NCT02618265

Brief Summary

The investigators want to verify whether mobile application based on stroke strengthen prevention management is more effective than traditional management model or open stroke management platform. Whole blood-impedance based platelet aggregation(WBA) method and VerifyNow detected by aspirin or clopidogrel responsiveness will provide individualized anti-platelet drug selection. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.

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
400

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable stroke

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

First Submitted

Initial submission to the registry

September 16, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 1, 2015

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

September 16, 2015

Last Update Submit

November 27, 2015

Conditions

Stroke

Keywords

strokesecondary preventionplatelet response polymorphismmobile terminal

Outcome Measures

Primary Outcomes (1)

  • change of the stroke recurrence rate

    After secondary prevention

    2 years stroke recurrence rate

Secondary Outcomes (1)

  • change of the stroke mortality

    2 years stroke mortality

Study Arms (3)

Mobile terminal

EXPERIMENTAL

Stroke received mobile terminal management for secondary prevention administration, as the same time platelet reactivity modified drug selection was performed. Mobile application management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.

Procedure: Mobile terminal

traditional management

ACTIVE COMPARATOR

Stroke received traditional management for secondary prevention administration

Procedure: traditional management

website platform management

ACTIVE COMPARATOR

Stroke received website platform management for secondary prevention administration. Website platform management conducts the control and regulation for anti hypertension, statin and antiplatelet therapy to increasing drug compliance.

Procedure: website platform management

Interventions

Mobile terminalPROCEDURE

multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment

Also known as: Mobile Application
Mobile terminal
traditional managementPROCEDURE

aspirin or clopidogrel monotherapy or double treatment for

Also known as: traditional second prevention
traditional management
website platform managementPROCEDURE

second prevention based on website platform management

website platform management

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stroke

You may not qualify if:

  • refusion in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

  • Zhang Y, Fan D, Qiao S, Hu H. Verifynow P2Y12 PRU-Guided Modification of Clopidogrel for Prevention of Recurrent Ischemic Stroke: A Real-World Prospective Cohort Study. Neurol Ther. 2022 Dec;11(4):1749-1766. doi: 10.1007/s40120-022-00406-z. Epub 2022 Sep 26.

    PMID: 36163415DERIVED

  • Zhang Y, Fan D, Ji H, Qiao S, Li X. Treatment Adherence and Secondary Prevention of Ischemic Stroke Among Discharged Patients Using Mobile Phone- and WeChat-Based Improvement Services: Cohort Study. JMIR Mhealth Uhealth. 2020 Apr 15;8(4):e16496. doi: 10.2196/16496.

    PMID: 32293574DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Jie Qiao

    PUTH

    STUDY DIRECTOR

Central Study Contacts

Dongsheng Fan

CONTACT

+861082265032dsfan@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman of Neurology Department

Study Record Dates

First Submitted

September 16, 2015

First Posted

December 1, 2015

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2018

Last Updated

December 1, 2015

Record last verified: 2015-11

Locations

CN(1)