Back to resultsEffectiveness of the Application(APP) on Individualized Antithrombotic Therapy (APP)
Primary Purpose
Antithrombotic
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intelligent terminal APP
Sponsored by
About this trial
This is an interventional treatment trial for Antithrombotic focused on measuring risk evaluation, individualized treatment, coronary artery disease, antithrombotic therapy, Chinese people, Application
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)
Sites / Locations
- Guangdong General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
APP-assisted anti-thrombotic therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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
BRAC 2-5 type bleeding
defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
Secondary Outcome Measures
heart and cerebral vessels ischemia
adeverse events of vascular death, myocardial infarction and stroke
readmission
incidence of readmission during 2-year follow-up
angina recurrence
incidence of angina recurrence during 2-year follow-up
treatment discontinuation
incidence of treatment discontinuation during 2-year follow-up
drug-related events
incidence of drug-related adverse reaction during 2-year follow-up
Full Information
NCT ID
NCT03454854
First Posted
February 27, 2018
Last Updated
May 22, 2018
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03454854
Brief Title
Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy
Acronym
APP
Official Title
Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 20, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antithrombotic
Keywords
risk evaluation, individualized treatment, coronary artery disease, antithrombotic therapy, Chinese people, Application
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
APP-assisted anti-thrombotic therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
intelligent terminal APP
Intervention Description
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.
Primary Outcome Measure Information:
Title
adverse clinical events
Description
net adverse clinical events during 2 years follow-up, including death, myocardial infarction, stroke, ischemia induced target vessel revascularization, BARC type 2-5 bleeding
Time Frame
2 years
Title
BRAC 2-5 type bleeding
Description
defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）
Time Frame
2 years
Secondary Outcome Measure Information:
Title
heart and cerebral vessels ischemia
Description
adeverse events of vascular death, myocardial infarction and stroke
Time Frame
2 years
Title
readmission
Description
incidence of readmission during 2-year follow-up
Time Frame
2 years
Title
angina recurrence
Description
incidence of angina recurrence during 2-year follow-up
Time Frame
2 years
Title
treatment discontinuation
Description
incidence of treatment discontinuation during 2-year follow-up
Time Frame
2 years
Title
drug-related events
Description
incidence of drug-related adverse reaction during 2-year follow-up
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyan Chen, M.D.
Phone
02083827812
Email
chenjiyandr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, M.D.
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, M.D.
Phone
02083827812
Email
chenjiyandr@126.com
First Name & Middle Initial & Last Name & Degree
Jiyan Chen, M.D.
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy
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