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

NCT05589454 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2022-10-21

No results posted yet for this 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.

Conditions

  • Acute Ischemic Stroke
  • Cerebral Microbleeds

Interventions

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Science and Technology Department of Sichuan Province

    collaborator OTHER

  • Sichuan Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jialing Zhao, MD · Departement of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

  • Yang Xiang, MD · Departement of Neurology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05589454 on ClinicalTrials.gov