Clinical trial NCT03454854: Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy
Official title: Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antithrombotic
Keywords: risk evaluation
individualized treatment
coronary artery disease
antithrombotic therapy
Chinese people
Application
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-03-06
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: adverse clinical events
timeFrame: 2 years
measure: BRAC 2-5 type bleeding
timeFrame: 2 years
Secondary outcomes:
measure: heart and cerebral vessels ischemia
timeFrame: 2 years
measure: readmission
timeFrame: 2 years
measure: angina recurrence
timeFrame: 2 years
measure: treatment discontinuation
timeFrame: 2 years
measure: drug-related events
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Jiyan Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: