AntithromboticAPPNCT03454854
Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy
A study testing intelligent terminal APP in people with Antithrombotic, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antithrombotic
- What is being tested?
- intelligent terminal APP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 20 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age≥18 years;
- clinical confirmed coronary heart disease. Including definite history of myocardial infarction, stable angina with exercise electrocardiography test(treadmill exercise) positive, unstable angina with electrocardiogram(ECG) ischemic changes or troponin positive, coronary angiography(CAG) hints at least one coronary artery stenoses over 50%, post-operative of percutaneous coronary intervention(PCI) or coronary artery bypass grafting(CABG);
- Be receiving anti-thrombotic therapy;
- Be voluntary to participate in the study., and sign informed consent form.
Who cannot join
- inability to obtain consent from participants;
- unable to record the medical data through terminal applications(APP)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong
Jiyan Chen, M.D., 02083827812, chenjiyandr@126.com
Jiyan Chen, M.D.
About this study
Official title: Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.
Read the detailed description
1.1.Develop and optimize antithrombotic therapy network data platform and thrombotic risk evaluate the intelligent terminal APP, establish a new pattern based on dynamic risk evaluation and event-triggered response, settle the conundrum in clinical practice about antithrombotic therapy such as poor compliance, lag and unreasonable in drug adjustment.
1.2.Settle the technical problem that intelligent terminal APP code isn't compatible with most tablet PCs and smartphones.
1.3.Impel the data platform to render and integrate with the daily medical system, enhance its accuracy, compatibility, privacy, and quality standard.
1.4.Promote the new pattern of anti-thrombotic management by large sample's cohort study, increase the patients' compliance, reduce the readmission rate and adverse event rate of heart and cerebral vessels.
- Conditions
- Antithrombotic
- Being tested
- intelligent terminal APP
- Keywords
- risk evaluation, individualized treatment, coronary artery disease, antithrombotic therapy, Chinese people, Application
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intelligent terminal APPDevice
Applications(APP) support patients to upload the primary data contain pictures and wearable devices data. When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor. Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc.
| Study group | Role | What they receive |
|---|---|---|
| APP-assisted anti-thrombotic therapy | Experimental | Intelligent response system:real-time receiving data or events that doctor or patient terminal upload,then spontaneously evaluate the thrombosis and bleeding risk based on code of point built-in,respectively send messages to doctor and patient after this, then doctors direct the patients to adjust treatment schedule.Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal APP, establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study. Receives: Device: intelligent terminal APP |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse clinical events
net adverse clinical events during 2 years follow-up, including death, myocardial infarction, stroke, ischemia induced target vessel revascularization, BARC type 2-5 bleeding
Measured: 2 years
BRAC 2-5 type bleeding
defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
Measured: 2 years
Secondary outcomes (5)
heart and cerebral vessels ischemia
adeverse events of vascular death, myocardial infarction and stroke
Measured: 2 years
readmission
incidence of readmission during 2-year follow-up
Measured: 2 years
angina recurrence
incidence of angina recurrence during 2-year follow-up
Measured: 2 years
treatment discontinuation
incidence of treatment discontinuation during 2-year follow-up
Measured: 2 years
drug-related events
incidence of drug-related adverse reaction during 2-year follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Nov 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion20 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AntithromboticStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, M.D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454854
- Sponsor's protocol ID
- GDCR2017144H
- Acronym
- APP
- Status last verified
- May 2018
- First submitted
- 27 Feb 2018
- Last updated
- 24 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT03454854
- Acronym / sponsor ID
- APP / GDCR2017144H
- Conditions
- Antithrombotic
- Keywords
- risk evaluation, individualized treatment, coronary artery disease, antithrombotic therapy, Chinese people, Application
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 6 Mar 2018 (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.
Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal application(APP), establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study.
Detailed description
1.1.Develop and optimize antithrombotic therapy network data platform and thrombotic risk evaluate the intelligent terminal APP, establish a new pattern based on dynamic risk evaluation and event-triggered response, settle the conundrum in clinical practice about antithrombotic therapy such as poor compliance, lag and unreasonable in drug adjustment.
1.2.Settle the technical problem that intelligent terminal APP code isn't compatible with most tablet PCs and smartphones.
1.3.Impel the data platform to render and integrate with the daily medical system, enhance its accuracy, compatibility, privacy, and quality standard.
1.4.Promote the new pattern of anti-thrombotic management by large sample's cohort study, increase the patients' compliance, reduce the readmission rate and adverse event rate of heart and cerebral vessels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APP-assisted anti-thrombotic therapy | Experimental | Device: intelligent terminal APPIntelligent response system:real-time receiving data or events that doctor or patient terminal upload,then spontaneously evaluate the thrombosis and bleeding risk based on code of point built-in,respectively send messages to doctor and patient after this, then doctors direct the patients to adjust treatment schedule.Develop an exemplary anti-thrombotic therapy network data platform and a intelligent terminal APP, establish an new pattern used in long-time anti-thrombotic management based on dynamic risk evaluation, and promoted and verified by 10 thousands large sample's cohort study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age≥18 years;
- clinical confirmed coronary heart disease. Including definite history of myocardial infarction, stable angina with exercise electrocardiography test(treadmill exercise) positive, unstable angina with electrocardiogram(ECG) ischemic changes or troponin positive, coronary angiography(CAG) hints at least one coronary artery stenoses over 50%, post-operative of percutaneous coronary intervention(PCI) or coronary artery bypass grafting(CABG);
- Be receiving anti-thrombotic therapy;
- Be voluntary to participate in the study., and sign informed consent form.
Key exclusion criteria (2 listed)
- inability to obtain consent from participants;
- unable to record the medical data through terminal applications(APP)
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 |
|---|---|---|
| intelligent terminal APPApplications(APP) support patients to upload the primary data contain pictures and wearable devices data. When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor. Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc. | Device | APP-assisted anti-thrombotic therapy |
Primary outcome
adverse clinical events
Time frame: 2 years
net adverse clinical events during 2 years follow-up, including death, myocardial infarction, stroke, ischemia induced target vessel revascularization, BARC type 2-5 bleeding
BRAC 2-5 type bleeding
Time frame: 2 years
defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
5 secondary outcomes
heart and cerebral vessels ischemia
Time frame: 2 years
readmission
Time frame: 2 years
angina recurrence
Time frame: 2 years
treatment discontinuation
Time frame: 2 years
drug-related events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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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.
Jiyan Chen, M.D. principal investigator
Guangdong Provincial People's 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 intelligent terminal APP in people with Antithrombotic, run by Guangdong Provincial People's 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 4 inclusion and 2 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 24 May 2018. 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?
Contact Jiyan Chen, M.D. (02083827812, chenjiyandr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse clinical events (time frame: 2 years). 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 24 May 2018.