X, Zhang Z. D-Dimer to Predict the Clinical Outcomes in Patients with Mechanical Heart Valve Replacement During Oral Anticoagulation Therapy. Int Heart J. 2019 May 30;60(3):631-636. doi: 10.1536/ihj.18-237. Epub 2019 Apr 25.
Derived from this study: PubMed 28762606Zhang L, Zheng X, Long Y, Wu M, Chen Y, Yang J, Liu Z, Zhang Z. D-dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial. J Thromb Haemost. 2017 Oct;15(10):1934-1941. doi: 10.1111/jth.13782. Epub 2017 Sep 20.
Individual participant dataSharing planned: Undecided

Related trials for Heart Valve Disease

Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Recruiting
Tricuspid Regurgitation Treatment With LAPLACE Transcatheter Tricuspid Valve Replacement System
Severe Tricuspid Valve Regurgitation, Tricuspid Valve Regurgitation
RecruitingObservational study
Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy Registry (STS/ACC TVT Registry™): Registry Purpose and Research Objective
Aortic Valve Stenosis
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain

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.

zhang zhenlu, PH.D study director

Wuhan Asia Heart Hospital

Zhou xin, Doctor study chair

Wuhan Asia Heart Hospital

liu ze jin, PH.D study director

Wuhan Asia Heart Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Valve Disease, run by Wuhan Asia Heart Hospital at 2 sites 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 10 inclusion and 0 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: finished, as of the sponsor's last update on 26 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bleeding Events; (time frame: Up to 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?

On the ClinicalTrials.gov record for NCT01996657, which also lists 2 linked publications.

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 Jun 2017.