Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.

This study aims to evaluate whether an upfront combination lipid-lowering therapy (statins combined with hybutimibe) can further improve the 8-week LDL-C target achievement rate (<1.8 mmol/L and ≥50% reduction from baseline) compared with a sequential lipid-lowering therapy in patients with acute ischemic stroke or transient ischemic attack (TIA)

Study Overview

• Status: Not yet recruiting
• Conditions: TIA (Transient Ischemic Attack); Ischemia Stroke
• Intervention / Treatment: Drug: Atorvastatin; Drug: Hybutimibe 10mg QD

• Study Type: Interventional
• Enrollment (Estimated): 520
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhiyuan Feng; Phone Number: 86-010-59975672; Email: fzyhhz1996@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Definite diagnosis of acute ischemic stroke or TIA.
• Age ≥18 and <75 years
• Time from onset (last known normal) to enrollment ≤ 72 hours.
• LDL-C level ≥ 1.8 mmol/L prior to enrollment (must obtain LDL-C value after onset to be randomized).

Exclusion Criteria:

• Use of high-intensity statins, cholesterol absorption inhibitors, PCSK9 inhibitors, or other small interfering RNA cholesterol-lowering drugs within 14 days prior to randomization.

• Suspected familial hypercholesterolemia.

• Suspected cardiogenic stroke (e.g., with atrial fibrillation, prosthetic heart valves, atrial myxoma, endocarditis).

• Acute ischemic stroke suspected to be caused by other etiologies (e.g., arterial dissection, vasculitis, vascular malformation).

• Presence of isolated sensory symptoms (e.g., numbness) only, isolated visual changes only, or isolated dizziness/vertigo only, in the absence of evidence of acute infarction on baseline head CT or MRI.

• Pre-stroke mRS score >2.

• High risk of cerebral hemorrhage (e.g., imaging indicates hemorrhagic transformation after the current stroke, or history of hemorrhagic stroke).

• Patients with risks or contraindications to statins or hybutimibe:

  1. Acute liver failure or decompensated cirrhosis.
  2. Known hypersensitivity to statins or hybutimibe.
  3. Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraceptive measures and have no documented pregnancy test.
  4. Use of immunosuppressants, azole antifungals, amiodarone, fibrates, or other medications that may affect statin metabolism within 14 days prior to randomization, or planned use of such medications during the study period.
  5. Hepatic or renal impairment (hepatic impairment defined as ALT >2× upper limit of normal [ULN] or AST >2× ULN; renal impairment defined as serum creatinine >1.5× ULN or estimated glomerular filtration rate [eGFR] <20 mL/min).
  6. Creatine kinase >5× ULN, or a personal or family history of hereditary muscle disease.

• Planned major surgery or interventional procedure within 8 weeks that may require interruption of the study drug.

• Severe organic disease with a life expectancy < 8 weeks.

• Currently participating in other investigational drug or device studies.

• Inability to complete the 8-week follow-up due to geographic or other reasons (e.g., dementia, severe paralysis, psychiatric disorders).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upfront combination Lipid Lowering Therapy; Patients will receive a combination of Atorvastatin (40 mg/day) and Hybutimibe (10 mg/day) immediately after enrollment, continuing for 8 weeks	Drug: Atorvastatin; 40 mg/day, administered orally; Drug: Hybutimibe 10mg QD; 10 mg/day, administered orally. Used upfront in the experimental group, and sequentially added in the active comparator group if the 4-week LDL-C target is not met.
Active Comparator: Sequential Lipid Lowering Therapy; Patients will receive Atorvastatin (40 mg/day) immediately after enrollment for 4 weeks. An LDL-C test will be performed at 4 weeks; if the target is achieved (<1.8 mmol/L and ≥50% reduction from baseline), the same regimen will continue until 8 weeks. If the target is not achieved, Hybutimibe (10 mg/day) will be added to the regimen until 8 weeks	Drug: Atorvastatin; 40 mg/day, administered orally; Drug: Hybutimibe 10mg QD; 10 mg/day, administered orally. Used upfront in the experimental group, and sequentially added in the active comparator group if the 4-week LDL-C target is not met.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients achieving the LDL-C target at 8 weeks	Defined as achieving an LDL-C level of <1.8 mmol/L and a reduction of ≥50% from baseline	at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage change in the lipid profile at 8 weeks	Evaluated by the least squares mean percentage change from baseline in LDL-C, non-HDL-C, TG, TC, Lp(a), and ApoB.	at 8 weeks
Percentage of patients achieving the general LDL-C target at 8 weeks	Defined as achieving an LDL-C level of <1.8 mmol/L at 8 weeks	at 8 weeks
Incidence of composite vascular events at 8 weeks	Including stroke (ischemic or hemorrhagic stroke), myocardial infarction, and cardiovascular death.	at 8 weeks
All-cause mortality rate at 8 weeks	Incidence of death from any cause during the study period	at 8 weeks
Stroke recurrence rate at 8 weeks	Incidence of recurrent stroke events during the follow-up period	at 8 weeks
Percentage of patients with a favorable functional outcome at 8 weeks	Defined as a modified Rankin Scale (mRS) score of 0 to 2	at 8 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 8 weeks	Defined as the occurrence of any of the following prespecified safety events: study drug discontinuation or dose reduction due to intolerance, newly diagnosed diabetes, muscle-related adverse events (myalgia, myopathy, muscle necrosis), elevated liver enzymes (ALT or AST > 3 times the upper limit of normal), or major bleeding events.	Up to 8 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Wannan Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: October 27, 2026
• First Posted (Actual): November 2, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: November 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Stroke; Ischemic Stroke; Ischemic Attack, Transient; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Azoles; Pyrroles; Heptanoic Acids; Atorvastatin
• Other Study ID Numbers: 20260528-Hybutimibe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No