Condition category
Circulatory System
Date applied
30/03/2007
Date assigned
26/04/2007
Last edited
26/04/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wang Yongjun

ORCID ID

Contact details

Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
Beijing
100050
China
yongjunw@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

STOP

Study hypothesis

The secondary prevention collaborative system is hospitalised; for doctors, it can increase the coincidence with the therapeutic regime and for patients, it can improve the compliance to the risk factor controls.

Ethics approval

Approval gained from the Beijing Tiantan Hospital Capital Medical University Ethics Board on the January 19, 2007.

Study design

The trial is a prospective cohort study. Because the staff take turns to care for the patients in different wards, it is impossible to randomise grouping.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Ischaemic stroke and Transient Ischaemic Attack (TIA)

Intervention

The conception of this project is to organise the effective stroke secondary prevention program, which is initiated at hospitalisation, into the whole course of stroke care, thus improving the prophylaxis of inpatients with ischaemic stroke or TIA, on medical compliance, confidence, preventive efficacy.

There are three treatments:
1. The medical treatment includes drug treatments of hypertension, dyslipoidemia, carotid stenosis, and anti-platelet agents
2. The surgical treatment includes carotid endarterctomy, carotid angioplasty and stent
3. Lifestyle modifications comprise of stopping smoking, weight control and public education

The program is practiced on all patients who have a probability of scleratheromic stroke.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. The coincidence with the therapeutic regimen
2. The compliance to the risk factor controls

Secondary outcome measures

The reoccurrence rate of vascular issues.

Overall trial start date

01/10/2006

Overall trial end date

01/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age equal to or older than 18 years
2. Ischaemic event (infarction/Transient Ischaemic Attack [TIA]) within two weeks
3. Diagnosis of infarction or TIA
Infarction:
a. sudden or rapid onset of focal ischaemic neurological impairments by all kinds of reasons
b. the impairments last more than 24 hours
TIA:
a. sudden or rapid onset of focal ischaemic neurological impairments by all kinds of reasons
b. the impairments are within 24 hours (the diagnosis could be made if the patient have one of the symptoms: amaurosis fugax, dysphasia, movement disorder such as weakness or clumsiness; but such symptoms as diplopia, scintillation, scotosis, vertigo, memory disorder and ataxia cannot support the diagnoses; the symptoms that may be caused by migraine are ruled out)
4. No matter which one it is, all have either a Computed Tomography (CT) or a Magnetic Resonance Imaging (MRI) scan, to preclude haemorrhage or other non-ischaemic nerve system diseases
5. All the diagnoses have been confirmed and registered by the research centre neurologist
6. Patient resident in Beijing for at least one year
7. Patient consents to follow up for at least one year
8. Mechanism of the event is probably infarction/TIA due to artery scleratheroma
9. More than one modifiable risk factors of Cardiovascular Disease (CVD)
10. The case collected in each research centre should be consecutive. Even the patients who qualified but reject to join in, should also be added in the sum and registered with the basic items such as name, sex, age

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

1600

Participant exclusion criteria

1. Pregnancy
2. Silent infarction without symptoms or focal signs
3. Venous infarction
4. Other causes of ischaemic stroke but not scleratheromic. For example, cardiac resource, hyper-coagulation, dissection, vasculitis, medical resource such as the complications of carotid endarterctomy or angiography, traumatic resource, aura migraine, epilepsy, other non-ischaemic stroke
5. Reject to join in the study
6. Event episode concomitant with cardiac disease, cardiac insufficiency, hepatosis, renal inadequacy, respiratory failure, malignant tumour etc., and anticipate not to accomplish the one year-follow up
7. Glasgow Coma Score (GCS) less than four

Recruitment start date

01/10/2006

Recruitment end date

01/06/2008

Locations

Countries of recruitment

China

Trial participating centre

Beijing Tiantan Hospital
Beijing
100050
China

Sponsor information

Organisation

Beijing Tiantan Hospital (China)

Sponsor details

c/o Professor Wang Yongjun
Tiantan Xili 6
Chongwen District
Beijing
100050
China
yongjunw@hotmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Beijing Municipal Science & Technology Commission (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes