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Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy (APP)

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ClinicalTrials.gov Identifier: NCT03454854
Recruitment Status : Unknown
Verified May 2018 by Jiyan Chen, Guangdong Provincial People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 6, 2018
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Jiyan Chen, Guangdong Provincial People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Antithrombotic Device: intelligent terminal APP Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of the Application on Individualized Antithrombotic Therapy in Chinese Patients With Coronary Artery Disease
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 20, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: APP-assisted anti-thrombotic therapy
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. adverse clinical events [ Time Frame: 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

  2. BRAC 2-5 type bleeding [ Time Frame: 2 years ]
    defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium（BRAC）


Secondary Outcome Measures :
  1. heart and cerebral vessels ischemia [ Time Frame: 2 years ]
    adeverse events of vascular death, myocardial infarction and stroke

  2. readmission [ Time Frame: 2 years ]
    incidence of readmission during 2-year follow-up

  3. angina recurrence [ Time Frame: 2 years ]
    incidence of angina recurrence during 2-year follow-up

  4. treatment discontinuation [ Time Frame: 2 years ]
    incidence of treatment discontinuation during 2-year follow-up

  5. drug-related events [ Time Frame: 2 years ]
    incidence of drug-related adverse reaction during 2-year follow-up


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03454854


Contacts
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Contact: Jiyan Chen, M.D. 02083827812 chenjiyandr@126.com

Locations
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China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Jiyan Chen, M.D.    02083827812    chenjiyandr@126.com   
Principal Investigator: Jiyan Chen, M.D.         
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Jiyan Chen, M.D. Guangdong Provincial People's Hospital
More Information
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Responsible Party: Jiyan Chen, professor, Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03454854    
Other Study ID Numbers: GDCR2017144H
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiyan Chen, Guangdong Provincial People's Hospital:
risk evaluation
individualized treatment
coronary artery disease
 antithrombotic therapy
Chinese people
Application
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases