ClinicalTrials.gg
CompletedNCT03264937SMARTUpdated Jun 19, 2019

Social-software iMproving wARfarin Therapy

An interventional study of Social-software management in Anticoagulants Causing Adverse Effects in Therapeutic Use and Patient Compliance, sponsored by Wuhan Asia Heart Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-19.

Sponsored by Wuhan Asia Heart Hospital · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
735
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 23 studies in Patient Compliance with a site in China — 6 open to participants now, 6 under way, none of them phase 3. Patient Compliance · China.

Enrollment
3rd of 14
735 · median 263
Started
2017
with 4 others
No phase
8 of 23
1 open now
Registered
7th of 23
by date

Among the 23 studies in Patient Compliance with a site in China, this one is the 3rd largest by enrollment of the 14 interventional ones that give a count, is one of 5 that started in 2017, is one of 8 with no phase, and was the 7th registered.

Patient Compliance

752 studies on the registry are indexed under Patient Compliance; 72 are open to participants now.

Browse Patient Compliance studies →

Open to participants now

6 of the 23 studies in Patient Compliance with a site in China are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 45 Patient Compliance studies recruiting now, 25 (56%) set no upper age limit and 13 (29%) stop at 75 or younger; 11 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 23 studies in Patient Compliance with a site in China, or all of them as a file.
02

Study summary

Poor anticoagulation quality is a major problem among Chinese patients receiving warfarin therapy in traditional health care settings. Improving warfarin therapy has been crucial for Chinese patients. Wechat is social-software in China. Most of all Chinese adults use Wechat, as well as our patients. So we set up a Wechat-based mini-program to instruct Chinese patients' warfarin therapy. We aim to assess whether social software could improve warfarin therapy in Chinese patients by conducting a single-centre, open-label, prospective, randomized clinical trial.

Read the detailed description

Social software is becoming a necessary of life. Wechat, powered by Tencent company, is the most popular social software in China. People can chat with others no matter how far away from each other.

Anticoagulation Quality is very important for patients receiving warfarin anticoagulation therapy, which is usually evaluated Time in therapeutic range (TTR). It is reported that TTR is very low (38.8%) in China patients. So we are planning to introduce the social software to set up a bridge for clinicians and their patients, to instruct warfarin therapy. We aim to investigate whether social software could be used to improve warfarin anticoagulation quality of Chinese patients.

We planned to enrol enough eligible patients receiving warfarin therapy due to the mechanical valves in a randomized controlled trial. Warfarin-treated patients were assigned to social software management group ( in which warfarin therapy was guided via the social platform by experienced clinicians) or to the traditional management control group (in which warfarin therapy was managed with traditional model). The primary outcomes the first time to bleeding or thrombotic events, the secondary outcomes were an elevation in time in therapeutic range (TTR) of international normalized ratio (INR), reduction in INR variation and number of extremely high INR results during 18 months.

03

Conditions studied

  • Anticoagulants Causing Adverse Effects in Therapeutic Use
  • Patient Compliance

Browse trials for

Keywords

  • TTR
  • INR
  • Warfarin
  • social software
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Received mechanical valve replacement;
  • Receiving warfarin anticoagulation therapy;
  • Have smartphone and Know how to use wechat application and our mini-program;
  • be expected to survive for the duration of the study;
  • not be suffering from intracranial bleeding (intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke) or any other described in the warfarin package insert;
  • be willing to be randomized;
  • sign the form;
  • not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion criteria

Exclusion Criteria:

  • subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major described in the warfarin package insert within the last month
  • subject enrolled in another randomized clinical trial that involves a drug or device intervention
  • subject is not able to follow the protocol and all related instructions and does not have a caregiver with these skills
  • Patients were considered being not suitable for this study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
735 participants (actual)

Study arms

  • Experimental
    Social-software management group

    We set up a mini-program based on wechat application. We instruct warfarin therapy via social-software including dose adjustment, answer questions, remind monitoring INR et.al.

    Behavioral: Social-software management

  • No intervention
    Routine management group

    This is the control group, Warfarin therapy was managed via traditional style without social software intervention.

Interventions

  • BehavioralSocial-software management

    Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.

06

What researchers measure

Primary outcomes

  1. Time to First Event

    Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage,gastrointestinal bleeding etc.

    Time frame: Up to 18 months

Secondary outcomes

  1. Time in therapeutic range

    Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio

    Time frame: Up to 18 months

  2. Individual variation of International Normalized Ratio (INR)

    Standard deviation (SD) of individual INR results

    Time frame: Up to 18 months

  3. Times of extremely high International Normalized Ratio (INR) values

    Times of INR results above 4.0; Times of INR results above 12.0

    Time frame: Up to 18 months

07

Study locations

1 site
  • WAHH
    Wuhan, Hubei 430000, China
08

References and documents

Individual participant data

Plan to share: Yes — We are going to make individual participant data (IPD) available to other researchers after our paper published

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Mar 2019, 18 months.

Of 224 non-industry interventional studies with no phase under Patient Compliance, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 38. This study's 18 months is close to that.

Counting every sponsor, half of 237 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2017
First posted
Aug 29, 2017
StartActual
Sep 1, 2017
Primary completionActual
Mar 1, 2019
CompletionActual
Mar 8, 2019
Last update
Jun 19, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03264937
Lead sponsor
Wuhan Asia Heart Hospital
Responsible party
Litao Zhang, MD (Manager of anticoagulation clinic, Wuhan Asia Heart Hospital) — Principal investigator
First posted
Aug 29, 2017
Start date
Sep 1, 2017
Primary completion
Mar 1, 2019
Completion
Mar 8, 2019
Last update
Jun 19, 2019

Study contacts

Zhenlu Zhang, MD,PhD
study director · Wuhan Asia Heart Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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