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