ClinicalTrials.gg
Sign In
Not yet recruitingNCT07908875Updated Nov 4, 2026

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

A Phase 3 interventional study of Atorvastatin and Hybutimibe 10mg QD in Ischemia Stroke and TIA (Transient Ischemic Attack), sponsored by First Affiliated Hospital of Wannan Medical College. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by First Affiliated Hospital of Wannan Medical College · Phase 3, Interventional, and Treatment

Updated Nov 4, 2026Eligibility revisedNewly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
520
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 transient ischemic attack (TIA)

02

Conditions studied

  • Ischemia Stroke
  • TIA (Transient Ischemic Attack)
03

In context

Ischemic Stroke

2,679 studies on the registry are indexed under Ischemic Stroke; 959 are open to participants now.

This study's planned enrollment of 520 is above the median of 120 across 1,818 interventional studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

First Affiliated Hospital of Wannan Medical College is the lead sponsor of 37 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 4, 2026. See what changed

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
520 participants (estimated)

Study arms

  • 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 · Drug: Hybutimibe 10mg QD

  • 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 · Drug: Hybutimibe 10mg QD

Interventions

  • DrugAtorvastatin

    40 mg/day, administered orally

  • DrugHybutimibe 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at 8 weeks

Secondary outcomes

  1. 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.

    Time frame: at 8 weeks

  2. 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

    Time frame: at 8 weeks

  3. Incidence of composite vascular events at 8 weeks

    Including stroke (ischemic or hemorrhagic stroke), myocardial infarction, and cardiovascular death.

    Time frame: at 8 weeks

  4. All-cause mortality rate at 8 weeks

    Incidence of death from any cause during the study period

    Time frame: at 8 weeks

  5. Stroke recurrence rate at 8 weeks

    Incidence of recurrent stroke events during the follow-up period

    Time frame: at 8 weeks

  6. Percentage of patients with a favorable functional outcome at 8 weeks

    Defined as a modified Rankin Scale (mRS) score of 0 to 2

    Time frame: at 8 weeks

  7. 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.

    Time frame: Up to 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2027, 10 months later.

Of 144 non-industry phase 3 interventional studies under Ischemic Stroke, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 66. This study's planned 10 months is below that.

Counting every sponsor, half of 167 studies reached it within 28 months; a quarter within 19 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2026
First posted
Nov 2, 2026
StartEst.
Nov 30, 2026
Primary completionEst.
Sep 30, 2027
CompletionEst.
Dec 31, 2027
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Eligibility
3 exclusion criteria edited, 4 added
What changed in the criteria
Exclusion criteria
  • AddedAcute liver failure or decompensated cirrhosis.
  • AddedKnown hypersensitivity to statins or hybutimibe.
  • EditedAcute 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.
  • Edited9.Planned major surgery or interventional procedure within 8 weeks that may require interruption of the study drug.
  • AddedSevere organic disease with a life expectancy < 8 weeks.
  • AddedCurrently participating in other investigational drug or device studies.
  • Edited10.Severe organic disease with a life expectancy < 8 weeks. 11.Currently participating in other investigational drug or device studies. 12.Inability to complete the 8-week follow-up due to geographic or other reasons (e.g., dementia, severe paralysis, psychiatric disorders).
Nov 4, 2026
Secondary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Incidence of safety events up to 8 weeksNow Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 8 weeksTime frame: Up to 8 weeks
Nov 4, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 4, 2026
    Eligibility 3 exclusion criteria edited, 4 added
    What changed in the criteria
    Exclusion criteria
    • AddedAcute liver failure or decompensated cirrhosis.
    • AddedKnown hypersensitivity to statins or hybutimibe.
    • EditedAcute 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.
    • Edited9.Planned major surgery or interventional procedure within 8 weeks that may require interruption of the study drug.
    • AddedSevere organic disease with a life expectancy < 8 weeks.
    • AddedCurrently participating in other investigational drug or device studies.
    • Edited10.Severe organic disease with a life expectancy < 8 weeks. 11.Currently participating in other investigational drug or device studies. 12.Inability to complete the 8-week follow-up due to geographic or other reasons (e.g., dementia, severe paralysis, psychiatric disorders).
    Secondary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Incidence of safety events up to 8 weeksNow Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 8 weeksTime frame: Up to 8 weeks
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07908875
Lead sponsor
First Affiliated Hospital of Wannan Medical College
Responsible party
Jie Xu (professor, First Affiliated Hospital of Wannan Medical College) — Principal investigator
First posted
Nov 2, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Sep 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 4, 2026

Study contacts

Zhiyuan Feng
Contact
fzyhhz1996@gmail.com
86-010-59975672

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Atorvastatin

Other studies in this condition

Ischemic Stroke →

Other studies from this sponsor

First Affiliated Hospital of Wannan Medical College

Start the discussion