Clinical trial NCT02618265: Mobile Terminal Based Management of Stroke Secondary Prevention Adminstration Effect Research
Official title: Mobile Terminal Based Management and Platelet Reactivity Modified Drug Regulation of Stroke Secondary Prevention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
secondary prevention
platelet response polymorphism
mobile terminal
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: With high incidence, mortality, morbidity and recurrence rate，stroke has significant impact on national development strategies planning. Improving secondary prevention will strongly promote stroke management in the rapid developing phase of Chinese economy and expansion of health situation. At present lack of high-quality medical resources, low medical permeability cannot remedy extensive prevention failure of stroke. Mobile healthcare is easier to conduct and still in the early stage of explosive growth. This research group has established an open management platform of stroke prevention. And collaborate with Peking University Institute of Information Technology to develop a smart phone application which can be personalized medication reminder, record medication compliance, home blood pressure and blood glucose test results, also can provide doctor-patient communication platform and symptoms alarm. 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. Control group will be selected from the National Stroke data registration database platform and open platform for stroke prevention. Follow-up period is 2 years. Endpoint event is defined as stroke death or relapse. Primary measure outcomes are change of the stroke recurrence rate and mortality after secondary prevention.

Eligibility criteria: Inclusion Criteria:

* stroke

Exclusion Criteria:

* refusion in research

Primary outcomes:
measure: change of the stroke recurrence rate
timeFrame: 2 years stroke recurrence rate
Secondary outcomes:
measure: change of the stroke mortality
timeFrame: 2 years stroke mortality
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: PUTH
name: Jie Qiao
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.