Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease

Conditions
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Antithrombotic

Intervention / Treatment
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* Device: intelligent terminal APP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: inability to obtain consent from participants; unable to record the medical data through terminal applications(APP)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APP-assisted anti-thrombotic therapy<br>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. | Device: intelligent terminal APP<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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） | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart and cerebral vessels ischemia | adeverse events of vascular death, myocardial infarction and stroke | 2 years | 
| readmission | incidence of readmission during 2-year follow-up | 2 years | 
| angina recurrence | incidence of angina recurrence during 2-year follow-up | 2 years | 
| treatment discontinuation | incidence of treatment discontinuation during 2-year follow-up | 2 years | 
| drug-related events | incidence of drug-related adverse reaction during 2-year follow-up | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk evaluation, individualized treatment, coronary artery disease, antithrombotic therapy, Chinese people, Application