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

NCT01819441 | Unknown Phase 4 DMC

• 2 other identifiers: Peking UniversityAPPROVE
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Small Vessel Diseases

Keywords

cerebral small Vessel diseases, blood pressure,CCB, ACEI

Outcome Measures

Primary Outcomes (1)

• Cerebral Small Vessel Disease progressing

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

  two years

Study Arms (2)

Normal Azelnidipine/Perindopril

SHAM COMPARATOR

Systole blood pressure controlled between 130 mmHg\~140 mmHg(with or without hydrochlorothiazide).

Drug: Azelnidipine; Drug: Perindopril; Drug: hydrochlorothiazide

Intensive Azelnidipine/Perindopril

EXPERIMENTAL

Systole blood pressure controlled below 130 mmHg(with or without hydrochlorothiazide).

Drug: Azelnidipine; Drug: Perindopril; Drug: hydrochlorothiazide

Interventions

Azelnidipine DRUG

8mg or 16mg

Also known as: BeiQi

Intensive Azelnidipine/Perindopril; Normal Azelnidipine/Perindopril

Perindopril DRUG

4mg or 8mg

Also known as: YiTai

Intensive Azelnidipine/Perindopril; Normal Azelnidipine/Perindopril

hydrochlorothiazide DRUG

12.5mg or 25mg

Intensive Azelnidipine/Perindopril; Normal Azelnidipine/Perindopril

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yining Huang: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

azelnidipine; Perindopril; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides

Study Officials

• Yining Huang, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peking University First Hospital

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chairman

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: March 27, 2013
• Study Start: May 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 23, 2015

Record last verified: 2015-10

Locations

CN (1)