CClinicalTrials.gg
Status unknownNCT03454854APPUpdated May 24, 2018

Effectiveness of the Application(APP) on Individualized Antithrombotic Therapy

An interventional study of intelligent terminal APP in Antithrombotic, sponsored by Guangdong Provincial People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-24.

Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
10,000
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Antithrombotic

Keywords

  • risk evaluation
  • individualized treatment
  • coronary artery disease
  • antithrombotic therapy
  • Chinese people
  • Application
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • inability to obtain consent from participants;
  • unable to record the medical data through terminal applications(APP)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10,000 participants (estimated)

Study arms

  • 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

Interventions

  • Deviceintelligent 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

  2. BRAC 2-5 type bleeding

    defined as bleeding event graded 2 to 5 of Standardized bleeding definitions from the Bleeding Academic Research Consortium(BRAC)

    Time frame: 2 years

Secondary outcomes

  1. heart and cerebral vessels ischemia

    adeverse events of vascular death, myocardial infarction and stroke

    Time frame: 2 years

  2. readmission

    incidence of readmission during 2-year follow-up

    Time frame: 2 years

  3. angina recurrence

    incidence of angina recurrence during 2-year follow-up

    Time frame: 2 years

  4. treatment discontinuation

    incidence of treatment discontinuation during 2-year follow-up

    Time frame: 2 years

  5. drug-related events

    incidence of drug-related adverse reaction during 2-year follow-up

    Time frame: 2 years

06

Study locations

1 of 1 sites recruiting
  • Guangdong General Hospital
    Guangzhou, Guangdong, China
    • Jiyan Chen, M.D. · Contact · chenjiyandr@126.com · 02083827812
    • Jiyan Chen, M.D. · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT03454854
Lead sponsor
Guangdong Provincial People's Hospital
Responsible party
Jiyan Chen (professor, Guangdong Provincial People's Hospital) — Principal investigator
First posted
Mar 6, 2018
Start date
Nov 1, 2017
Primary completion
Dec 30, 2019 (estimated)
Completion
Dec 20, 2020 (estimated)
Last update
May 24, 2018

Study contacts

Jiyan Chen, M.D.
Contact
chenjiyandr@126.com
02083827812
Jiyan Chen, M.D.
principal investigator · Guangdong Provincial People's Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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