Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients (APPROVE)

October 22, 2015 updated by: Yining Huang

Azelnidipine vs Perindopril and Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients (APPROVE):Multi-center Randomized Controlled Clinical Trial

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peking University First Hospital

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Normal Azelnidipine/Perindopril
Systole blood pressure controlled between 130 mmHg~140 mmHg(with or without hydrochlorothiazide).
Drug: Azelnidipine
8mg or 16mg
Other Names:
  • BeiQi
Drug: Perindopril
4mg or 8mg
Other Names:
  • YiTai
Drug: hydrochlorothiazide
12.5mg or 25mg
Experimental: Intensive Azelnidipine/Perindopril
Systole blood pressure controlled below 130 mmHg(with or without hydrochlorothiazide).
Drug: Azelnidipine
8mg or 16mg
Other Names:
  • BeiQi
Drug: Perindopril
4mg or 8mg
Other Names:
  • YiTai
Drug: hydrochlorothiazide
12.5mg or 25mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral Small Vessel Disease progressing
Time Frame: two years
Area of WML increase more than 4% or Number of CMBs increase more than 2
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yining Huang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 24, 2013

First Submitted That Met QC Criteria

March 24, 2013

First Posted (Estimate)

March 27, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2015

Last Update Submitted That Met QC Criteria

October 22, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Peking University
  • APPROVE (Registry Identifier: Yining Huang)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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