NCT03454854

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

2.2 years

First QC Date

February 27, 2018

Last Update Submit

May 22, 2018

Conditions

Antithrombotic

Keywords

risk evaluationindividualized treatmentcoronary artery diseaseantithrombotic therapyChinese peopleApplication

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (5)

  • heart and cerebral vessels ischemia

    2 years

  • readmission

    2 years

  • angina recurrence

    2 years

  • treatment discontinuation

    2 years

  • drug-related events

    2 years

Study Arms (1)

APP-assisted anti-thrombotic therapy

EXPERIMENTAL

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

intelligent terminal APPDEVICE

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.

APP-assisted anti-thrombotic therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Jiyan Chen, M.D.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiyan Chen, M.D.

CONTACT

02083827812chenjiyandr@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 6, 2018

Study Start

November 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 20, 2020

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations

CN(1)