Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy
- Conditions
- Antithrombotic
- Interventions
- Device: intelligent terminal APP
- Registration Number
- NCT03454854
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 10000
- 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.
- inability to obtain consent from participants;
- unable to record the medical data through terminal applications(APP)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description APP-assisted anti-thrombotic therapy intelligent terminal APP 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.
- Primary Outcome Measures
Name Time Method adverse clinical events 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 2 years defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
- Secondary Outcome Measures
Name Time Method heart and cerebral vessels ischemia 2 years adeverse events of vascular death, myocardial infarction and stroke
readmission 2 years incidence of readmission during 2-year follow-up
angina recurrence 2 years incidence of angina recurrence during 2-year follow-up
treatment discontinuation 2 years incidence of treatment discontinuation during 2-year follow-up
drug-related events 2 years incidence of drug-related adverse reaction during 2-year follow-up
Trial Locations
- Locations (1)
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China