Stroke, IschemicPhase 3INSIST-IT2NCT07135089
Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban
A Phase 3 study testing Intravenous tirofiban before endovascular thrombectomy in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
It remains uncertain whether intravenous tirofiban administered before endovascular thrombectomy could improve disability severity for patients with LVO due to intracranial atherosclerosis.The current study aimed to assess the efficacy and safety of administering intravenous tirofiban before endovascular thrombectomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Intravenous tirofiban before endovascular thrombectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 870 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to 30 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Anterior circulation large vessel occlusion (the internal carotid artery or the first or second segment of the middle cerebral artery) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA);
- Eligible for endovascular treatment within 12 hours of symptom onset;
- Based on the patient's medical history, clinical presentation, and imaging findings, large artery atherosclerosis is highly suspected as the underlying etiology;
- Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
- Baseline ASPECTS ≥ 6 on CT;
- A pre-stroke modified Rankin Scale (mRS) score of ≤2;
- Signed informed consent by patient or their legally authorized representative.
Who cannot join
- History of atrial fibrillation or atrial flutter, or 12-lead Electrocardiogram before randomization and after admission showing atrial flutter or atrial fibrillation;
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage, or a history of bleeding within one month;
- Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors;
- The following drugs are taken within one week: dual antiplatelet drugs, direct oral anticoagulants (DOACs), warfarin and other drugs that increase the risk of bleeding;
- Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- Deficiency of anticoagulant factors or international normalized ratio (INR) > 1.7, platelet count < 90×10⁹/L;;
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- Severe renal insufficiency and advanced disease with an expected life expectancy of less than 6 months;
- Pregnancy or lactation;
- Allergy to drugs or contrast agents;
- Participating in other clinical trials;
- Other conditions that the researcher deems unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Northern Theater Command
Shenyang, Liaoning, 110016
Liang Liu, +86-024-28897499, 18580763671@163.com
About this study
Official title: Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban (INSIST-IT2): a Prospective, Randomized, Double Blinded, Multi-center Study
It remains uncertain whether intravenous tirofiban administered before endovascular thrombectomy could improve disability severity for patients with LVO due to intracranial atherosclerosis.The current study aimed to assess the efficacy and safety of administering intravenous tirofiban before endovascular thrombectomy for improving clinical outcomes in patients with anterior circulation LVO due to intracranial atherosclerosis.
- Conditions
- Stroke, Ischemic
- Being tested
- Intravenous tirofiban before endovascular thrombectomy, Intravenous placebo before endovascular thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous tirofiban before endovascular thrombectomyDrug
The tirofiban was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours.
Intravenous placebo before endovascular thrombectomyDrug
The placebo was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Experimental | Intravenous tirofiban before endovascular thrombectomy Receives: Drug: Intravenous tirofiban before endovascular thrombectomy |
| Placebo group | Placebo comparator | Intravenous placebo before Endovascular Thrombectomy Receives: Drug: Intravenous placebo before endovascular thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2)
mRS ranges from 0-6, with high score meaning poor outcome
Measured: Day 90
Secondary outcomes (14)
The proportion of patients without disability (modified Rankin Scale [mRS] score of 0 to 1) or who returned to their premorbid mRS score at 90 days (for patients with prestroke mRS score >1)
mRS ranges from 0-6, with high score meaning poor outcome
Measured: Day 90
ordinal distribution of modified Rankin Scale (mRS)
mRS ranges from 0-6, with high score meaning poor outcome
Measured: Day 90
The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b)
Substantial reperfusion was defined as an expanded Thrombolysis In Cerebral Infarction grade of 2b50 (substantial reperfusion), 2c (nearcomplete reperfusion), or 3 (complete reperfusion).
Measured: immediately after first catheter angiogram
The proportions of patients with substantial reperfusion at final angiogram
Measured: immediately after final angiogram
The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment
Measured: 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS)
NIHSS ranges from 0-42, with high score meaning poor outcome
Measured: 24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)
NIHSS ranges from 0-42, with high score meaning poor outcome
Measured: 7 (-2/+2) days
The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification
Measured: 24 (-6/+24) hours
The incidence of intraparenchymal hemorrhage (PH1 and PH2)
Measured: 24 (-6/+24) hours
The incidence of non-intracranial hemorrhage complications
Measured: 24 (-6/+24) hours
Serious adverse events
eg, acute respiratory failure, large or malignant middle cerebral artery infarction, acute heart failure, hemicraniectomy
Measured: 7 (-2/+2) days
Procedure-associated complications
Measured: Periprocedural
The proportion of patients with thrombocytopenia
Measured: 24 (-6/+24) hours
The incidence of mortality
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start13 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 870 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135089
- Sponsor's protocol ID
- Y(2025)114
- Acronym
- INSIST-IT2
- Status last verified
- Dec 2025
- First submitted
- 12 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban (INSIST-IT2): a Prospective, Randomized, Double Blinded, Multi-center Study
- ClinicalTrials.gov ID
- NCT07135089
- Acronym / sponsor ID
- INSIST-IT2 / Y(2025)114
- Conditions
- Stroke, Ischemic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 870 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 21 Aug 2025 (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.
It remains uncertain whether intravenous tirofiban administered before endovascular thrombectomy could improve disability severity for patients with LVO due to intracranial atherosclerosis.The current study aimed to assess the efficacy and safety of administering intravenous tirofiban before endovascular thrombectomy for improving clinical outcomes in patients with anterior circulation LVO due to intracranial atherosclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban group | Experimental | Drug: Intravenous tirofiban before endovascular thrombectomyIntravenous tirofiban before endovascular thrombectomy |
| Placebo group | Placebo comparator | Drug: Intravenous placebo before endovascular thrombectomyIntravenous placebo before Endovascular Thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years;
- Anterior circulation large vessel occlusion (the internal carotid artery or the first or second segment of the middle cerebral artery) confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA);
- Eligible for endovascular treatment within 12 hours of symptom onset;
- Based on the patient's medical history, clinical presentation, and imaging findings, large artery atherosclerosis is highly suspected as the underlying etiology;
- Baseline National Institute of Health Stroke Scale (NIHSS) ≥ 6;
Key exclusion criteria (11 listed)
- History of atrial fibrillation or atrial flutter, or 12-lead Electrocardiogram before randomization and after admission showing atrial flutter or atrial fibrillation;
- Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage, or a history of bleeding within one month;
- Intracranial aneurysms or malformations, tortuous arteries that hinder thrombectomy, and space-occupying effect brain tumors;
- The following drugs are taken within one week: dual antiplatelet drugs, direct oral anticoagulants (DOACs), warfarin and other drugs that increase the risk of bleeding;
- Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
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 |
|---|---|---|
| Intravenous tirofiban before endovascular thrombectomyThe tirofiban was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours. | Drug | Tirofiban group |
| Intravenous placebo before endovascular thrombectomyThe placebo was administrated as a bolus dose of 10 μg/kg, followed by continuous infusion of 0.15 μg/kg/min for up to 24 hours. | Drug | Placebo group |
Primary outcome
The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2)
Time frame: Day 90
mRS ranges from 0-6, with high score meaning poor outcome
14 secondary outcomes
The proportion of patients without disability (modified Rankin Scale [mRS] score of 0 to 1) or who returned to their premorbid mRS score at 90 days (for patients with prestroke mRS score >1)
Time frame: Day 90
ordinal distribution of modified Rankin Scale (mRS)
Time frame: Day 90
The proportions of patients with substantial reperfusion at initial preprocedure catheter angiogram (defined as mTICI score ≥2b)
Time frame: immediately after first catheter angiogram
The proportions of patients with substantial reperfusion at final angiogram
Time frame: immediately after final angiogram
The proportions of patients with complete recanalization as assessed by CTA or MRA 48 hours after endovascular treatment
Time frame: 24 (-6/+24) hours
Change in National Institute of Health stroke scale (NIHSS)
Time frame: 24 (-6/+24) hours
change in National Institute of Health stroke scale (NIHSS)
Time frame: 7 (-2/+2) days
The incidence of symptomatic intracranial hemorrhage assessed according to Heidelberg bleeding classification
Time frame: 24 (-6/+24) hours
The incidence of intraparenchymal hemorrhage (PH1 and PH2)
Time frame: 24 (-6/+24) hours
The incidence of non-intracranial hemorrhage complications
Time frame: 24 (-6/+24) hours
Serious adverse events
Time frame: 7 (-2/+2) days
Procedure-associated complications
Time frame: Periprocedural
The proportion of patients with thrombocytopenia
Time frame: 24 (-6/+24) hours
The incidence of mortality
Time frame: Day 90
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 9 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous tirofiban before endovascular thrombectomy in people with Stroke, Ischemic, run by General Hospital of Shenyang Military Region at 1 site in China.
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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Hui-Sheng Chen (+86-024-28897511, chszh@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with functional independence (modified Rankin Scale [mRS] score of 0 to 2) (time frame: Day 90). 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 9 Dec 2025.