Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy

Antithrombotic Clinical Trial

— APP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03454854
• Other study ID #: GDCR2017144H
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: December 20, 2020

Study information

• Verified date: May 2018
• Source: Guangdong General Hospital
• Contact: Jiyan Chen, M.D.
• Phone: 02083827812
• Email: chenjiyandr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 20, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Antithrombotic
• Coronary Artery Disease

Intervention

Device:
• intelligent terminal APP
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.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	heart and cerebral vessels ischemia	adeverse events of vascular death, myocardial infarction and stroke	2 years
Secondary	readmission	incidence of readmission during 2-year follow-up	2 years
Secondary	angina recurrence	incidence of angina recurrence during 2-year follow-up	2 years
Secondary	treatment discontinuation	incidence of treatment discontinuation during 2-year follow-up	2 years
Secondary	drug-related events	incidence of drug-related adverse reaction during 2-year follow-up	2 years