Angiotensin II Receptor Blockers (ARB) and ACE Inhibitors (ACEI) on Silent Brain Infarction and Cognitive Decline
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ClinicalTrials.gov Identifier: NCT00126516 |
Recruitment Status :
Completed
First Posted : August 4, 2005
Last Update Posted : October 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Infarction Hypertension | Drug: Angiotensin II Receptor Antagonists Drug: Angiotensin-converting Enzyme Inhibitors | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 395 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Angiotensin II Receptor Antagonists group
|
Drug: Angiotensin II Receptor Antagonists
any dosage, frequency, and duration |
Active Comparator: 2
Angiotensin-converting Enzyme Inhibitors group
|
Drug: Angiotensin-converting Enzyme Inhibitors
any dosage, frequency, and duration |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126516
Japan | |
First Department of Internal Medicine, Nara Medical University | |
Kashihara, Nara, Japan, 634-8522 |
Principal Investigator: | Yoshihiko Saito, MD, PhD | First Department of Internal Medicine, Nara Medical University |
Responsible Party: | Yoshihiko Saito, Professor, Nara Medical University |
ClinicalTrials.gov Identifier: | NCT00126516 |
Other Study ID Numbers: |
03-Ken-52 |
First Posted: | August 4, 2005 Key Record Dates |
Last Update Posted: | October 30, 2013 |
Last Verified: | October 2013 |
silent brain infarction cognitive decline Angiotensin II Type 1 Receptor Blockers Angiotensin-Converting Enzyme Inhibitors hypertension |
Brain Infarction Hypertension Infarction Cognitive Dysfunction Vascular Diseases Cardiovascular Diseases Ischemia Pathologic Processes Necrosis Cognition Disorders Neurocognitive Disorders Mental Disorders Brain Ischemia Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Stroke Angiotensin II Giapreza Enzyme Inhibitors Angiotensinogen Angiotensin-Converting Enzyme Inhibitors Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Serine Proteinase Inhibitors Protease Inhibitors |