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Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis (STABLE-ICAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01104311
Recruitment Status : Terminated (The enrollment was not done actively even though enrollment period was extended due to poor enrollment.)
First Posted : April 15, 2010
Results First Posted : March 7, 2017
Last Update Posted : March 7, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Sun U. Kwon, Asan Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Brain Ischemia
Interventions Procedure: Aggressive BP lowering
Procedure: modest blood pressure lowering
Enrollment 132
Recruitment Details The recruitment period of this study was from 07/Apr/2010 to 2/Apr/2014 and there had been recruited at medical clinic.
Pre-assignment Details There were not any significant events and approaches for the overall study following participant enrollment.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs

Period Title: Overall Study
Started 66 66
Completed 56 54
Not Completed 10 12
Reason Not Completed
Withdrawal by Subject             6             6
Protocol Violation             0             1
Physician Decision             2             2
low compliance             1             1
Adverse Event             1             2
Arm/Group Title Aggressive BP Lowering Modest BP Lowering Total
Hide Arm/Group Description 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 Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs Total of all reporting groups
Overall Number of Baseline Participants 66 63 129
Hide Baseline Analysis Population Description
The overall number of baseline participatns are analyzed by ITTpopulation ITT Population (Aggressive BP Lowring: 66, Modest BP Lowering: 63)
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 63 participants 129 participants
64.8  (8.5) 63.5  (11.2) 64.2  (9.85)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 63 participants 129 participants
Female
25
  37.9%
27
  42.9%
52
  40.3%
Male
41
  62.1%
36
  57.1%
77
  59.7%
1.Primary Outcome
Title Ischemic Lesion Volume Change in the Whole Forebrain on Fluid Attenuation Inversion Recovery (FLAIR) Magnetic Resonance Imaging (MRI)
Hide Description The difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Time Frame Screening to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Number of Participants Analyzed by FAS(Full analysis)Population. FAS Population (Aggressive BP Lowering: 59, Modest BP Lowering: 52)
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:
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
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
Overall Number of Participants Analyzed 59 52
Mean (Standard Deviation)
Unit of Measure: cc
Screening 11.2  (24.1) 10.4  (19.4)
Week 24 16.1  (39.3) 12.6  (20.0)
Change from Screening to Week 24 4.9  (18.3) 2.2  (8.2)
2.Secondary Outcome
Title Change of the Ischemic Lesion Volume in Cerebral Hemisphere on FLAIR From Screening to Week 24 in FAS Population
Hide Description the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants are analyzed by FAS population.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs

Overall Number of Participants Analyzed 59 52
Mean (Standard Deviation)
Unit of Measure: cc
Screening 10.2  (22.6) 9.9  (19.4)
Week 24 15.0  (38.6) 12.0  (20.0)
Change from Screening to Week 24 4.9  (18.3) 2.1  (8.2)
3.Secondary Outcome
Title The Number of Patients With New Ischemic Lesion in the Whole Forebrain on FLAIR MRI
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Number of Participants are analyzed by ITT (Intent to treat) Population. ITT Population (Aggressive BP Lowering: 66, Modest BP Lowering: 63)
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:
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
Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
Overall Number of Participants Analyzed 66 63
Measure Type: Number
Unit of Measure: participants
Yes 10 5
No 49 47
Missing data 7 11
4.Secondary Outcome
Title Number of Participants With Cardiovascular Events From Screening to Week 24 in ITT Population.
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants are analyzed by ITT Population.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs

Overall Number of Participants Analyzed 66 63
Measure Type: Number
Unit of Measure: participants
14 14
5.Secondary Outcome
Title Total Number of Cardiovascular Events Form Screening to Week 24 in ITT Population.
Hide Description [Not Specified]
Time Frame 24 Week
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants are analyzed by ITT population.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs

Overall Number of Participants Analyzed 66 63
Measure Type: Number
Unit of Measure: events
17 15
6.Secondary Outcome
Title Number of Participants With Vascular Death From Screening to Week 24 in ITT Population.
Hide Description [Not Specified]
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants are analyzed by ITT population.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:

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

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs

Overall Number of Participants Analyzed 66 63
Measure Type: Number
Unit of Measure: participants
0 0
7.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Number of Participants with Adverse Events
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants are analyzed by Safety population.
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description:

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)

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)

Overall Number of Participants Analyzed 65 65
Measure Type: Number
Unit of Measure: participants
With at least on AE 51 47
With at leat one SAE 10 8
Withdrawn due to AE 1 4
With AE due to the treatment 5 3
Who died 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Aggressive BP Lowering Modest BP Lowering
Hide Arm/Group Description

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)

Lowering of systolic blood pressure between 130mmHg and 140mmHg

modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)

All-Cause Mortality
Aggressive BP Lowering Modest BP Lowering
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Aggressive BP Lowering Modest BP Lowering
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/65 (15.38%)      8/65 (12.31%)    
Gastrointestinal disorders     
GASTRIC ULCER HAEMORRHAGIC  0/65 (0.00%)  0 1/65 (1.54%)  1
General disorders     
ASTHENIA  1/65 (1.54%)  1 1/65 (1.54%)  1
Immune system disorders     
INFECTION BACTERIAL  1/65 (1.54%)  1 0/65 (0.00%)  0
Musculoskeletal and connective tissue disorders     
FRACTURE  1/65 (1.54%)  1 0/65 (0.00%)  0
MUSCLE WEAKNESS  0/65 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
OVARIAN CARCINOMA  0/65 (0.00%)  0 1/65 (1.54%)  1
COLON CARCINOMA  1/65 (1.54%)  1 0/65 (0.00%)  0
GENITAL NEOPLASM MALIGNANT MALE  0/65 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
HEADACHE  1/65 (1.54%)  1 0/65 (0.00%)  0
NEUROPATHY  1/65 (1.54%)  1 0/65 (0.00%)  0
DIZZINESS  2/65 (3.08%)  2 1/65 (1.54%) 
STUPOR  0/65 (0.00%)  0 1/65 (1.54%)  1
Psychiatric disorders     
DELIRIUM  1/65 (1.54%)  1 0/65 (0.00%)  0
Renal and urinary disorders     
PYELONEPHRITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
Vascular disorders     
CEREBRAL INFARCTION  0/65 (0.00%)  0 1/65 (1.54%)  1
TRANSIENT ISCHAEMIC ATTACK  1/65 (1.54%)  1 0/65 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Aggressive BP Lowering Modest BP Lowering
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/65 (78.46%)      47/65 (72.31%)    
Blood and lymphatic system disorders     
LEUCOPENIA  0/65 (0.00%)  0 1/65 (1.54%)  1
GINGIVAL BLEEDING  1/65 (1.54%)  1 0/65 (0.00%)  0
PURPURA  2/65 (3.08%)  3 0/65 (0.00%)  0
Cardiac disorders     
ANGINA PECTORIS  1/65 (1.54%)  1 0/65 (0.00%)  0
Ear and labyrinth disorders     
TINNITUS  1/65 (1.54%)  1 0/65 (0.00%)  0
Eye disorders     
BLEPHARITIS  1/65 (1.54%)  1 0/65 (0.00%)  0
Gastrointestinal disorders     
VOMITING  2/65 (3.08%)  3 0/65 (0.00%)  0
CONSTIPATION  4/65 (6.15%)  4 3/65 (4.62%)  3
ABDOMINAL PAIN  1/65 (1.54%)  1 0/65 (0.00%)  0
DIARRHOEA  3/65 (4.62%)  3 2/65 (3.08%)  3
DYSPEPSIA  2/65 (3.08%)  2 2/65 (3.08%)  2
NAUSEA  1/65 (1.54%)  1 2/65 (3.08%)  3
GASTRIC ULCER  1/65 (1.54%)  1 0/65 (0.00%)  0
GASTRITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
GASTROENTERITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
GASTRIC ULCER HAEMORRHAGIC  0/65 (0.00%)  0 1/65 (1.54%)  1
PERIODONTAL DISORDERS  0/65 (0.00%)  0 1/65 (1.54%)  1
PERIODONTAL DESTRUCTION  2/65 (3.08%)  2 0/65 (0.00%)  0
MELAENA  1/65 (1.54%)  1 1/65 (1.54%)  1
General disorders     
C-REACTIVE PROTEIN INCREASED  1/65 (1.54%)  1 1/65 (1.54%)  1
CHEST PAIN  3/65 (4.62%)  3 1/65 (1.54%)  1
OEDEMA PERIPHERAL  3/65 (4.62%)  3 4/65 (6.15%)  4
ASTHENIA  1/65 (1.54%)  1 2/65 (3.08%)  2
ABDOMEN ENLARGED  1/65 (1.54%)  1 0/65 (0.00%)  0
SYNCOPE  0/65 (0.00%)  0 1/65 (1.54%)  1
ALLERGIC REACTION  1/65 (1.54%)  1 0/65 (0.00%)  0
FEVER  2/65 (3.08%)  2 1/65 (1.54%)  1
OEDEMA GENERALISED  0/65 (0.00%)  0 1/65 (1.54%)  1
FATIGUE  1/65 (1.54%)  1 1/65 (1.54%)  1
AMNESIA  0/65 (0.00%)  0 1/65 (1.54%)  1
INSOMNIA  2/65 (3.08%)  2 3/65 (4.62%)  3
ANXIETY  1/65 (1.54%)  1 1/65 (1.54%)  1
DELIRIUM  2/65 (3.08%)  2 0/65 (0.00%)  0
ANOREXIA  2/65 (3.08%)  2 1/65 (1.54%)  1
DEPRESSION  4/65 (6.15%)  4 5/65 (7.69%)  5
Hepatobiliary disorders     
HEPATIC ENZYMES INCREASED  2/65 (3.08%)  2 2/65 (3.08%)  2
GALLBLADDER DISORDER  0/65 (0.00%)  0 1/65 (1.54%)  1
BILIRUBINAEMIA  1/65 (1.54%)  1 0/65 (0.00%)  0
Immune system disorders     
ABSCESS  0/65 (0.00%)  0 1/65 (1.54%)  1
HERPES ZOSTER  1/65 (1.54%)  1 0/65 (0.00%)  0
INFECTION BACTERIAL  1/65 (1.54%)  1 0/65 (0.00%)  0
Metabolism and nutrition disorders     
HYPERTRIGLYCERIDAEMIA  1/65 (1.54%)  1 0/65 (0.00%)  0
HYPERLIPAEMIA  1/65 (1.54%)  1 1/65 (1.54%)  1
DIABETES MELLITUS  2/65 (3.08%)  2 1/65 (1.54%)  1
HYPOGLYCAEMIA  1/65 (1.54%)  2 0/65 (0.00%)  0
Musculoskeletal and connective tissue disorders     
SKELETAL PAIN  0/65 (0.00%)  0 1/65 (1.54%)  1
FRACTURE  1/65 (1.54%)  1 1/65 (1.54%)  1
ARTHRITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
ARTHRALGIA  4/65 (6.15%)  4 1/65 (1.54%)  1
MUSCLE WEAKNESS  1/65 (1.54%)  3 2/65 (3.08%)  3
MYALGIA  1/65 (1.54%)  1 0/65 (0.00%)  0
ROTARY CUFF SYNDROME  0/65 (0.00%)  0 1/65 (1.54%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
OVARIAN CARCINOMA  0/65 (0.00%)  0 1/65 (1.54%)  1
COLON CARCINOMA  1/65 (1.54%)  1 0/65 (0.00%)  0
GENITAL NEOPLASM MALIGNANT MALE  0/65 (0.00%)  0 1/65 (1.54%)  1
Nervous system disorders     
PARAESTHESIA  3/65 (4.62%)  3 2/65 (3.08%)  2
HYPOAESTHESIA  1/65 (1.54%)  1 2/65 (3.08%)  2
HEADACHE  8/65 (12.31%)  10 12/65 (18.46%)  13
PARALYSIS  1/65 (1.54%)  1 0/65 (0.00%)  0
NEUROPATHY PERIPHERAL  0/65 (0.00%)  0 1/65 (1.54%)  1
DYSPHONIA  0/65 (0.00%)  0 1/65 (1.54%)  1
GAIT ABNORMAL  1/65 (1.54%)  1 0/65 (0.00%)  0
VISUAL FIELD DEFECT  1/65 (1.54%)  1 0/65 (0.00%)  0
NEUROPATHY  1/65 (1.54%)  1 0/65 (0.00%)  0
APHASIA  1/65 (1.54%)  1 0/65 (0.00%)  0
PTOSIS  1/65 (1.54%)  1 0/65 (0.00%)  0
DIZZINESS  9/65 (13.85%)  9 11/65 (16.92%)  11
SPEECH DISORDER  1/65 (1.54%)  1 0/65 (0.00%)  0
COGNITIVE DISORDERS  1/65 (1.54%)  1 1/65 (1.54%)  1
DEMENTIA  0/65 (0.00%)  0 3/65 (4.62%)  3
APRAXIA  1/65 (1.54%)  1 0/65 (0.00%)  0
STUPOR  1/65 (1.54%)  1 2/65 (3.08%)  2
Renal and urinary disorders     
RENAL FAILURE CHRONIC  1/65 (1.54%)  1 0/65 (0.00%)  0
BLADDER CALCULUS  1/65 (1.54%)  1 0/65 (0.00%)  0
MICTURITION DISORDER  1/65 (1.54%)  1 0/65 (0.00%)  0
MICTURITION FREQUENCY  0/65 (0.00%)  0 1/65 (1.54%)  1
PYELONEPHRITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
NOCTURIA  1/65 (1.54%)  1 0/65 (0.00%)  0
FACE OEDEMA  1/65 (1.54%)  1 1/65 (1.54%)  1
HAEMATURIA  0/65 (0.00%)  0 1/65 (1.54%)  1
Reproductive system and breast disorders     
PROSTATIC HYPERPLASIA  0/65 (0.00%)  0 1/65 (1.54%)  1
AZOTAEMIA  1/65 (1.54%)  1 0/65 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COUGHING  3/65 (4.62%)  3 2/65 (3.08%)  3
RHINITIS  0/65 (0.00%)  0 1/65 (1.54%)  1
UPPER RESPIRATORY TRACT INFECTIO  2/65 (3.08%)  2 0/65 (0.00%)  0
PHARYNGITIS  1/65 (1.54%)  1 4/65 (6.15%)  4
EPISTAXIS  1/65 (1.54%)  1 1/65 (1.54%)  1
PNEUMONIA  0/65 (0.00%)  0 1/65 (1.54%)  1
DYSPNOEA  1/65 (1.54%)  1 0/65 (0.00%)  0
Skin and subcutaneous tissue disorders     
PRURITUS  1/65 (1.54%)  1 0/65 (0.00%)  0
URTICARIA  1/65 (1.54%)  1 0/65 (0.00%)  0
RASH  0/65 (0.00%)  0 1/65 (1.54%)  1
ECZEMA  1/65 (1.54%)  1 0/65 (0.00%)  0
OTITIS EXTERNA  0/65 (0.00%)  0 1/65 (1.54%)  1
DERMATITIS CONTACT  0/65 (0.00%)  0 1/65 (1.54%)  1
DERMATITIS FUNGAL  0/65 (0.00%)  0 1/65 (1.54%)  3
SKIN EXFOLIATION  1/65 (1.54%)  1 0/65 (0.00%)  0
Vascular disorders     
HYPERTENSION AGGRAVATED  0/65 (0.00%)  0 1/65 (1.54%)  1
HYPOTENSION POSTURAL  1/65 (1.54%)  1 0/65 (0.00%)  0
CEREBRAL INFARCTION  1/65 (1.54%)  1 1/65 (1.54%)  1
RENAL ARTERY OCCLUSION  1/65 (1.54%)  1 0/65 (0.00%)  0
TRANSIENT ISCHAEMIC ATTACK  1/65 (1.54%)  1 0/65 (0.00%)  0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sun U. Kwon, MD, PhD, Prof
Organization: Asan Medical Center, University of Ulsan
Phone: 82-2-3010-3960
EMail: sukwon@amc.seoul.kr
Layout table for additonal information
Responsible Party: Sun U. Kwon, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01104311     History of Changes
Other Study ID Numbers: STABLE-ICAS
First Submitted: April 14, 2010
First Posted: April 15, 2010
Results First Submitted: February 11, 2016
Results First Posted: March 7, 2017
Last Update Posted: March 7, 2017