Acute StrokePhase 2/3TRENDNCT04491695
Tirofiban for the Prevention of Neurological Deterioration in Acute Ischemic Stroke
A Phase 2/3 study testing Tirofiban Hydrochloride and Oral antiplatelet in people with Acute Stroke, run by Capital Medical University at 19 sites in China.
Trial summary
Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Tirofiban Hydrochloride and Oral antiplatelet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 19 sitesChina
- Study dates
- 12 Sep 2020to 31 Mar 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke with 24 hours of symptom onset.
- NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
- Age 18-80 years old.
- Informed consent obtained from patient or acceptable patient's surrogate.
Who cannot join
- Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
- Acute ischemic stroke caused by determined or suspected cardioembolism.
- Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
- Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
- Known hematochezia, gastrointestinal bleeding and any other bleeding.
- Allergy to tirofiban or its solvents.
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- Patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc.
- Gastrointestinal or genitourinary tract bleeding within 1 years.
- Determined coagulation disorders, platelet dysfunction, or platelet count <100*109/L.
- Major surgical operation or severe trauma within 1 month.
- Hemorrhagic retinopathy.
- Chronic hemodialysis.
- Uncontrolled hypertension with systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg.
- Acute pericarditis.
- Other conditions that determined by the investigators.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites, 15 recruiting
- Recruiting
Sinapharm North Hospital
Baotou, Inner Mongolia
Lifei Xing, M.D.
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Qingfeng Ma, M.D.
Wenbo Zhao, M.D.
- Not yet recruiting
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality
Huishan Du, M.D.
Xiaokun Geng, M.D.
- Not yet recruiting
Hunan Provincial People's Hospital
Changsha, Hunan
Xiaoping Gao, M.D.
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Bo Wu, M.D.
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Qinjian Sun, M.D.
- Active, not recruiting
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
- Not yet recruiting
The first Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Junqiang Yan, M.D.
- Active, not recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Yu Xu, M.D.
- Recruiting
Nanyang Central Hospital
Nanyang, Henan
Changming Wen, M.D.
- Recruiting
Nanyang Second General Hospital
Nanyang, Henan
Jinhui Qin, M.D.
- Recruiting
Ordos Central Hospital
Ordos, Inner Mongolia
Xiaojun Hao
- Recruiting
Beichen Hospital of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Ruixian Wang, M.D.
- Active, not recruiting
TEDA Hospital
Tianjin, Tianjin Municipality
- Recruiting
Tongliao City Hosptial
Tongliao, Inner Mongolia
Yaoming Xu, M.D.
- Active, not recruiting
The Third People's Hospital of Hubei Province
Wuhan, Hubei
- Not yet recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yuming Xu
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Ziliang Wang, M.D.
About this study
Official title: Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.
- Conditions
- Acute Stroke
- Being tested
- Tirofiban Hydrochloride, Oral antiplatelet
- Keywords
- Acute ischemic stroke, Neurological deterioration, Stroke progression
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirofiban HydrochlorideDrug
Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
Oral antiplateletDrug
Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban+Oral antiplatelet therapy | Experimental | Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter. Receives: Drug: Tirofiban Hydrochloride; Drug: Oral antiplatelet |
| Oral antiplatelet therapy | Active comparator | Patients will receive oral antiplatelet therapy alone. Receives: Drug: Oral antiplatelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Measured: Within 72 hours of intervention.
Secondary outcomes (5)
Change of the NIHSS
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Measured: 0-30 days of intervention.
Change of the Scandinavian Stroke Scale
Scandinavian Stroke Scale (SSS): stroke symptom severity scale with a range of 0-58. Lower score means more severe stroke symptoms.
Measured: 0-30 days of intervention.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death).
Measured: 0-90 days.
Rate of symptomatic intracerebral hemorrhage.
Measured: 0-90 days
Number of Participants experienced adverse events
Measured: 0-90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start12 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491695
- Sponsor's protocol ID
- TREND
- Acronym
- TREND
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
PubMed 31570084Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.
PubMed 29127270Qiao Y, Zhao M, Wang J, Li S, Yang T, Wang P, Ji X, Ma Q, Zhao W. Stroke etiology was associated with tirofiban efficacy in acute ischemic stroke without endovascular treatment: A pre-specified subgroup analysis of the TREND trial. Int J Stroke. 2025 Oct;20(8):977-986. doi: 10.1177/17474930251326423. Epub 2025 Feb 27.
PubMed 40012523Wang J, Qiao Y, Li S, Li C, Wu C, Wang P, Yang T, Ji X, Ma Q, Zhao W. Effects of tirofiban in preventing neurological deterioration in acute ischemic stroke with intracranial artery stenosis: A post hoc analysis of the TREND Trial. Eur Stroke J. 2025 Sep;10(3):919-928. doi: 10.1177/23969873251319151. Epub 2025 Feb 14.
PubMed 39950764Wang J, Li S, Li C, Wu C, Song H, Ma Q, Ji X, Zhao W; TREND Investigators. Safety and efficacy of tirofiban in preventing neurological deterioration in acute ischemic stroke (TREND): Protocol for an investigator-initiated, multicenter, prospective, randomized, open-label, masked endpoint trial. Brain Circ. 2024 Jun 26;10(2):168-173. doi: 10.4103/bc.bc_93_23. eCollection 2024 Apr-Jun.
PubMed 39036300Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
PubMed 38648030
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tirofiban in Preventing Neurological Deterioration of Patients With Acute Ischemic Stroke: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04491695
- Acronym / sponsor ID
- TREND / TREND
- Conditions
- Acute Stroke
- Keywords
- Acute ischemic stroke, Neurological deterioration, Stroke progression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 29 Jul 2020 (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.
Currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. However, immediate, potent and reversible inhibition of platelet aggregation is not possible. Additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. Therefore, an intravenously administered GPIIb/IIIa receptor inhibitor (Tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. This study will measure the anti-platelet effects of Tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban+Oral antiplatelet therapy | Experimental | Drug: Tirofiban Hydrochloride, Drug: Oral antiplateletPatients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter. |
| Oral antiplatelet therapy | Active comparator | Drug: Oral antiplateletPatients will receive oral antiplatelet therapy alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute ischemic stroke with 24 hours of symptom onset.
- NIHSS≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher).
- Age 18-80 years old.
- Informed consent obtained from patient or acceptable patient's surrogate.
Key exclusion criteria (15 listed)
- Treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke.
- Acute ischemic stroke caused by determined or suspected cardioembolism.
- Acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc.
- Pre-stroke mRS ≥2 or the paralyzed limbs are dyskinesia before stroke.
- Known hematochezia, gastrointestinal bleeding and any other bleeding.
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 |
|---|---|---|
| Tirofiban HydrochlorideTirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours. | Drug | Tirofiban+Oral antiplatelet therapy |
| Oral antiplateletAspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy. | Drug | Oral antiplatelet therapy, Tirofiban+Oral antiplatelet therapy |
Primary outcome
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS.
Time frame: Within 72 hours of intervention.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
5 secondary outcomes
Change of the NIHSS
Time frame: 0-30 days of intervention.
Change of the Scandinavian Stroke Scale
Time frame: 0-30 days of intervention.
The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).
Time frame: 0-90 days.
Rate of symptomatic intracerebral hemorrhage.
Time frame: 0-90 days
Number of Participants experienced adverse events
Time frame: 0-90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Background: PubMed 31570084Wu C, Sun C, Wang L, Lian Y, Xie N, Huang S, Zhao W, Ren M, Wu D, Ding J, Song H, Wang Y, Ma Q, Ji X. Low-Dose Tirofiban Treatment Improves Neurological Deterioration Outcome After Intravenous Thrombolysis. Stroke. 2019 Dec;50(12):3481-3487. doi: 10.1161/STROKEAHA.119.026240. Epub 2019 Oct 1.
- Results publication: PubMed 29127270Zhao W, Che R, Shang S, Wu C, Li C, Wu L, Chen J, Duan J, Song H, Zhang H, Ling F, Wang Y, Liebeskind D, Feng W, Ji X. Low-Dose Tirofiban Improves Functional Outcome in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy. Stroke. 2017 Dec;48(12):3289-3294. doi: 10.1161/STROKEAHA.117.019193. Epub 2017 Nov 10.
- Derived from this study: PubMed 40012523Qiao Y, Zhao M, Wang J, Li S, Yang T, Wang P, Ji X, Ma Q, Zhao W. Stroke etiology was associated with tirofiban efficacy in acute ischemic stroke without endovascular treatment: A pre-specified subgroup analysis of the TREND trial. Int J Stroke. 2025 Oct;20(8):977-986. doi: 10.1177/17474930251326423. Epub 2025 Feb 27.
- Derived from this study: PubMed 39950764Wang J, Qiao Y, Li S, Li C, Wu C, Wang P, Yang T, Ji X, Ma Q, Zhao W. Effects of tirofiban in preventing neurological deterioration in acute ischemic stroke with intracranial artery stenosis: A post hoc analysis of the TREND Trial. Eur Stroke J. 2025 Sep;10(3):919-928. doi: 10.1177/23969873251319151. Epub 2025 Feb 14.
- Derived from this study: PubMed 39036300Wang J, Li S, Li C, Wu C, Song H, Ma Q, Ji X, Zhao W; TREND Investigators. Safety and efficacy of tirofiban in preventing neurological deterioration in acute ischemic stroke (TREND): Protocol for an investigator-initiated, multicenter, prospective, randomized, open-label, masked endpoint trial. Brain Circ. 2024 Jun 26;10(2):168-173. doi: 10.4103/bc.bc_93_23. eCollection 2024 Apr-Jun.
- Derived from this study: PubMed 38648030Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
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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. This study is not recruiting at the moment.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tirofiban Hydrochloride and Oral antiplatelet in people with Acute Stroke, run by Capital Medical University at 19 sites 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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qingfeng Ma, M.D. (010-83199430, m.qingfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a change in NIHSS by ≥ 4 points compared to enrollment NIHSS. (time frame: Within 72 hours of intervention.). 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 NCT04491695, which also lists 6 linked publications.
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 19 Jul 2022.