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

NCT05589454 | Not Yet Recruiting Phase 4

• 1 other identifier: zjl8803302022NSCSC1374
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acute Ischemic Stroke; Cerebral Microbleeds

Keywords

Acute Ischemic Stroke; Intracranial Hemorrhage Risk; Cerebral Microbleeds; Intensive Statin Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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

  From date of randomization until the end of the study, assessed up to 36 months

Secondary Outcomes (20)

• The Incidence of recurrent ischemic stroke and transient ischemic attack

  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

  From date of randomization until the date of the first occurrence of myocardial infarction, assessed up to 36 months

• The Incidence of cardiovascular death

  From date of randomization until the date of cardiovascular death, assessed up to 36 months

• The mean of serum triglycerides (TG) levels

  From date of randomization until the end of the study, assessed up to 36 months

• The mean of serum total cholesterol (TC) levels

  From date of randomization until the end of the study, assessed up to 36 months

Study Arms (2)

High-dose atorvastatin

EXPERIMENTAL

atorvastatin calcium tablets 80 mg, quaque nocte, continue to the end of the study

Drug: Atorvastatin Calcium tablets 80mg

Low-dose atorvastatin

ACTIVE COMPARATOR

atorvastatin calcium tablets 20 mg, quaque nocte, continue to the end of the study

Drug: Atorvastatin Calcium tablets 20mg

Interventions

Atorvastatin Calcium tablets 80mg DRUG

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

High-dose atorvastatin

Atorvastatin Calcium tablets 20mg DRUG

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

Low-dose atorvastatin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with severe acute ischemic stroke (NIHSS score ≥21)
• Patients with coma (GCS score \< 8)
• 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 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 with hemorrhagic tendency, such as abnormal coagulation function, Henoch-Schonlein purpura, platelet count less than 100×109/L or abnormal platelet function, etc
• 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 hypoglycemia (\< 2.7 mmol/L) or hyperglycemia (\>22.2 mmol/L)
• 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

Sponsors & Collaborators

• Sichuan Provincial People's Hospital: lead
• Science and Technology Department of Sichuan Province: collaborator

Study Sites (5)

Yunyang County People's Hospital

Chongqing, Chongqing Municipality, 404599, China

Location

Chengdu Eighth People's Hospital

Chengdu, Sichuan, 610017, China

Location

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Ya 'an People's Hospital

Ya'an, Sichuan, 625000, China

Location

Zigong Third People's Hospital

Zigong, Sichuan, 643021, China

Location

Related Publications (1)

• Zhao JL, Ai CB, Wang L, Yang SJ, Wang J, Yang W, Tang J, Zhang L, Li Y, Yan TQ, Gou S, Xie GG, Xiang Y. A multicenter, prospective, randomized controlled trial of intracranial hemorrhage risk of intensive statin therapy in patients with acute ischemic stroke combined with cerebral microbleeds (CHRISTMAS): Study protocol. Front Neurol. 2023 Feb 9;14:1097078. doi: 10.3389/fneur.2023.1097078. eCollection 2023.

  PMID: 36846138 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Jialing Zhao, MD

  Departement of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Yang Xiang, MD

  Departement of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jialing Zhao, MD

CONTACT

+8618113137196; jailynyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 21, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)