Ischemia StrokePhase 3NCT07908875
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
A Phase 3 study testing Atorvastatin and Hybutimibe 10mg QD in people with Ischemia Stroke and TIA (Transient Ischemic Attack), run by First Affiliated Hospital of Wannan Medical College.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemia Stroke, TIA (Transient Ischemic Attack)
- What is being tested?
- Atorvastatin and Hybutimibe 10mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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:
- Acute liver failure or decompensated cirrhosis.
- Known hypersensitivity to statins or hybutimibe.
- Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraceptive measures and have no documented pregnancy test.
- 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.
- 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).
- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
- Conditions
- Ischemia Stroke, TIA (Transient Ischemic Attack)
- Being tested
- Atorvastatin, Hybutimibe 10mg QD
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
40 mg/day, administered orally
Hybutimibe 10mg QDDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Upfront combination Lipid Lowering Therapy | Experimental | Patients will receive a combination of Atorvastatin (40 mg/day) and Hybutimibe (10 mg/day) immediately after enrollment, continuing for 8 weeks Receives: Drug: Atorvastatin; Drug: Hybutimibe 10mg QD |
| Sequential Lipid Lowering Therapy | Active comparator | 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 Receives: Drug: Atorvastatin; Drug: Hybutimibe 10mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 8 weeks
Secondary outcomes (7)
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.
Measured: 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
Measured: at 8 weeks
Incidence of composite vascular events at 8 weeks
Including stroke (ischemic or hemorrhagic stroke), myocardial infarction, and cardiovascular death.
Measured: at 8 weeks
All-cause mortality rate at 8 weeks
Incidence of death from any cause during the study period
Measured: at 8 weeks
Stroke recurrence rate at 8 weeks
Incidence of recurrent stroke events during the follow-up period
Measured: 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
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Wannan Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Xu, First Affiliated Hospital of Wannan Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908875
- Sponsor's protocol ID
- 20260528-Hybutimibe
- Status last verified
- Jul 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
- ClinicalTrials.gov ID
- NCT07908875
- Acronym / sponsor ID
- 20260528-Hybutimibe
- Conditions
- Ischemia Stroke, TIA (Transient Ischemic Attack)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wannan Medical CollegeUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upfront combination Lipid Lowering Therapy | Experimental | Drug: Atorvastatin, Drug: Hybutimibe 10mg QDPatients will receive a combination of Atorvastatin (40 mg/day) and Hybutimibe (10 mg/day) immediately after enrollment, continuing for 8 weeks |
| Sequential Lipid Lowering Therapy | Active comparator | Drug: Atorvastatin, Drug: Hybutimibe 10mg QDPatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin40 mg/day, administered orally | Drug | Sequential Lipid Lowering Therapy, Upfront combination Lipid Lowering Therapy |
| Hybutimibe 10mg QD10 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. | Drug | Sequential Lipid Lowering Therapy, Upfront combination Lipid Lowering Therapy |
Primary outcome
Percentage of patients achieving the LDL-C target at 8 weeks
Time frame: at 8 weeks
Defined as achieving an LDL-C level of <1.8 mmol/L and a reduction of ≥50% from baseline
7 secondary outcomes
Percentage change in the lipid profile at 8 weeks
Time frame: at 8 weeks
Percentage of patients achieving the general LDL-C target at 8 weeks
Time frame: at 8 weeks
Incidence of composite vascular events at 8 weeks
Time frame: at 8 weeks
All-cause mortality rate at 8 weeks
Time frame: at 8 weeks
Stroke recurrence rate at 8 weeks
Time frame: at 8 weeks
Percentage of patients with a favorable functional outcome at 8 weeks
Time frame: at 8 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 8 weeks
Time frame: Up to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin and Hybutimibe 10mg QD in people with Ischemia Stroke and TIA (Transient Ischemic Attack), run by First Affiliated Hospital of Wannan Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiyuan Feng (86-010-59975672, fzyhhz1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients achieving the LDL-C target at 8 weeks (time frame: at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.