Tirzepatide in Thrombectomy-Treated Acute Ischemic Stroke: A Randomized Trial
ConditionAcute Ischemic Stroke (AIS)
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age19-80
Sponsoryifang zhu
About this trial
Acute ischemic stroke caused by blockage of a large artery in the brain is one of the leading causes of death and long-term disability worldwide. For patients with this type of stroke, endovascular thrombectomy (EVT), a procedure that removes the blood clot and restores blood flow to the brain, has become the standard treatment. However, even when blood flow is successfully restored, many patients continue to experience disability because of ongoing brain injury caused by inflammation, oxidative stress, and damage to brain cells after the stroke.
This study aims to evaluate whether tirzepatide, a medication that activates both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) pathways, can improve recovery in patients with acute ischemic stroke caused by large vessel occlusion who receive thrombectomy. Tirzepatide is currently approved for the treatment of conditions such as type 2 diabetes and obesity. Previous studies have shown that tirzepatide can improve blood sugar control, reduce body weight, and provide beneficial effects on cardiovascular health. Laboratory studies and early clinical evidence suggest that medications targeting GLP-1 and GIP pathways may also have protective effects on the brain by reducing inflammation, protecting brain cells, improving blood vessel function, and supporting recovery after stroke.
In this study, eligible patients with acute ischemic stroke caused by blockage of a major brain artery will be randomly assigned to receive either tirzepatide plus standard stroke care or standard stroke care alone. Participants will receive two subcutaneous injections of tirzepatide: the first dose before the thrombectomy procedure and the second dose 7 days after the procedure. The study will include multiple hospitals and will use independent assessment of outcomes to ensure reliable evaluation of treatment effects.
The primary purpose of this study is to determine whether early treatment with tirzepatide can improve functional recovery 90 days after stroke, measured by the patient's ability to perform daily activities and live independently. The study will also evaluate whether tirzepatide is safe in patients with acute ischemic stroke by monitoring adverse events, complications, and other clinical outcomes.
The findings from this study may provide important evidence for a new treatment approach to improve recovery after thrombectomy and reduce disability among patients with severe ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years and ≤80 years;
Terminal ICA,
M1 segment of the middle cerebral artery, or
Dominant M2 segment;
Disqualifiers
Posterior-circulation large vessel occlusion stroke;
Receipt of intravenous thrombolysis prior to randomization;
Simultaneous bilateral anterior-circulation occlusions or concurrent anterior- and posterior-circulation occlusions;
ASPECTS <6,
Trial design
Design model
Parallel
Treatments tested in this trial
Tirzepatide
DrugParticipants will receive two subcutaneous injections of tirzepatide (5 mg each): the first administered before EVT and the second administered 7 days after EVT, in addition to standard medical care
Standard Medical Care (SMC)
Other interventionParticipants will receive EVT and standard medical care without tirzepatide.
Treatment groups
726 Participants
are divided into 2 treatment groupsGroup A: Tirzepatide Intervention GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary efficacy outcome: Proportion of patients achieving an excellent functional outcome
A excellent functional outcome is defined as modified Rankin Scale (mRS) score of 0-1 at 90 days. The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates symptoms without significant disability, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe disability, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes.
Time frame
90 ± 7 days after randomization2
The primary safety outcome: All-cause mortality
death from any cause within 90 days
Time frame
90 ± 7 daysSecondary outcomes
1
The secondary efficacy outcome: Distribution of mRS scores at 90 days after randomization
Ordinal Modified Rankin Scale (mRS) analysis. The Modified Rankin Scale ranges from 0 to 6, where 0 indicates no symptoms, 1 indicates symptoms without significant disability, 2 indicates slight disability, 3 indicates moderate disability, 4 indicates moderately severe disability, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes.
Time frame
90 ± 7 days2
The secondary efficacy outcome: Proportion of patients achieving an good functional outcome
A good functional outcome is defined as an Modified Rankin Scale (mRS) 0-2 at 90 days after randomization.
Time frame
90 ± 7 days3
The secondary safety outcome: Symptomatic intracranial hemorrhage (sICH)
defined by the Heidelberg Bleeding Classification within 48 hours after thrombectomy
Time frame
within 48 hours after thrombectomyOther outcomes
1
Early neurological improvement
Early neurological improvement defined as a reduction of ≥4 points in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 7 days. National Institutes of Health Stroke Scale (NIHSS) score. The NIHSS ranges from 0 to 42, with 0 indicating no neurological deficit and higher scores indicating more severe neurological impairment. Higher scores indicate worse neurological outcomes.
Time frame
7 ± 2 Days2
Recanalization rate of the target LVO vessel
Defined as the proportion of patients with successful recanalization of the target occluded vessel at 7 days after EVT or hospital discharge, whichever occurs first, among those achieving successful reperfusion after EVT (final mTICI score ≥2b).
Time frame
at 7 days after EVT or hospital discharge3
Health-related quality of life
Assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale ranging from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems or inability to perform the activity. Higher scores indicate worse health status.
Time frame
90 ± 7 days4
Early neurological deterioration
Early neurological deterioration defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale (NIHSS) score within 48 hours after randomization.
Time frame
within 48 hours after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
yifang zhu
Lead sponsor
Second Affiliated Hospital of Soochow University
Sponsor institution
Source ClinicalTrials.gov
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