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The enrollment was not done actively even though enrollment period was extended due to poor enrollment.
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To develop adequate blood pressure (BP) lowering strategy after subacute ischemic stroke patients with symptomatic severe intracranial atherosclerosis.
Primary hypothesis of this study is that aggressive BP control (lowering systolic BP between 110mmHg and 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP between 130mmHg and 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis.
The benefits of BP lowering in the prevention of primary and secondary prevention of stroke is established well, although absolute target BP level is uncertain. Current guidelines defined the normal BP as <120/80mmHg and recommend individualized target BP level.
Large well performed stroke prevention trials consistently showed that reduction of 10/5mmHg in patients with systolic BP below 140mmHg had clear benefits in the prevention of cardiovascular events. However, we have a dilemma about BP control in the patients with severe intracranial atherosclerosis.
Aggressive BP control will be more effective in the prevention of overall cardiovascular events than modest BP control, but aggressive BP control will reduce cerebral perfusion in the territory of severe intracranial disease and may increase the risk of ischemic damage.
The study will try to reveal aggressive BP control in the patients with symptomatic severe intracranial atherosclerosis is not increase ischemic lesion volume in hemisphere to compare modest BP control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aggressive BP lowering | Experimental | Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period |
|
| Modest BP lowering | Active Comparator | Lowering of systolic blood pressure between 130mmHg and 140mmHg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aggressive BP lowering | Procedure | adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) | The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI | Screening to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population | the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI | 24 weeks |
| The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | Chungcheongnam-do | 301-721 | South Korea | ||
| Myongji Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29847486 | Derived | Park JM, Kim BJ, Kwon SU, Hwang YH, Heo SH, Rha JH, Lee J, Park MS, Kim JT, Song HJ, Park JH, Yu S, Lee SJ, Park TH, Cha JK, Kwon HM, Kim EG, Lee SH, Lee JS, Lee J. Intensive blood pressure control may not be safe in subacute ischemic stroke by intracranial atherosclerosis: a result of randomized trial. J Hypertens. 2018 Sep;36(9):1936-1941. doi: 10.1097/HJH.0000000000001784. |
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There is no plan to share data yet. It will be discussed with investigators who have been participating in this study.
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There were not any significant events and approaches for the overall study following participant enrollment.
The recruitment period of this study was from 07/Apr/2010 to 2/Apr/2014 and there had been recruited at medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aggressive BP Lowering | Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level |
| FG001 | Modest BP Lowering |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| modest blood pressure lowering | Procedure | adjust the amount and number of antihypertensive drugs |
|
|
| 24 weeks |
| Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population. | 24 weeks |
| Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population. | 24 Week |
| Number of Participants With Vascular Death From Screening to Week 24 in ITT Population. | 24 Weeks |
| Number of Participants With Adverse Events | Number of Participants with Adverse Events | 24 Weeks |
| Goyang-si |
| Gyeonggi-do |
| 412-270 |
| South Korea |
| Wonkwang University Hospital | Iksan | Jeollabuk-do | 570-711 | South Korea |
| Inje University Pusan Paik Hospital | Busan | 614-735 | South Korea |
| Yeungnam University Hospital | Daegu | 705-717 | South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Kyungpook National University Hospital | Deagu | 700-721 | South Korea |
| Chonnam National University Hospital | Gwangju | 501-757 | South Korea |
| Inha University Hospital | Inchon | 400-103 | South Korea |
| Dong-A University Hospital | Pusan | 602-715 | South Korea |
| Kyung Hee University Medical Center | Seoul | 130-702 | South Korea |
| Seoul Medical Center | Seoul | 135-740 | South Korea |
| Korea University Anam Hospital | Seoul | 136-705 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Eulji Hospital | Seoul | 139-872 | South Korea |
| Boramae Hospital | Seoul | 156-707 | South Korea |
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs |
| COMPLETED |
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| NOT COMPLETED |
|
|
The overall number of baseline participatns are analyzed by ITTpopulation ITT Population (Aggressive BP Lowring: 66, Modest BP Lowering: 63)
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| ID | Title | Description |
|---|---|---|
| BG000 | Aggressive BP Lowering | Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level |
| BG001 | Modest BP Lowering | Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI) | The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI | The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52) | Posted | Mean | Standard Deviation | cc | Screening to 24 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population | the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI | The number of participants are analyzed by FAS population. | Posted | Mean | Standard Deviation | cc | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI | The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63) | Posted | Number | participants | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population. | The number of participants are analyzed by ITT Population. | Posted | Number | participants | 24 weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population. | The number of participants are analyzed by ITT population. | Posted | Number | events | 24 Week |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Vascular Death From Screening to Week 24 in ITT Population. | The number of participants are analyzed by ITT population. | Posted | Number | participants | 24 Weeks |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events | Number of Participants with Adverse Events | The number of participants are analyzed by Safety population. | Posted | Number | participants | 24 Weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aggressive BP Lowering | Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65) | 10 | 65 | 51 | 65 | ||
| EG001 | Modest BP Lowering | Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65) | 8 | 65 | 47 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FRACTURE | Musculoskeletal and connective tissue disorders |
| |||
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders |
| |||
| INFECTION BACTERIAL | Immune system disorders |
| |||
| OVARIAN CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| COLON CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| GENITAL NEOPLASM MALIGNANT MALE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| PYELONEPHRITIS | Renal and urinary disorders |
| |||
| GASTRIC ULCER HAEMORRHAGIC | Gastrointestinal disorders |
| |||
| ASTHENIA | General disorders |
| |||
| DELIRIUM | Psychiatric disorders |
| |||
| HEADACHE | Nervous system disorders |
| |||
| NEUROPATHY | Nervous system disorders |
| |||
| DIZZINESS | Nervous system disorders |
| |||
| STUPOR | Nervous system disorders |
| |||
| CEREBRAL INFARCTION | Vascular disorders |
| |||
| TRANSIENT ISCHAEMIC ATTACK | Vascular disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEPATIC ENZYMES INCREASED | Hepatobiliary disorders |
| |||
| GALLBLADDER DISORDER | Hepatobiliary disorders |
| |||
| BILIRUBINAEMIA | Hepatobiliary disorders |
| |||
| SKELETAL PAIN | Musculoskeletal and connective tissue disorders |
| |||
| FRACTURE | Musculoskeletal and connective tissue disorders |
| |||
| ARTHRITIS | Musculoskeletal and connective tissue disorders |
| |||
| ARTHRALGIA | Musculoskeletal and connective tissue disorders |
| |||
| MUSCLE WEAKNESS | Musculoskeletal and connective tissue disorders |
| |||
| MYALGIA | Musculoskeletal and connective tissue disorders |
| |||
| ROTARY CUFF SYNDROME | Musculoskeletal and connective tissue disorders |
| |||
| HYPERTRIGLYCERIDAEMIA | Metabolism and nutrition disorders |
| |||
| HYPERLIPAEMIA | Metabolism and nutrition disorders |
| |||
| DIABETES MELLITUS | Metabolism and nutrition disorders |
| |||
| HYPOGLYCAEMIA | Metabolism and nutrition disorders |
| |||
| ABSCESS | Immune system disorders |
| |||
| HERPES ZOSTER | Immune system disorders |
| |||
| INFECTION BACTERIAL | Immune system disorders |
| |||
| LEUCOPENIA | Blood and lymphatic system disorders |
| |||
| PROSTATIC HYPERPLASIA | Reproductive system and breast disorders |
| |||
| BLEPHARITIS | Eye disorders |
| |||
| OVARIAN CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| COLON CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| GENITAL NEOPLASM MALIGNANT MALE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
| |||
| ANGINA PECTORIS | Cardiac disorders |
| |||
| HYPERTENSION AGGRAVATED | Vascular disorders |
| |||
| HYPOTENSION POSTURAL | Vascular disorders |
| |||
| RENAL FAILURE CHRONIC | Renal and urinary disorders |
| |||
| BLADDER CALCULUS | Renal and urinary disorders |
| |||
| MICTURITION DISORDER | Renal and urinary disorders |
| |||
| MICTURITION FREQUENCY | Renal and urinary disorders |
| |||
| PYELONEPHRITIS | Renal and urinary disorders |
| |||
| NOCTURIA | Renal and urinary disorders |
| |||
| FACE OEDEMA | Renal and urinary disorders |
| |||
| AZOTAEMIA | Reproductive system and breast disorders |
| |||
| HAEMATURIA | Renal and urinary disorders |
| |||
| VOMITING | Gastrointestinal disorders |
| |||
| CONSTIPATION | Gastrointestinal disorders |
| |||
| ABDOMINAL PAIN | Gastrointestinal disorders |
| |||
| DIARRHOEA | Gastrointestinal disorders |
| |||
| DYSPEPSIA | Gastrointestinal disorders |
| |||
| NAUSEA | Gastrointestinal disorders |
| |||
| GASTRIC ULCER | Gastrointestinal disorders |
| |||
| GASTRITIS | Gastrointestinal disorders |
| |||
| GASTROENTERITIS | Gastrointestinal disorders |
| |||
| GASTRIC ULCER HAEMORRHAGIC | Gastrointestinal disorders |
| |||
| PERIODONTAL DISORDERS | Gastrointestinal disorders |
| |||
| PERIODONTAL DESTRUCTION | Gastrointestinal disorders |
| |||
| MELAENA | Gastrointestinal disorders |
| |||
| C-REACTIVE PROTEIN INCREASED | General disorders |
| |||
| CHEST PAIN | General disorders |
| |||
| OEDEMA PERIPHERAL | General disorders |
| |||
| ASTHENIA | General disorders |
| |||
| ABDOMEN ENLARGED | General disorders |
| |||
| SYNCOPE | General disorders |
| |||
| ALLERGIC REACTION | General disorders |
| |||
| FEVER | General disorders |
| |||
| OEDEMA GENERALISED | General disorders |
| |||
| FATIGUE | General disorders |
| |||
| AMNESIA | General disorders |
| |||
| INSOMNIA | General disorders |
| |||
| ANXIETY | General disorders |
| |||
| DELIRIUM | General disorders |
| |||
| ANOREXIA | General disorders |
| |||
| DEPRESSION | General disorders |
| |||
| PARAESTHESIA | Nervous system disorders |
| |||
| HYPOAESTHESIA | Nervous system disorders |
| |||
| HEADACHE | Nervous system disorders |
| |||
| PARALYSIS | Nervous system disorders |
| |||
| NEUROPATHY PERIPHERAL | Nervous system disorders |
| |||
| DYSPHONIA | Nervous system disorders |
| |||
| GAIT ABNORMAL | Nervous system disorders |
| |||
| VISUAL FIELD DEFECT | Nervous system disorders |
| |||
| NEUROPATHY | Nervous system disorders |
| |||
| APHASIA | Nervous system disorders |
| |||
| PTOSIS | Nervous system disorders |
| |||
| DIZZINESS | Nervous system disorders |
| |||
| SPEECH DISORDER | Nervous system disorders |
| |||
| COGNITIVE DISORDERS | Nervous system disorders |
| |||
| DEMENTIA | Nervous system disorders |
| |||
| APRAXIA | Nervous system disorders |
| |||
| STUPOR | Nervous system disorders |
| |||
| TINNITUS | Ear and labyrinth disorders |
| |||
| PRURITUS | Skin and subcutaneous tissue disorders |
| |||
| URTICARIA | Skin and subcutaneous tissue disorders |
| |||
| RASH | Skin and subcutaneous tissue disorders |
| |||
| ECZEMA | Skin and subcutaneous tissue disorders |
| |||
| OTITIS EXTERNA | Skin and subcutaneous tissue disorders |
| |||
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders |
| |||
| DERMATITIS FUNGAL | Skin and subcutaneous tissue disorders |
| |||
| SKIN EXFOLIATION | Skin and subcutaneous tissue disorders |
| |||
| CEREBRAL INFARCTION | Vascular disorders |
| |||
| RENAL ARTERY OCCLUSION | Vascular disorders |
| |||
| TRANSIENT ISCHAEMIC ATTACK | Vascular disorders |
| |||
| GINGIVAL BLEEDING | Blood and lymphatic system disorders |
| |||
| PURPURA | Blood and lymphatic system disorders |
| |||
| COUGHING | Respiratory, thoracic and mediastinal disorders |
| |||
| RHINITIS | Respiratory, thoracic and mediastinal disorders |
| |||
| UPPER RESPIRATORY TRACT INFECTIO | Respiratory, thoracic and mediastinal disorders |
| |||
| PHARYNGITIS | Respiratory, thoracic and mediastinal disorders |
| |||
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders |
| |||
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders |
| |||
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun U. Kwon, MD, PhD, Prof | Asan Medical Center, University of Ulsan | 82-2-3010-3960 | sukwon@amc.seoul.kr |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| Male |
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| Change from Screening to Week 24 |
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