A Phase 4 interventional study of Atorvastatin Calcium tablets 80mg and Atorvastatin Calcium tablets 20mg in Acute Ischemic Stroke and Cerebral Microbleeds, sponsored by Sichuan Provincial People's Hospital. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Sichuan Provincial People's Hospital · Phase 4, Interventional, and Prevention
This study is the first and largest secondary prevention trial about lipid-lowering therapy for acute ischemic stroke patients at high-risk of intracranial hemorrhage.
The primary hypothesis of this study is: excessive reduction in serum lipid levels by intensive statin therapy in acute ischemic stroke patients with cerebral microbleeds can increase the risk of intracranial hemorrhage.
This study will shed light on new clinical decisions regarding the long-term serum lipid management in these patients with dilemma in clinical practice.
Cerebral microbleeds are an important subtype of cerebral small vessel diseases that have been established in approximately one third of patients with ischemic stroke and are associated with the risk of recurrent ischemic stroke, symptomatic intracranial hemorrhage, and all-cause death. In patients with ischemic stroke or transient ischemic attack, the relative and absolute risks of intracranial hemorrhage increase more rapidly than the risk of ischemic stroke with the increase of cerebral microbleeds burden, but the absolute incidence of ischemic stroke is still higher than that of cerebral hemorrhage.
It has been generally accepted that statins can effectively prevent recurrent ischemic stroke by reducing serum lipid levels. However, both low serum lipid levels and high dose of statins are clear risk factors for intracerebral hemorrhage, and the reduction of major serum lipid levels may increase the risk of cerebral microbleeds. Of note, the risk of statin mediated hemorrhage appears to depend on the degree of lipid reduction rather than statin use per se. These observations raise concerns about the safety of lipid-lowering therapy, especially intensive lipid-lowering therapy, in patients with acute ischemic stroke and cerebral microbleeds who are at high risk for future intracranial hemorrhage. It is still not clear that how to carry on the proper management of serum lipid levels in this particular population to reduce the recurrence of ischemic events as well as hemorrhagic events, for there is still a lack of clinical studies to explore the risk and benefit of different doses of statins to achieve different degrees of lipid regulation.
So, if it is proved that excessive reduction in serum lipid levels by intensive statin therapy in acute ischemic stroke patients with cerebral microbleeds can increase the risk of future intracranial hemorrhage, we will inform new clinical decisions regarding the long-term lipid management in these patients with dilemma in clinical practice.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 344 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Sichuan Provincial People's Hospital is the lead sponsor of 76 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
atorvastatin calcium tablets 80 mg, quaque nocte, continue to the end of the study
Drug: Atorvastatin Calcium tablets 80mg
atorvastatin calcium tablets 20 mg, quaque nocte, continue to the end of the study
Drug: Atorvastatin Calcium tablets 20mg
Atorvastatin calcium tablets 4 pills (80 mg) will be given at a fixed time every night (24 ± 1 h between two doses) , orally, until the end of follow-up
Also known as: ALe produced by Jialin pharmaceutical company
Atorvastatin calcium tablets 1 pill (20 mg) will be given at a fixed time every night (24 ± 1 h between two doses) , orally, until the end of follow-up
Also known as: ALe produced by Jialin pharmaceutical company
The incidence of hemorrhagic strokes
Time frame: From date of randomization until the date of the first occurrence of hemorrhagic stroke, assessed up to 36 months
Changes in degree of cerebral microbleeds
The degree is divided into: mild (1-2), moderate (3-10), severe (more than 10), calculate and compare the proportions of different degrees at baseline and the end of the study
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The Incidence of recurrent ischemic stroke and transient ischemic attack
Time frame: From date of randomization until the date of the first recurrent of ischemic stroke or the first occurrence of transient ischemic attack, assessed up to 36 months
The Incidence of myocardial infarction
Time frame: From date of randomization until the date of the first occurrence of myocardial infarction, assessed up to 36 months
The Incidence of cardiovascular death
Time frame: From date of randomization until the date of cardiovascular death, assessed up to 36 months
The mean of serum triglycerides (TG) levels
Calculate the mean of serum TG levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The mean of serum total cholesterol (TC) levels
Calculate the mean of serum TC levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The mean of serum low-density lipoprotein cholesterol (LDL-C) levels
Calculate the mean of serum LDL-C levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The mean of serum high-density lipoprotein cholesterol (HDL-C) levels
Calculate the mean of serum HDL-C levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The variability of serum triglycerides (TG) levels
Calculate the variability of serum TG levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The variability of serum total cholesterol (TC) levels
Calculate the variability of serum TC levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The variability of serum low-density lipoprotein cholesterol (LDL-C) levels
Calculate the variability of serum LDL-C levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The variability of serum high-density lipoprotein cholesterol (HDL-C) levels
Calculate the variability of serum HDL-C levels for 3 years with at least 3 measurements
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The proportions of different degrees of CMBs at the end of the study
Calculate the proportions of different degrees of CMBs (mild, moderate and severe) at the end of the study
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the mean of serum triglycerides (TG) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the mean of serum total cholesterol (TC) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the mean of serum low-density lipoprotein cholesterol (LDL-C) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the mean of serum high-density lipoprotein cholesterol (HDL-C) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the variability of serum triglycerides (TG) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the variability of serum total cholesterol (TC) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the variability of serum low-density lipoprotein cholesterol (LDL-C) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
The correlation between the variability of serum high-density lipoprotein cholesterol (HDL-C) levels and the proportions of different degrees of CMBs
Time frame: From date of randomization until the end of the study, assessed up to 36 months
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Sichuan Provincial People's Hospital