High and low dose atorvastatin after ischemic stroke with cerebral microbleeds
Compares atorvastatin doses and brain bleeding in stroke with microbleeds.
Key facts
- Who runs it
- Sichuan Provincial People's Hospital
- Where
- Chengdu, Chongqing, Ya'an, and Zigong, ChinaSee the 5 sites
- Trial code
- Registry title
- Intracranial Hemorrhage Risk of Intensive Statin in Acute Ischemic Stroke With Cerebral Microbleeds
- Status
- Not yet recruiting
- Phase
- Phase 4
- People taking part
- 344 people, planned
- Started
- Jan 2023
- Expected to end
- Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Atorvastatin Calcium tablets 80mg
- Atorvastatin Calcium tablets 20mg
- Record updated
- 21 October 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who had a recent stroke caused by a blocked blood vessel (not from the heart) and who have small brain bleeds called cerebral microbleeds on a scan.
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- Ischemic stroke not caused by a clot from the heart, within 14 days before joining, with cerebral microbleeds seen on a baseline SWI scan.
- Earlier treatment
- Cannot join if they had or will have clot-dissolving treatment through a vein, or need urgent or recent (within 90 days) treatment through the blood vessels. Cannot join if they must use other statins or other cholesterol-lowering drugs such as ezetimibe.
- Biomarker or test result
- Cerebral microbleeds on a baseline SWI scan.
Main reasons for not taking part
- Severe stroke (NIHSS score ≥21) or coma (GCS score < 8)
- Bleeding in the brain on CT or MRI, or a bleeding stroke within 6 months
- Tendency to bleed, such as abnormal blood clotting or platelet count less than 100×109/L
- Allergy to atorvastatin or its ingredients
- Active liver disease, muscle disease, or pregnancy, breastfeeding or planning pregnancy without contraception
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- Patients with a non-cardioembolic ischemic stroke within 14 days prior to entry to the study
- Adults between the ages of 18 and 85
- Patients with cerebral microbleeds on baseline SWI imaging
- Patients or their legal representatives volunteer to participate and sign written informed consent
Who cannot take part
- Patients with previous moderate to severe dependence (mRS score 3-5)
- Patients with any contraindications to CT and MRI (such as metal implants, claustrophobia, etc.)
- Patients with previous cerebral arteritis, brain tumor, cerebral parasitic disease, cerebral arteriovenous malformation, cerebral cavernous hemangioma, cerebral aneurysm, severe craniocerebral injury, or intracranial infection
- Patients with previous severe valvular heart disease, atrial fibrillation, acute myocardial infarction or interventional therapy in the past 6 months, heart failure (patients classified as class III-IV according to the New York Heart Association [NYHA]) or patients with indications for pacemaker placement but without pacemaker installation or other malignant arrhythmias
- Patients contraindicate to antiplatelet therapy
- Patients who must use other types of statins or other types of lipid-lowering drugs such as ezetimibe
- Patients who participated in or are participating in other clinical trials during the 3 months prior to the study
- Patients with severe acute ischemic stroke (NIHSS score ≥21)
- Patients who are allergic to atorvastatin or excipients
- Patients with intracranial hemorrhagic diseases confirmed by CT or MRI, such as cerebral hemorrhage, epidural hematoma, subdural hematoma, ventricular hemorrhage, subarachnoid hemorrhage, traumatic cerebral hemorrhage or hemorrhagic conversion of infarcts, etc
- Patients within 6 months after hemorrhagic stroke
- Patients who are ready to undergo or have undergone intravenous thrombolysis after the onset of the disease or who require urgent or recent (within 90 days) endovascular treatment
- Patients with severe hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that has not been controlled by treatment
- Patients with severe mental disorders or dementia that are unable or unwilling to cooperate
- Patients with hemorrhagic tendency, such as abnormal coagulation function, Henoch-Schonlein purpura, platelet count less than 100×109/L or abnormal platelet function, etc
- Patients with hypoglycemia (< 2.7 mmol/L) or hyperglycemia (>22.2 mmol/L)
- Patients with active liver disease or unexplained 2 or more abnormal liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] ≥ 3.0× upper limit of normal [ULN])
- Patients with myositis, myopathy, rhabdomyolysis, or 2 or more episodes of unexplained serum creatine kinase[CK] elevation ([CK]≥5.0×ULN)
- Patients with other serious systemic or organic diseases that investigators believe will not allow evaluation of efficacy or are unlikely to complete the expected course of treatment and follow-up (e.g., malignancy, life expectancy < 3 years, etc.)
- Patients with coma (GCS score < 8)
- Women who are pregnant, breastfeeding or planning to become pregnant and who do not want to use contraception
- Patients who are deemed ineligible for clinical trial participation by the investigator
- Patients or their legal representatives do not consent to participate in this study
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in China
- Chengdu Eighth People's HospitalChengdu, ChinaContact: Jialing Zhao, MDNo longer taking part
- Sichuan Academy of Medical Sciences sichuan Provincial People's HospitalChengdu, ChinaContact: Jialing Zhao, MDNo longer taking part
- Yunyang County People's HospitalChongqing, ChinaContact: Jialing Zhao, MDNo longer taking part
- Ya 'an People's HospitalYa'an, ChinaContact: Jialing Zhao, MDNo longer taking part
- Zigong Third People's HospitalZigong, ChinaContact: Jialing Zhao, MDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- High-dose atorvastatinTreatment being tested
atorvastatin calcium tablets 80 mg, quaque nocte, continue to the end of the study
Treatment: Atorvastatin Calcium tablets 80mg
- Low-dose atorvastatinExisting treatment, for comparison
atorvastatin calcium tablets 20 mg, quaque nocte, continue to the end of the study
Treatment: Atorvastatin Calcium tablets 20mg
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intracranial Hemorrhage Risk of Intensive Statin Therapy in Patients With Acute Ischemic Stroke Combined With Cerebral Microbleeds
- Plain-language title
- High and low dose atorvastatin after ischemic stroke with cerebral microbleedsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05589454, who can take part
- Publications
- Record updated
- 21 October 2022