Blood Pressure VariabilityNCT01665235
Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis
A study testing Amlodipine, ACEI / ARB and Aspirin or Clopidogrel in people with Blood Pressure Variability and Intracranial Artery Stenosis, run by RenJi Hospital at 1 site in China.
Trial summary
Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Blood Pressure Variability, Intracranial Artery Stenosis
- What is being tested?
- Amlodipine, ACEI / ARB and Aspirin or Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Aug 2012to Aug 2014
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age : ≥ 18 years of age , ≤ 75 years old
- with intracranial artery stenosis in ischemic stroke
- the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference
- the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis
- MRS score ≤ 3 points
Who cannot join
- vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke
- associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners
- severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%
- With extracranial artery stenosis, especially carotid and vertebral artery stenosis .
- patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy
- Incomplete clinical data collection in patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
RenJi Hospital
Shanghai, Shanghai Municipality, 200127
Guowen Shi, MD
About this study
Official title: The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis
Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis
Read the detailed description
Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .
- Being tested
- Amlodipine, ACEI / ARB, Aspirin or Clopidogrel, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
ACEI / ARBDrug
ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
Aspirin or ClopidogrelDrug
aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)
AtorvastatinDrug
Atorvastatin 10 - 40mg / d ( statin therapy)
| Study group | Role | What they receive |
|---|---|---|
| amlodipine | Active comparator | The amlodipine - based antihypertensive treatment group (you can add a diuretic or other ) Receives: Drug: Amlodipine; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin |
| ACEI / ARB | Experimental | ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other) Receives: Drug: ACEI / ARB; Drug: Aspirin or Clopidogrel; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of stroke in a follow-up period
Measured: one year
Secondary outcomes (4)
blood pressure during the compliance status in a follow-up
Measured: one year
patients with blood pressure variability in a follow-up
Measured: one year
Changes in intracranial arterial stenosis and stiffness before and after the follow-up
Measured: one year
Other vascular events ( acute ischemic heart disease or vascular death )
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure VariabilityStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Guowen, RenJi Hospital
- Investigators
- Guowen Shi, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665235
- Sponsor's protocol ID
- RenJiH-20120804
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Study Between Blood Pressure Variability and the Prognosis of Ischemic Stroke With Intracranial Artery Stenosis
- ClinicalTrials.gov ID
- NCT01665235
- Acronym / sponsor ID
- RenJiH-20120804
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 15 Aug 2012 (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.
Correlation study about Blood Pressure Variability and the prognosis of ischemic stroke with intracranial artery stenosis
Detailed description
Extracranial atherosclerotic stenosis is the main reason for the European and American white ischemic stroke and transient ischemic attack,while Atherosclerotic intracranial arterial stenosis is an important reason for Asian patients with stroke ,accounting for the 33% to 51% of a etiology ratio.The latest research suggests that varying degrees of blood pressure variability can affect the risk of stroke.This study observe the relationship between blood pressure variability and prognosis of ischemic stroke patients with intracranial arterial stenosis,with cranial magnetic resonance imaging (MRI + DWI),magnetic resonance angiography and Trans-cranial Doppler(TCD) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amlodipine | Active comparator | Drug: Amlodipine, Drug: Aspirin or Clopidogrel, Drug: AtorvastatinThe amlodipine - based antihypertensive treatment group (you can add a diuretic or other ) |
| ACEI / ARB | Experimental | Drug: ACEI / ARB, Drug: Aspirin or Clopidogrel, Drug: AtorvastatinACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age : ≥ 18 years of age , ≤ 75 years old
- with intracranial artery stenosis in ischemic stroke
- the diagnosis of ischemic cerebrovascular disease are in line with the diagnostic criteria developed by the Chinese Medical Association Fourth National Cerebrovascular Disease Conference
- the patient admitted to hospital receive at least one examination like cranial MRI + DWI, MRA and TCD examination, clearly associated with intracranial arterial stenosis
- MRS score ≤ 3 points
Key exclusion criteria (6 listed)
- vascular , cardiac , and unknown causes or other reasons lead to ischemic stroke
- associated with significant emotional disorders, cognitive impairment or other mental disorders can not be partners
- severe occlusion of Unilateral intracranial arteries ( over 90 % ) or bilateral stenosis more than 70%
- With extracranial artery stenosis, especially carotid and vertebral artery stenosis .
- patients with extracranial artery stenosis or patients previously done neck or intracranial artery balloon dilation , stent forming surgery or carotid endarterectomy
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 |
|---|---|---|
| AmlodipineThe amlodipine - based antihypertensive treatment group (you can add a diuretic or other ) | Drug | amlodipine |
| ACEI / ARBACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other) | Drug | ACEI / ARB |
| Aspirin or Clopidogrelaspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents) | Drug | ACEI / ARB, amlodipine |
| AtorvastatinAtorvastatin 10 - 40mg / d ( statin therapy) | Drug | ACEI / ARB, amlodipine |
Primary outcome
the incidence of stroke in a follow-up period
Time frame: one year
4 secondary outcomes
blood pressure during the compliance status in a follow-up
Time frame: one year
patients with blood pressure variability in a follow-up
Time frame: one year
Changes in intracranial arterial stenosis and stiffness before and after the follow-up
Time frame: one year
Other vascular events ( acute ischemic heart disease or vascular death )
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
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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.
Guowen Shi, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amlodipine, ACEI / ARB and Aspirin or Clopidogrel in people with Blood Pressure Variability and Intracranial Artery Stenosis, run by RenJi Hospital 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 5 inclusion and 6 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 15 Aug 2012. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Guowen Shi, MD (86-13651932966, shigw228@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of stroke in a follow-up period (time frame: one year). 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 15 Aug 2012.