Cerebral Small Vessel DiseasesPhase 4APPROVENCT01819441
Stratification of Blood Pressure Control Against Progress of Cerebral Small Vessel Diseases in Poststroke Patients
A Phase 4 study testing Azelnidipine, Perindopril and hydrochlorothiazide in people with Cerebral Small Vessel Diseases, run by Yining Huang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- Azelnidipine, Perindopril and hydrochlorothiazide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Peking University First Hospital contact
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yining Huang, ynhuang@sina.com
About this study
Official title: 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
- 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
Read the 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.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- Azelnidipine, Perindopril, hydrochlorothiazide
- Keywords
- cerebral small Vessel diseases, blood pressure,CCB, ACEI
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzelnidipineDrug
Also called BeiQi
8mg or 16mg
PerindoprilDrug
Also called YiTai
4mg or 8mg
hydrochlorothiazideDrug
12.5mg or 25mg
| Study group | Role | What they receive |
|---|---|---|
| Normal Azelnidipine/Perindopril | Sham comparator | Systole blood pressure controlled between 130 mmHg~140 mmHg(with or without hydrochlorothiazide). Receives: Drug: Azelnidipine; Drug: Perindopril; Drug: hydrochlorothiazide |
| Intensive Azelnidipine/Perindopril | Experimental | Systole blood pressure controlled below 130 mmHg(with or without hydrochlorothiazide). Receives: Drug: Azelnidipine; Drug: Perindopril; Drug: hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Small Vessel Disease progressing
Area of WML increase more than 4% or Number of CMBs increase more than 2
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yining Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yining Huang, Peking University First Hospital
- Investigators
- Yining Huang, M.D., Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819441
- Sponsor's protocol ID
- Peking University
- Other IDs
- APPROVE
- Acronym
- APPROVE
- Status last verified
- Oct 2015
- First submitted
- 24 Mar 2013
- Last updated
- 23 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01819441
- Acronym / sponsor ID
- APPROVE / Peking University
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- cerebral small Vessel diseases, blood pressure,CCB, ACEI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Yining HuangUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Azelnidipine/Perindopril | Sham comparator | Drug: Azelnidipine, Drug: Perindopril, Drug: hydrochlorothiazideSystole blood pressure controlled between 130 mmHg~140 mmHg(with or without hydrochlorothiazide). |
| Intensive Azelnidipine/Perindopril | Experimental | Drug: Azelnidipine, Drug: Perindopril, Drug: hydrochlorothiazideSystole blood pressure controlled below 130 mmHg(with or without hydrochlorothiazide). |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzelnidipineAlso: BeiQi8mg or 16mg | Drug | Intensive Azelnidipine/Perindopril, Normal Azelnidipine/Perindopril |
| PerindoprilAlso: YiTai4mg or 8mg | Drug | Intensive Azelnidipine/Perindopril, Normal Azelnidipine/Perindopril |
| hydrochlorothiazide12.5mg or 25mg | Drug | Intensive Azelnidipine/Perindopril, Normal Azelnidipine/Perindopril |
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peking University First Hospital contact
Yining Huang, M.D. principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azelnidipine, Perindopril and hydrochlorothiazide in people with Cerebral Small Vessel Diseases, run by Yining Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peking University First Hospital, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Small Vessel Disease progressing (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.