Strategy for Adequate Blood Pressure Lowering in the Patients With Intracranial Atherosclerosis (STABLE-ICAS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Asan Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Asan Medical Center
Collaborator:
Pfizer
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01104311
First received: April 14, 2010
Last updated: June 14, 2012
Last verified: March 2010
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Purpose
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 below 120mmHg) will not increase the ischemic lesion volumes in hemisphere compared to modest BP lowering (lowering systolic BP below 140mmHg) in the patients with symptomatic severe intracranial atherosclerosis
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Ischemia |
Procedure: Aggressive BP lowering Procedure: modest blood pressure lowering |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter Clinical Trial for Development of Guidelines of Adequate Blood Pressure Lowering in the Subacute Ischemic Stroke Patients Due to Intracranial Atherosclerosis |
Resource links provided by NLM:
Further study details as provided by Asan Medical Center:
Primary Outcome Measures:
- Ischemic lesion volume change in the whole forebrain on fluid attenuation inversion recovery (FLAIR) magnetic resonance imaging (MRI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]the difference between final ischemic lesions volume and base ischemic lesions of both hemisphere on FLAIR MRI
Secondary Outcome Measures:
- Ischemic lesion volume change in the territory of symptomatic intracranial disease on FLAIR MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]the difference between final ischemic lesions volume and base ischemic lesions in the territory of symptomatic intracranial disease on FLAIR MRI
- The number of patients with new ischemic lesion in the whole forebrain on FLAIR MRI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of cardiovascular event [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of vascular death [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of adverse event [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of adverse drug reaction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- The number of adverse drug reaction related to experimental drug [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 156 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aggressive BP lowering
Lowering of systolic blood pressure to 120mmHg during study period
|
Procedure: Aggressive BP lowering
adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
Other Name: Aggressive BP control
|
|
Active Comparator: Modest BP lowering
Lowering of systolic blood pressure below 140mmHg
|
Procedure: modest blood pressure lowering
adjust the amount and number of antihypertensive drugs
Other Name: Modest BP control
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- acute symptomatic ischemic stroke having relevant lesion on DWI MRI 7 days after and 28 days within onset.
- relevant significant stenosis(more than 50%) or occlusion of MCA(M1) or ICA on MR angiogram or CT angiogram.
- mean systolic blood pressure>=140mmHg or taking antihypertensive drug on screening.
Exclusion Criteria:
- taking more than 3 antihypertensive drugs and mean systolic blood pressure>=150mmHg on screening.
- history of recent thrombolysis but stenosis or occlusion remained after thrombolysis.
- evidence of orthostatic hypotension
- suspicious embolic cerebrovascular stenosis
- planned state of cerebrovascular surgery or angioplasty or stent 7 months within screening.
- severe stroke-NIHSS>=16
- mean systolic blood pressure>=200mmHg which is not able to control on screening.
- abnormal blood test finding (abnormal LFT, anemia, renal insufficiency)
- pregnant or breast-feeding
- severe stroke sequela or medical problem
- suspicious secondary hypertension
- disease causing edema or significant ankle edema on screening.
- severe heart failure which correspond to NYHA heart failure classification class III or IV.
- inappropriate condition determined by investigator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104311
Contacts
| Contact: Sun K Kwon, M.D. PhD | 82-2-3010-8667 | sukwon@amc.seoul.kr |
| Contact: Jong-Moo Park, M.D. PhD | 82-10-3282-1311 | jmpark@eulji.ac.kr |
Locations
| Korea, Republic of | |
| Chungnam National University Hospital | Recruiting |
| Daejeon, Chungnam, Korea, Republic of, 301-721 | |
| Contact: Hee-Jung Song, MD nrsono@cnuh.co.kr | |
| Principal Investigator: Hee-Jung Song, MD | |
| Wonju Christian Hospital | Withdrawn |
| Wonju, Gangwon, Korea, Republic of, 220-701 | |
| Wonkwang University Hospital | Recruiting |
| Iksan, Jeonbuk, Korea, Republic of, 570-711 | |
| Contact: Yosik Kim yosik@wonkwang.ac.kr | |
| Sub-Investigator: Hak Seung Lee, MD | |
| Ajou University Hospital | Terminated |
| Suwon, Kyunggi, Korea, Republic of, 443-721 | |
| Inje University Pusan Paik Hospital | Recruiting |
| Busan, Korea, Republic of, 614-735 | |
| Contact: Eung Guy Kim kgstroke@korea.com | |
| Sub-Investigator: Gyu NO Cho, MD | |
| Sub-Investigator: Won Chul Choi, MD | |
| Sub-Investigator: Jeong-Cheol Lim, MD | |
| Yeungnam University Hospital | Recruiting |
| Daegu, Korea, Republic of, 705-717 | |
| Contact: Jun Lee, MD junleeluke@gmail.com | |
| Principal Investigator: Jun Lee, MD | |
| Sub-Investigator: Jung-hyun Kim, MD | |
| Sub-Investigator: Na-young Kim, MD | |
| Sub-Investigator: Ho-sun Lee, MD | |
| Eulji University Hospital | Recruiting |
| Daejon, Korea, Republic of, 302-799 | |
| Contact: Soo Joo Lee, MD, PhD sjoolee@eulji.ac.kr | |
| Principal Investigator: Soo Joo Lee, MD, PhD | |
| Sub-Investigator: Youngchai Ko, MD, PhD | |
| Kyungpook National University Hospital | Recruiting |
| Deagu, Korea, Republic of, 700-721 | |
| Contact: Yangha Hwang yangha.hwang@gmail.com | |
| Sub-Investigator: Chung Kyu Suh, MD, PhD | |
| Chonnam National University Hospital | Recruiting |
| Gwangju, Korea, Republic of, 501-757 | |
| Contact: Ki-Hyun Cho kcho@chonnam.ac.kr | |
| Sub-Investigator: Man Seok Park, MD, PhD | |
| Sub-Investigator: Jun Tae Kim, MD, PhD | |
| Inha University Hospital | Recruiting |
| Inchon, Korea, Republic of, 400-103 | |
| Contact: Joung-Ho Rha, MD jhrha@inha.ac.kr | |
| Principal Investigator: Joung-Ho Rha, MD | |
| Dong-A University Hospital | Recruiting |
| Pusan, Korea, Republic of, 602-715 | |
| Contact: Jae-Kwan Cha nrcjk@unitel.co.kr | |
| Sub-Investigator: Dae-Hyun Kim, MD | |
| Seoul Medical Center | Recruiting |
| Seoul, Korea, Republic of, 135-740 | |
| Contact: Tai Hwan Park, MD strokezero@gmail.com | |
| Principal Investigator: Tai Hwan Park, MD | |
| Seoul National University Hospital | Terminated |
| Seoul, Korea, Republic of, 110-744 | |
| Kyung Hee University Medical Center | Recruiting |
| Seoul, Korea, Republic of, 130-702 | |
| Contact: Sung Hyuk Heo, MD shheo73@hanmail.net | |
| Principal Investigator: Sumg Hyuk Heo, MD | |
| Boramae Hospital | Recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Contact: Hyung-Min Kwon, MD, PhD hmkwon@brm.co.kr | |
| Principal Investigator: Hyung-Min Kwon, MD, PhD | |
| Sub-Investigator: Yong-Seok Lee, MD, PhD | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Contact: Sun U. Kwon sukwon@amc.seoul.kr | |
| Sub-Investigator: Sang-beom Jeon, MD | |
| Sub-Investigator: Hyun-Wook Nah, MD | |
| Sub-Investigator: youngrok Do, MD | |
| Sub-Investigator: JIN-MAN JUNG, MD | |
| Eulji Hospital | Recruiting |
| Seoul, Korea, Republic of, 139-872 | |
| Contact: Jong-Moo Park jmpark@eulji.ac.kr | |
| Sub-Investigator: ByoungKun Kim, M.D | |
| Sub-Investigator: Ohyun Kwon, M.D | |
| Sub-Investigator: JungJu Lee, M.D | |
| Sub-Investigator: Kyusik Kang, M.D | |
Sponsors and Collaborators
Asan Medical Center
Pfizer
More Information
No publications provided
| Responsible Party: | Sun U. Kwon/Principal Investigator of STABLE-ICAS, Asan Medical Center |
| ClinicalTrials.gov Identifier: | NCT01104311 History of Changes |
| Other Study ID Numbers: | STABLE-ICAS |
| Study First Received: | April 14, 2010 |
| Last Updated: | June 14, 2012 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Asan Medical Center:
|
Blood Pressure Atherosclerosis Brain Ischemia |
Additional relevant MeSH terms:
|
Atherosclerosis Brain Ischemia Ischemia Intracranial Arteriosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Pathologic Processes Intracranial Arterial Diseases Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013