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NOT YET RECRUITING
NCT05589454
PHASE4

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

Sponsor: Sichuan Provincial People's Hospital

View on ClinicalTrials.gov

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.

Official title: Intracranial Hemorrhage Risk of Intensive Statin Therapy in Patients With Acute Ischemic Stroke Combined With Cerebral Microbleeds

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

344

Start Date

2023-01

Completion Date

2027-06

Last Updated

2022-10-21

Healthy Volunteers

No

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

Locations (5)

Yunyang County People's Hospital

Chongqing, Chongqing Municipality, China

Chengdu Eighth People's Hospital

Chengdu, Sichuan, China

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

Chengdu, Sichuan, China

Ya 'an People's Hospital

Ya'an, Sichuan, China

Zigong Third People's Hospital

Zigong, Sichuan, China