Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques (INSIST-HRMRI)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753555
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:
Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Many studies mainly from Euro-American population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (LRNC) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. Yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. High resolution magnetic resonance imaging (HRMRI) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. Based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Atherosclerosis, Cerebral Drug: Atorvastatin Calcium Drug: Probucol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques: a Prospective, Random, Single-center Study Based on High Resolution Magnetic Resonance Imaging
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Routine-dose statin group
Routine-dose statin group will be gaven the treatment of atorvastatin 20mg Qd for 12 months
Drug: Atorvastatin Calcium
20mg Qd for 12 months

Experimental: high-dose statin group
high-dose statin group will be gaven the treatment of atorvastatin 40-80mg Qd till 6 months at the moment the subjects will be followed up to determine plaques status by HRMRI examination, among which the subjects presenting culprit plaque progression with the significant increasing of plaque burden including intraplaque hemorrhage will be again randomized into two groups at a ratio of 1:1 as followed: atorvastatin-probucol group will be administrated atorvastatin 40-80mg Qd plus probucol 0.5g Bid till 12 months, the other group will maintain the original scheme till 12 months.
Drug: Atorvastatin Calcium
40-80mg Qd for 6 months

Drug: Probucol
0.5g Bid for 6 months




Primary Outcome Measures :
  1. Changes in remodeling index after the statin treatment [ Time Frame: baseline, 6 months, 12 months after treatment ]
    remodeling index: crimed vessel area/normal vessel area on high-resolution MRI

  2. Changes in plaque burden after the statin treatment [ Time Frame: baseline, 6 months, 12 months after treatment ]
    plaque burden: crimed vessel wall area/crimed vessel area on high-resolution MRI

  3. Changes plaque composition in after the statin treatment [ Time Frame: baseline, 6 months, 12 months after treatment ]
    plaque composition: lipid core and fiber tissue of plaque on high-resolution MRI


Secondary Outcome Measures :
  1. level of serum bio-markers compared with baseline [ Time Frame: 6 months ]
    Serum level of LDL、hs-CRP、sLOX1 and oxLDL

  2. level of serum bio-markers compared with baseline [ Time Frame: 12 months ]
    Serum level of LDL、hs-CRP、sLOX1 and oxLDL

  3. mRS (0-2) [ Time Frame: 6 months ]
    proportion of mRS (0-2)

  4. mRS (0-2) [ Time Frame: 12 months ]
    proportion of mRS (0-2)

  5. vascular events [ Time Frame: 6 months ]
    incidence of Transient ischemic attack, stroke or other vascular events

  6. vascular events [ Time Frame: 12 months ]
    incidence of Transient ischemic attack, stroke or other vascular events

  7. abnormal test data [ Time Frame: 12 months ]
    incidence of abnormal liver function or muscle enzyme levels

  8. any adverse event [ Time Frame: 12 months ]
    incidence of adverse event

  9. death of any causes [ Time Frame: 12months ]
    proportion of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient age between 18-80 years
  2. Time of onset: within 1 week
  3. NIHSS score ≤12
  4. Acute ischemic stroke confirmed by head CT or MRI
  5. Premorbid mRS ≤1
  6. The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side <50%
  7. The culprit plaque or possible culprit plaque with plaque burden of 40% or more found by HRMRI in the proximal part of the middle cerebral artery M1 segment or basilar artery of ipsilateral lesion
  8. Signed informed consent

Exclusion Criteria:

  1. Intracranial hemorrhage found by head CT
  2. Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
  3. Severe hepatic or renal dysfunction
  4. Pregnant females
  5. Abnormal elevation of creatine phosphokinase
  6. Expected stent angioplasty
  7. Blood sugar is out of control
  8. Receiving statins within 1 month before onset
  9. Obstinate hypertension with more than 140/90 mmHg after medication
  10. Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
  11. Unsuitable for this clinical studies assessed by researcher

Information from the National Library of Medicine

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): NCT03753555


Contacts
Layout table for location contacts
Contact: Xinhong Wang, Doctor 15309885658 ext 024-28897512 450341972@qq.com
Contact: Yu Cui, Master 18842398646 ext 024-28897512 314486939@qq.com

Locations
Layout table for location information
China
General Hospital of ShenYang Military Region Recruiting
ShenYang, China
Contact: Cheng Xia, Ph.D       xiacheng1975@sina.com   
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Layout table for investigator information
Study Chair: Huisheng Chen, Doctor Neurology Department

Layout table for additonal information
Responsible Party: Hui-Sheng Chen, Department Chairman, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03753555     History of Changes
Other Study ID Numbers: k(2018)44
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Intracranial Arteriosclerosis
Atherosclerosis
Ischemia
Plaque, Atherosclerotic
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Pathological Conditions, Anatomical
Intracranial Arterial Diseases
Calcium, Dietary
Atorvastatin
Probucol
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors