Clinical trial NCT03264937: Social-software iMproving wARfarin Therapy
Official title: Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anticoagulants Causing Adverse Effects in Therapeutic Use
Patient Compliance
Keywords: TTR
INR
Warfarin
social software
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 735
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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 contraindication described in the warfarin package insert;
* be willing to be randomized;
* sign the informed consent form;
* not be enrolled in another randomized clinical trial that involves a drug or device intervention.

Exclusion Criteria:

* subject has had an intracranial haemorrhage, subarachnoid haemorrhage, hemorrhagic stroke, or any other absolute/major contraindication 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

Primary outcomes:
measure: Time to First Event
timeFrame: Up to 18 months
Secondary outcomes:
measure: Time in therapeutic range
timeFrame: Up to 18 months
measure: Individual variation of International Normalized Ratio (INR)
timeFrame: Up to 18 months
measure: Times of extremely high International Normalized Ratio (INR) values
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WAHH
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Zhenlu Zhang, MD,PhD
role: STUDY_DIRECTOR
References: