NCT03380481

Brief Summary

Stroke is the first most common cause of death in China and one of the major causes of functional disability in the adult population.The burden of stoke is significantly increased in China in recent years. In order to investigate the prognosis of stroke, with diagnostic and treatment information of traditional Chinese medicine (TCM), and assess the effectiveness and safety of TCM for stroke in southern China, the investigators will conduct this multicenter prospective registry study in southern China. This study will recruit 10,000 consecutive eligible patients with acute stroke from more than 50 hospitals. 24 months follow-up will be carried out on-site in hospitals and by telephone to track endpoint (including all-cause mortality, composite cerebrovascular and cardiovascular events at one and two year follow up, and neurological and functional assessments).

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 all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 8, 2018

Status Verified

March 1, 2018

Enrollment Period

3 years

First QC Date

December 13, 2017

Last Update Submit

March 7, 2018

Conditions

StrokeCerebral InfarctionTransient Ischemic AttackCerebral HemorrhageSubarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    12 months follow-up

  • Composite cerebrovascular and cardiovascular events

    Including stroke recurrence events,acute myocardial infarction and cardiac death

    12 months follow-up

Secondary Outcomes (11)

  • All-cause mortality

    24 months follow-up

  • Composite cerebrovascular and cardiovascular events

    24 months follow-up

  • Modified Rankin Scale(mRS)

    3 months follow-up

  • Barthel Index(BI)

    3 months follow-up

  • Mini-Mental State Examination(MMSE)

    3 months follow-up

  • +6 more secondary outcomes

Study Arms (1)

SECRETS-TCM

Stroke patients who treated by western medicine and/or traditional Chinese medicine in southern China

Other: observational only-no intervention

Interventions

observational only-no interventionOTHER

Observational only and no predesigned interventions in this study.

SECRETS-TCM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will be comprised of those who meet all inclusion criteria and no exclusion criteria. Study personnel will continuously screen eligible patients presenting to the hospitals until the sample size of 10000 is reached. This study will be conducted in more than 50 hopitals in southern China.

You may qualify if:

  • ≥18 years.
  • Patients within 14 days of onset of acute stroke (including acute cerebral infarction, transient ischemic attack, acute cerebral hemorrhage, acute subarachnoid hemorrhage).
  • The patient and/or guardian agree to participate in this study.

You may not qualify if:

  • Patients with silent cerebrovascular disease.
  • Patients with non-cerebrovascular disease events.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuyi Traditional Chinese Medicine Hospital of Jiangmen

Jiangmen, Guangdong, 529000, China

RECRUITING

MeSH Terms

Conditions

StrokeCerebral InfarctionIschemic Attack, TransientCerebral HemorrhageSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InfarctionBrain IschemiaInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisIntracranial HemorrhagesHemorrhage

Study Officials

  • Yefeng Cai, M.D.,Ph D

    Guangdong Provincial Hospital of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yefeng Cai, M.D.,PhD

CONTACT

+86-13631333842caiyefeng@126.com

Xinfeng Guo, PhD

CONTACT

+86-13678906862guoxinfeng@gzucm.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Encephalopathy Center of Guangdong Provincial Hospital of Chinese Medcicine

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 21, 2017

Study Start

January 15, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 8, 2018

Record last verified: 2018-03

Locations

CN(1)