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| ID | Type | Description | Link |
|---|---|---|---|
| APPROVE | Registry Identifier | Yining Huang |
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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 control of blood pressure in slowing down the small vessel disease.
C drugs of Calcium Channel Blocker(CCB) and Angiotensin-Converting Enzyme Inhibitor(ACEI) have no significant difference in lowing the blood pressure and variability of blood pressure
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 separately for treatment. At the same time, given intensive or regular controlling of the blood pressure by stratified random. In the regular controlling group, the BP should be in the range of 130-139 mmHg and in the intensive controlling group, the BP should be below 130 mmHg. To the acute ischemic stroke patients who were accord with the lacunar infarction syndrome, it is rule to do the examination for exclusive selection of exclusion of hemodynamic dysfunction due to the artery stenosis ( stenosis >50%, the examination of intracranial artery was by the methods of Transcranial Doppler (TCD)/Magnetic Resonance Angiography(MRA)/Computed Tomographic Angiography(CTA)/Digital Subtraction Angiography(DSA), the examination of carotid artery was by the methods of colorful ultrasound / MRA/ CTA/ DSA ) at the baseline.
It should be proved of lacunar infarction by brain imaging. All patients had a MRI scan at the baseline and the beginning of the research, including T1-Weighted Imaging(T1W1),T2-Weighted Imaging(T2WI), T2-FLAIR, Diffusion-Weighted Imaging(DWI), Gradient-Recalled Echo(GRE) T2*, the Perfusion-Weighted Imaging(PWI) would complete conditionally (100 cases). The details should be followed by the instruction in the appendix.
Research about the variability of blood pressure: all patients show complete the examination of 24-hour blood-pressure monitor (at the baseline, the first month after the beginning, every three months and the end of the research), complete the head-up tilt test if conditionally ( at the baseline, each 3 months later and the end of the research ) The automatic regulation function of the small vessel should be evaluated if conditionally (the C02 reaction, TCD head-up tilt) and also the function of endothelium-derived relaxing of the brachial artery (at the baseline, each 3 months later and the end of the research) The reservation of the blood was for further research on genetic study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Azelnidipine/Perindopril | Sham Comparator | Systole blood pressure controlled between 130 mmHg~140 mmHg(with or without hydrochlorothiazide). |
|
| Intensive Azelnidipine/Perindopril | Experimental | Systole blood pressure controlled below 130 mmHg(with or without hydrochlorothiazide). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azelnidipine | Drug | 8mg or 16mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Small Vessel Disease progressing | Area of WML increase more than 4% or Number of CMBs increase more than 2 | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peking University First Hospital | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Yining Huang, M.D. | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D059345 | Cerebral Small Vessel Diseases |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C061679 | azelnidipine |
| D020913 | Perindopril |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Perindopril | Drug | 4mg or 8mg |
|
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| hydrochlorothiazide | Drug | 12.5mg or 25mg |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |