Acute Ischemic StrokeNCT06045156
Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke
A study testing Tirofiban and Tirofiban simulant in people with Acute Ischemic Stroke, run by The First Hospital of Jilin University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Tirofiban and Tirofiban simulant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,084 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2024to 30 Dec 2026
- Phase
- Interventional
- 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 old;
- Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
- Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
- Tirofiban or placebo treatment can be initiated within 6h after IVT;
- mRS score before onset≤ 1;
- Intracranial hemorrhage is ruled out by CT head after IVT;
Who cannot join
- Received or plan to undergo bridge therapy;
- Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
- Atrial fibrillation or suspected cardiac embolism;
- Accompanied by epileptic seizures;
- Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
- Active bleeding or tendency to bleed after receipt of intravenous thrombolysis;
Show all 14Show fewer
- Digestive system bleeding, urinary system bleeding, hemorrhagic retinopathy or other systemic bleeding events within 1 year;
- Severe renal or liver insufficiency; ALT or AST>3 times of the upper limit of normal value or above; creatinine clearance rate<30 mL/min, creatinine>200μmol/L；
- Life expectancy less than 3 months;
- Pregnant or lactating women;
- Known allergy to tirofiban;
- Being enrolled or having been enrolled in other clinical trial within 3 months prior to this clinical trial.;
- Patients who are unwilling to be followed up or likely to have poor treatment compliance;
- Other situations that the researcher deems unsuitable for inclusion in the 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
The first hospital of Jilin University
Changchun, Jilin, 130000
Yi Yang, MD, PhD, 13756661217, doctoryangyi@163.com
About this study
Official title: Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
Read the detailed description
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.
Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban, Tirofiban simulant
- Keywords
- acute ischemic stroke, intravenous thrombolysis, tirofiban
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirofibanDrug
Tirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation
Tirofiban simulantDrug
Tirofiban simulant is placebo packed the same style as tirofiban
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban group | Active comparator | Tirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT Receives: Drug: Tirofiban |
| Tirofiban simulant group | Placebo comparator | Tirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT Receives: Drug: Tirofiban simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients of modified Rankin Scale (mRS)≤1
mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome
Measured: 90±7 days
Secondary outcomes (3)
Proportion of patients of mRS≤2
mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-2 represents favorable functional outcome
Measured: 90±7 days
Distribution of mRS
mRS depicts functional outcome of stroke, which ranges from 0-6
Measured: 90±7 days
National Institute of Health stroke scale (NIHSS)
National Institute of Health stroke scale (NIHSS) ranges from 0 to 42, a low value represents a better outcome
Measured: 24 hours after IVT, 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Apr 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,084 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045156
- Sponsor's protocol ID
- ADVENT
- Status last verified
- Dec 2025
- First submitted
- 13 Sep 2023
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.
PubMed 38196129
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Tirofiban Administration After Intravenous Thrombolysis in Acute Ischemic Stroke: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06045156
- Acronym / sponsor ID
- ADVENT
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, intravenous thrombolysis, tirofiban
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,084 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
The purpose of this study is to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT
Detailed description
Nearly half of acute ischemic stroke patients underwent intravenous thrombolysis (IVT) failed to achieve excellent functional outcome. Some studies reported that early administrated tirofiban, a selective glycoproteinⅡb/Ⅲa receptor inhibitor, may greatly improve the outcome of patients who received IVT, however they only recruited small sample size.
Thus, the investigators design early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT) trial, aiming to evaluate the efficacy and safety of early tirofiban administration in patients undergoing IVT.
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 | Active comparator | Drug: TirofibanTirofiban infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT |
| Tirofiban simulant group | Placebo comparator | Drug: Tirofiban simulantTirofiban simulant infused with 0.4μg/kg/min for 30min and 0.1μg/kg/min until 24h after IVT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥18 years old;
- Clinically diagnosed as acute ischemic stroke and received standard dose (0.25mg/kg) of tenecteplase IVT within 4.5 hours of onset;
- Total National Institute of Health stroke scale (NIHSS)≥4 or single limb motor item score≥2, and total NIHSS≤15 after IVT;
- Tirofiban or placebo treatment can be initiated within 6h after IVT;
- mRS score before onset≤ 1;
Key exclusion criteria (14 listed)
- Received or plan to undergo bridge therapy;
- Large area of infarct indicated by radiological imaging(≥1/3 of middle cerebral artery supply area);
- Atrial fibrillation or suspected cardiac embolism;
- Accompanied by epileptic seizures;
- Using antiplatelet, anticoagulant or fibrinolytic agents within 24h before recruitment;
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 |
|---|---|---|
| TirofibanTirofiban is a selective glycoproteinⅡb/Ⅲa receptor inhibitor, which inhibits platelet aggregation and thrombi formation | Drug | Tirofiban group |
| Tirofiban simulantTirofiban simulant is placebo packed the same style as tirofiban | Drug | Tirofiban simulant group |
Primary outcome
Proportion of patients of modified Rankin Scale (mRS)≤1
Time frame: 90±7 days
mRS depicts functional outcome of stroke, which ranges from 0-6, mRS 0-1 represents excellent functional outcome
3 secondary outcomes
Proportion of patients of mRS≤2
Time frame: 90±7 days
Distribution of mRS
Time frame: 90±7 days
National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours after IVT, 7 days
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 30 Dec 2025.
- Derived from this study: PubMed 38196129Guo ZN, Zhang KJ, Zhang P, Qu Y, Abuduxukuer R, Nguyen TN, Chen HS, Yang Y. Early tirofiban administration after intravenous thrombolysis in acute ischemic stroke (ADVENT): Study protocol of a multicenter, randomized, double-blind, placebo-controlled clinical trial. Eur Stroke J. 2024 Jun;9(2):510-514. doi: 10.1177/23969873231225069. Epub 2024 Jan 9.
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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 study testing Tirofiban and Tirofiban simulant in people with Acute Ischemic Stroke, run by The First Hospital of Jilin University 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 6 inclusion and 14 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 30 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients of modified Rankin Scale (mRS)≤1 (time frame: 90±7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06045156, which also lists 1 linked publication.
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 30 Dec 2025.