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Starting soon Phase 4

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

NCT05589454 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2023-01
Last updated
2022-10-21

Condition(s) studied

Acute Ischemic StrokeCerebral Microbleeds

Investigational drug(s) / intervention(s)

Atorvastatin Calcium tablets 80mg →Atorvastatin Calcium tablets 20mg →

Atorvastatin Calcium tablets 80mg: 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

Atorvastatin Calcium tablets 20mg: 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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • The incidence of hemorrhagic strokes — 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 — From date of randomization until the end of the study, assessed up to 36 months
    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

Trial sites (5)

FacilityCityRegionStatus
Yunyang County People's Hospital Chongqing Chongqing Municipality
Chengdu Eighth People's Hospital Chengdu Sichuan
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu Sichuan
Ya 'an People's Hospital Ya'an Sichuan
Zigong Third People's Hospital Zigong Sichuan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05589454 on ClinicalTrials.gov ↗ ← All trials in China