Clinical Trial: Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Azelnidipine vs Perindopril and Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients (APPROVE):Multi-center R

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 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


Detailed Summary:

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 automa
Sponsor: Yining Huang

Current Primary Outcome: Cerebral Small Vessel Disease progressing [ Time Frame: two years ]

Area of WML increase more than 4% or Number of CMBs increase more than 2


Original Primary Outcome: white matter lesion [ Time Frame: two years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Peking University First Hospital

Dates:
Date Received: March 24, 2013
Date Started: May 2012
Date Completion: December 2016
Last Updated: October 22, 2015
Last Verified: October 2015