Anticoagulants Causing Adverse Effects in Therapeutic UseSMARTNCT03264937
Social-software iMproving wARfarin Therapy
A study testing Social-software management in people with Anticoagulants Causing Adverse Effects in Therapeutic Use and Patient Compliance, run by Wuhan Asia Heart Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anticoagulants Causing Adverse Effects in Therapeutic Use, Patient Compliance
- What is being tested?
- Social-software management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 735 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 8 Mar 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
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.
- Being tested
- Social-software management
- Keywords
- TTR, INR, Warfarin, social software
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social-software managementBehavioural
Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Social-software management group | Experimental | 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. Receives: Behavioral: Social-software management |
| Routine management group | No intervention | This is the control group, Warfarin therapy was managed via traditional style without social software intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Event
Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
Measured: Up to 18 months
Secondary outcomes (3)
Time in therapeutic range
Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio
Measured: Up to 18 months
Individual variation of International Normalized Ratio (INR)
Standard deviation (SD) of individual INR results
Measured: Up to 18 months
Times of extremely high International Normalized Ratio (INR) values
Times of INR results above 4.0; Times of INR results above 12.0
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Mar 2019
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticoagulants Causing Adverse Effects in Therapeutic UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 735 participants (actual)
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
- Investigators
- Zhenlu Zhang, MD,PhD, Study director, Wuhan Asia Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264937
- Sponsor's protocol ID
- 2017-P-033
- Acronym
- SMART
- Status last verified
- Jun 2019
- First submitted
- 22 Aug 2017
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are going to make individual participant data (IPD) available to other researchers after our paper published
Publications
Zhang L, Li S, Li Z, Yu D, Wu H, Hua B, Xie L, Yuan X, Li Y, Zhang Z, Long Y. Social App to Improve Warfarin Therapy in Post-MHVR Chinese Patients: A Randomized Controlled Trial. Cardiovasc Ther. 2023 Jan 14;2023:2342111. doi: 10.1155/2023/2342111. eCollection 2023.
PubMed 36714197
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of Social-software Improving Warfarin Therapy in Patients With Mechanical Heart Valve Replacement
- ClinicalTrials.gov ID
- NCT03264937
- Acronym / sponsor ID
- SMART / 2017-P-033
- Keywords
- TTR, INR, Warfarin, social software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 735 participants (actual)
- Lead sponsor
- Wuhan Asia Heart HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 29 Aug 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Social-software management group | Experimental | Behavioral: Social-software managementWe 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. |
| Routine management group | No intervention | –This is the control group, Warfarin therapy was managed via traditional style without social software intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Social-software managementUsing Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement. | Behavioural | Social-software management group |
Primary outcome
Time to First Event
Time frame: Up to 18 months
Thrombotic events, such as Valve thrombosis, Stroke, Peripheral embolism; Major bleeding, such as cerebral hemorrhage，gastrointestinal bleeding etc.
3 secondary outcomes
Time in therapeutic range
Time frame: Up to 18 months
Individual variation of International Normalized Ratio (INR)
Time frame: Up to 18 months
Times of extremely high International Normalized Ratio (INR) values
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
- Derived from this study: PubMed 36714197Zhang L, Li S, Li Z, Yu D, Wu H, Hua B, Xie L, Yuan X, Li Y, Zhang Z, Long Y. Social App to Improve Warfarin Therapy in Post-MHVR Chinese Patients: A Randomized Controlled Trial. Cardiovasc Ther. 2023 Jan 14;2023:2342111. doi: 10.1155/2023/2342111. eCollection 2023.
- Individual participant dataSharing planned: Yes. We are going to make individual participant data (IPD) available to other researchers after our paper published
Related trials for Anticoagulants Causing Adverse Effects in Therapeutic Use
RecruitingObservational study
International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants
Antiphospholipid Syndrome, Thrombosis
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.
Zhenlu Zhang, MD,PhD study director
Wuhan Asia Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social-software management in people with Anticoagulants Causing Adverse Effects in Therapeutic Use and Patient Compliance, 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 8 inclusion and 4 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 19 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to First Event (time frame: Up to 18 months). 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 NCT03264937, which also lists 1 linked publication.
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 19 Jun 2019; AzTrials last refreshed its copy on 29 Oct 2026.