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New treatment option for Stroke, Ischemic
Official title The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques
ClinicalTrials.gov ID: NCT03753555
What this study is testing
What is Atorvastatin Calcium?
Atorvastatin Calcium is an investigational medicine, being studied as a potential treatment for stroke, ischemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
You likely can't join if
- Intracranial hemorrhage found by head CT
- Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Expected stent angioplasty
See the full eligibility criteria
- Patient age between 18-80 years
- Time of onset: within 1 week
- NIHSS score ≤12
- Acute ischemic stroke confirmed by head CT or MRI
- Premorbid mRS ≤1
- The degree of stenosis of carotid artery, vertebral artery and intracranial portion of internal carotid artery on the lesion side \<50%
- 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
- Signed informed consent
- Intracranial hemorrhage found by head CT
- Stroke attributable to cardioembolic origin (atrial fibrillation, valvular heart disease, aortic arch atherosclerosis)
- Severe hepatic or renal dysfunction
- Pregnant females
- Abnormal elevation of creatine phosphokinase
- Expected stent angioplasty
- Blood sugar is out of control
- Receiving statins within 1 month before onset
- Obstinate hypertension with more than 140/90 mmHg after medication
- Not willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures
- Unsuitable for this clinical studies assessed by researcher
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.