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STroke inpatient secOndary Prevention: current status and continuous care improvement
ISRCTN ISRCTN17207064
DOI 10.1186/ISRCTN17207064
ClinicalTrials.gov identifier
EudraCT number
Public title STroke inpatient secOndary Prevention: current status and continuous care improvement
Scientific title
Acronym STOP
Serial number at source 1
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.
Lay summary
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.
Countries of recruitment China
Disease/condition/study domain Ischaemic stroke and Transient Ischaemic Attack (TIA)
Participants - 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
Participants - 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
Anticipated start date 01/10/2006
Anticipated end date 01/06/2008
Status of trial Completed
Patient information material
Target number of participants 1600
Interventions 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.
Primary outcome measure(s) 1. The coincidence with the therapeutic regimen
2. The compliance to the risk factor controls
Secondary outcome measure(s) The reoccurrence rate of vascular issues.
Sources of funding Beijing Municipal Science & Technology Commission (China)
Trial website
Publications
Contact name Prof  Wang  Yongjun
  Address Beijing Tiantan Hospital
Tiantan Xili 6
Chongwen District
  City/town Beijing
  Zip/Postcode 100050
  Country China
  Email yongjunw@hotmail.com
Sponsor Beijing Tiantan Hospital (China)
  Address c/o Professor Wang Yongjun
Tiantan Xili 6
Chongwen District
  City/town Beijing
  Zip/Postcode 100050
  Country China
  Email yongjunw@hotmail.com
Date applied 30/03/2007
Last edited 26/04/2007
Date ISRCTN assigned 26/04/2007
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