Intracranial Hemorrhage Risk of Intensive Statin in Acute Ischemic Stroke With Cerebral Microbleeds

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sichuan Provincial People's Hospital
• Collaborator: Science & Technology Department of Sichuan Province
• Treatments: Atorvastatin; Calcium; Calcium, Dietary

Criteria

Inclusion Criteria:

1. Patients with a non-cardioembolic ischemic stroke within 14 days prior to entry to the study

2. Adults between the ages of 18 and 85

3. Patients with cerebral microbleeds on baseline SWI imaging

4. Patients or their legal representatives volunteer to participate and sign written informed consent

Exclusion Criteria:

1. Patients with severe acute ischemic stroke (NIHSS score ≥21)

2. Patients with coma (GCS score < 8)

3. Patients with previous moderate to severe dependence (mRS score 3-5)

4. Patients with any contraindications to CT and MRI (such as metal implants, claustrophobia, etc.)

5. Patients who are allergic to atorvastatin or excipients

6. 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

7. Patients within 6 months after hemorrhagic stroke

8. Patients with hemorrhagic tendency, such as abnormal coagulation function, Henoch-Schonlein purpura, platelet count less than 100×109/L or abnormal platelet function, etc

9. 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;

10. Patients with severe hypertension (systolic blood pressure ≥ 185 mmHg or diastolic blood pressure ≥ 110 mmHg) that has not been controlled by treatment

11. Patients with hypoglycemia (< 2.7 mmol/L) or hyperglycemia (>22.2 mmol/L)

12. Patients with previous cerebral arteritis, brain tumor, cerebral parasitic disease, cerebral arteriovenous malformation, cerebral cavernous hemangioma, cerebral aneurysm, severe craniocerebral injury, or intracranial infection

13. 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

14. Patients contraindicate to antiplatelet therapy;

15. Patients who must use other types of statins or other types of lipid-lowering drugs such as ezetimibe

16. Patients with severe mental disorders or dementia that are unable or unwilling to cooperate

17. 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])

18. Patients with myositis, myopathy, rhabdomyolysis, or 2 or more episodes of unexplained serum creatine kinase[CK] elevation ([CK]≥5.0×ULN)

19. 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.)

20. Women who are pregnant, breastfeeding or planning to become pregnant and who do not want to use contraception

21. Patients who participated in or are participating in other clinical trials during the 3 months prior to the study

22. Patients who are deemed ineligible for clinical trial participation by the investigator

23. Patients or their legal representatives do not consent to participate in this study