Status:
UNKNOWN
Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients
Lead Sponsor:
Yining Huang
Conditions:
Cerebral Small Vessel Diseases
Eligibility:
All Genders
40-85 years
Phase:
PHASE4
Brief Summary
A. the controlling of the blood pressure, especially the variation of blood pressure, can slow down the development of the small vessel disease. B intensive BP control is more effective than normal c...
Detailed Description
The selected patients were diagnosis of stroke caused by small vessel disease due to hypertension recently. The patients had been divided into two groups by random principle and given ACEI or CCB sep...
Eligibility Criteria
Inclusion
- Cerebral infarction within 10 days to 6 months.
- Clinical manifestation represented as lacunar infarction syndrome; without aphasia or disturbance of consciousness.
- Mini-Mental State Examination(MMSE)\>24 and modified Rankin Score(mRS)≤3.
- History of hypertension, and need to be treated with drugs; patient who had been diagnosis hypertension or the first time with the diagnosis of this disease after the guideline of China 2010 (measurement of the BP in the seated posture of the up arm after having a rest for 5 minutes and was taken for three times and calculated the average result, make sure the difference of BP between right and left arm are not beyond the criteria of 20 mmHg and the right arm for consistence. The patients have different BP between both sides which the difference beyond 20 mmHg need to exam for the stenosis of subclavian artery.
- MRI confirm the lesion for lacunar infarction and be responsible for the clinical symptom located in the region of perforating artery and the diameter of the lesion is less than 20mm.
- The examinations of carotid artery and intracranial artery have excluded hemodynamic abnormalities due to artery stenosis ( stenosis \>50%, the examination of intracranial artery was by the methods of TCD/ MRA/ CTA/ DSA, the examination of carotid artery was by the methods of colorful ultrasound / MRA/ CTA/ DSA ). The combination of thickness Intima media or plaque of the carotid artery without the hemodynamic dysfunction can be enrolled in this research.
- Informed consent was signed.
Exclusion
- Hypertension diffcult to control, instantly over 220/ 120 mmHg.
- History of atrial fibrillation (Paroxysmal or sustained).
- History of heart infarction within 6 months.
- Stenosis above 50% or hemodynamic dysfunction in carotid and intracranial artery after examination.
- Unknown caused of brain infarction, like dissection vascular, Moyamoya disease, vasculitis, hereditary small angiopathy ( eg,Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leucoencephalopathy(CADASIL), FABRY, mitochondrial encephalopathy).
- Severe liver and renal disease. the definition of sever liver disease was Alanine aminotransferase(ALT) or Aspartate aminotransferase(AST) 4 times than the normal level, or the total bilirubin above 20 mmol/L, or cirrhosis. the definition of sever renal disease was stenosis of renal artery and dysfunction of renal (clearance rate of creatinine \<60ml/min or serum creatinine \>265mmol/L).
- History of hemorrhage.
- Active bleeding disease or clear coagulation disorders.
- Malignant neoplasm.
- Pregnancy.
- Severe organic diseases, expected lifetime was shorter than 2 years.
- Conditions contraindicated for CCB or ACEI, such as hyperpotassaemia (serum potassium \>5.5mmol/L) or have the evidence proved allergic to both drugs.
- Eenrolled in another clinical trial in 30 days.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT01819441
Start Date
May 1 2012
End Date
December 1 2016
Last Update
October 23 2015
Active Locations (1)
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1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034