Brain InfarctionPhase 4NCT00126516
Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline
A Phase 4 study testing Angiotensin II Receptor Antagonists and Angiotensin-converting Enzyme Inhibitors in people with Brain Infarction and Hypertension, run by Nara Medical University at 1 site in Japan.
Trial summary
The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Brain Infarction, Hypertension
- What is being tested?
- Angiotensin II Receptor Antagonists and Angiotensin-converting Enzyme Inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteJapan
- Study dates
- May 2004to Jun 2013
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs)
- Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging
Who cannot join
- Secondary hypertension
- Atrial fibrillation
- History or signs of cerebral disorders other than cerebrovascular disease
- Malignant tumor
- Chronic renal failure
- Severe congestive heart failure
- Hyperkalemia
- Stenosis of bilateral renal artery
Trial locations and contacts
1 site in 1 country.
Japan1 site
First Department of Internal Medicine, Nara Medical University
Kashihara, Nara, 634-8522
About this study
Official title: Effects of Angiotensin II Receptor Blockers (ARB) and Angiotensin Converting Enzyme Inhibitors (ACEI) on Progression of Silent Brain Infarction and Cognitive Decline in Japanese Patients With Essential Hypertension in the Elderly
The purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.
Read the detailed description
Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE).
Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly.
The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.
- Conditions
- Brain Infarction, Hypertension
- Being tested
- Angiotensin II Receptor Antagonists, Angiotensin-converting Enzyme Inhibitors
- Keywords
- silent brain infarction, cognitive decline, Angiotensin II Type 1 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, hypertension
- Medical subject headings
- Brain Infarction, Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II Receptor AntagonistsDrug
any dosage, frequency, and duration
Angiotensin-converting Enzyme InhibitorsDrug
any dosage, frequency, and duration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Angiotensin II Receptor Antagonists group Receives: Drug: Angiotensin II Receptor Antagonists |
| 2 | Active comparator | Angiotensin-converting Enzyme Inhibitors group Receives: Drug: Angiotensin-converting Enzyme Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatal and nonfatal stroke
Measured: two years
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging
Measured: two years
Secondary outcomes (3)
Fatal and nonfatal acute coronary syndrome
Measured: two years
Admission for heart failure
Measured: two years
All cause mortality
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 posted4 Aug 2005 (estimated)
- Study startMay 2004
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InfarctionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nara Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoshihiko Saito, Nara Medical University
- Investigators
- Yoshihiko Saito, MD, PhD, Principal investigator, First Department of Internal Medicine, Nara Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00126516
- Sponsor's protocol ID
- 03-Ken-52
- Status last verified
- Oct 2013
- First submitted
- 3 Aug 2005
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Angiotensin II Receptor Blockers (ARB) and Angiotensin Converting Enzyme Inhibitors (ACEI) on Progression of Silent Brain Infarction and Cognitive Decline in Japanese Patients With Essential Hypertension in the Elderly
- ClinicalTrials.gov ID
- NCT00126516
- Acronym / sponsor ID
- 03-Ken-52
- Conditions
- Brain Infarction, Hypertension
- Keywords
- silent brain infarction, cognitive decline, Angiotensin II Type 1 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Nara Medical UniversityUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 4 Aug 2005 (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 purpose of this study is to elucidate whether or not angiotensin II receptor blockers (ARB) are more beneficial or equal to angiotensin converting enzyme inhibitors (ACEI) on development or progression of silent brain infarction and cognitive decline in Japanese patients with essential hypertension in the elderly.
Detailed description
Hypertension plays a major role in the development of cardiovascular diseases. Treating hypertension has been associated with reduction in the risk of stroke and myocardial infarction. Angiotensin converting enzyme inhibitor (ACEI), ramipril, showed a 32 % in relative risk of reduction in the Heart Outcomes Prevention Evaluation (HOPE) trial. Angiotensin II receptor blocker (ARB), losartan, also showed a 25 % in relative risk of reduction in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE).
Elderly people, especially hypertensive patients, with silent brain infarction have an increased risk of stroke and cognitive decline. However, no reports are seen on comparison of the effects of ARBs and ACEIs on progression of silent brain infarction and cognitive decline in patients with essential hypertension in the elderly.
The researchers therefore longitudinally evaluate silent brain infarction using magnetic resonance imaging and cognitive decline by Mini-Mental State Examination twice at an interval of 2 years in patients with essential hypertension in the elderly who are received antihypertensive therapy by ARB or ACEI.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Angiotensin II Receptor AntagonistsAngiotensin II Receptor Antagonists group |
| 2 | Active comparator | Drug: Angiotensin-converting Enzyme InhibitorsAngiotensin-converting Enzyme Inhibitors group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with essential hypertension (systolic blood pressure>=140 mmHg and/or diastolic blood pressure>=90, or treated with antihypertensive drugs)
- Patients with any finding of stroke, silent brain infarction, and white matter lesion on magnetic resonance imaging
Key exclusion criteria (8 listed)
- Secondary hypertension
- Atrial fibrillation
- History or signs of cerebral disorders other than cerebrovascular disease
- Malignant tumor
- Chronic renal failure
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 |
|---|---|---|
| Angiotensin II Receptor Antagonistsany dosage, frequency, and duration | Drug | 1 |
| Angiotensin-converting Enzyme Inhibitorsany dosage, frequency, and duration | Drug | 2 |
Primary outcome
Fatal and nonfatal stroke
Time frame: two years
Progression of silent brain infarction or white matter lesion on magnetic resonance imaging
Time frame: two years
3 secondary outcomes
Fatal and nonfatal acute coronary syndrome
Time frame: two years
Admission for heart failure
Time frame: two years
All cause mortality
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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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.
Yoshihiko Saito, MD, PhD principal investigator
First Department of Internal Medicine, Nara Medical University
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 Angiotensin II Receptor Antagonists and Angiotensin-converting Enzyme Inhibitors in people with Brain Infarction and Hypertension, run by Nara Medical University at 1 site in Japan.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 30 Oct 2013. 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 Japan. 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatal and nonfatal stroke (time frame: two years). The study lists 2 primary outcomes in all. 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 30 Oct 2013.