Acute StrokePhase 2/3TREND-2NCT06587347
Tirofiban for the Prevention of Early Neurological Deterioration After Intravenous Thrombolysis in Acute Ischemic Stroke
A Phase 2/3 study testing Tirofiban Hydrochloride and Standard medical treatment (SMT) in people with Acute Stroke and Ischemic Stroke, Acute, run by Capital Medical University at 1 site in China.
Trial summary
A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, Ischemic Stroke, Acute, Cerebral Infarction
- What is being tested?
- Tirofiban Hydrochloride and Standard medical treatment (SMT)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old;
- Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
- Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).
- Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%~99%)
- Informed consent obtained from patients or their acceptable surrogates.
Who cannot join
- Intracranial hemorrhage confirmed by imaging post-thrombolysis.
- Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.
- Scheduled for or received endovascular treatment after onset.
- Definite or suspected cardioembolic stroke.
- Definite anticipation of developing indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state).
- Use of antiplatelet or anticoagulant therapy within one week pre-stroke.
Show all 23Show fewer
- Pre-stroke mRS score ≥ 2.
- Severe consciousness disturbance with NIHSS item 1a (level of consciousness) >1 point at randomization.
- History of tirofiban allergy or its solvents.
- History of platelet count < 100 × 109/L caused by tirofiban.
- Major surgical operation within 6 weeks.
- Major systemic hemorrhage within 30 days;
- Determined coagulation disorders, platelet dysfunction, or platelet count < 100*109/L.
- Currently pregnant or lactating;
- Uncontrolled hypertension with systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg.
- Acute pericarditis or hemorrhagic retinopathy.
- Presence of malignant tumors, chronic hemodialysis, severe renal insufficiency (GFR < 30 ml/min or serum Cr > 220 μmol/L (2.5 mg/dl)), severe hepatic insufficiency (serum ALT > 2 times the upper limit of normal, or serum AST > 2 times the upper limit of normal), severe heart failure (NYHA class III or IV).
- Severe non-cardiovascular complications with an expected survival of less than 6 months.
- Unavailability for follow-up.
- Presence of dementia, psychiatric disorders, or other known neurological conditions that complicate follow-up.
- Participated in this study in the past.
- Current participation in another therapeutic study with ongoing treatment and follow-up.
- Other conditions that are not suitable for participation in this study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Wenbo Zhao, MD, PD, 010-8319-9048, zhaowb@xwh.ccmu.edu.cn
About this study
Official title: Effects of Tirofiban on Early Neurological Deterioration After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: an Open-label, Multicenter, Randomized Controlled Trial
A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.
Read the detailed description
Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA), administered within 4.5 hours of symptom onset, remains the standard treatment strategy for acute ischemic stroke. However, approximately 6-40% of patients experienced early neurological deterioration following intravenous thrombolysis, among which more than 70% resulted from ischemic events, with 20-34% due to early re-occlusion of the recanalized artery. Augmented platelet activation, triggered by the activated coagulation cascade and endothelial injury during rt-PA administration, is recognized as one of the primary reasons for ischemic events after intravenous thrombolysis. Early antiplatelet therapy following rt-PA effectively reduces neurological deterioration and improves functional outcomes. However, the current guidelines recommend that antiplatelet therapy should be initiated 24 hours after intravenous thrombolysis due to the potential risk of intracerebral hemorrhage.
Tirofiban, a glycoprotein (GP) IIb/IIIa receptor inhibitor renowned for its rapid action, high selectivity, and short half-life, has been found to exert a remarkable antiplatelet effect by effectively blocking the terminal pathway that triggers platelet aggregation. One recent randomized trial found that among patients with acute non-cardioembolic ischemic stroke who presented within 24 hours of symptom onset, intravenous tirofiban resulted in a lower likelihood of early neurological deterioration than oral aspirin, without increasing the risk of intracranial hemorrhage or systematic bleeding. Another randomized trial found that treatment with intravenous tirofiban administration was safe and significantly improved 3-month functional outcomes in patients who experienced early neurological deterioration or no improvement within 24 hours of intravenous thrombolysis, compared with aspirin. Furthermore, our previous study found that early administration of tirofiban in patients with early neurological deterioration within the first 24 hours of intravenous thrombolysis did not increase the risk of symptomatic intracerebral hemorrhage, any intracerebral hemorrhage, or mortality. In contrast, it was associated with neurological improvement at 3 months. However, whether early administration of tirofiban can safely and effectively prevent neurological deterioration in patients with acute ischemic stroke treated with intravenous thrombolysis within 24 hours remains unclear, while the subset of patients who may benefit from early antiplatelet therapy.
- Conditions
- Acute Stroke, Ischemic Stroke, Acute, Cerebral Infarction
- Being tested
- Tirofiban Hydrochloride, Standard medical treatment (SMT)
- Keywords
- Acute ischemic stroke, Neurological deterioration, Stroke progression, intravenous thrombolysis, Antiplatelet therapy
- Medical subject headings
- Stroke, Ischemic Stroke, Cerebral Infarction
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 until 24 hours after Intravenous thrombolytic therapy, or use a loading dose, 25 μg/kg, administrated within 3 minutes, then 0.15μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy.
Standard medical treatment (SMT)Drug
Patients will receive standard antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban Group | Experimental | Patients will receive tirofiban in the first 24 hours after intravenous thrombolysis, then bridge to oral antiplatelet therapy. Receives: Drug: Tirofiban Hydrochloride |
| Control group | Active comparator | Aspirin, clopidogrel, or other antiplatelet drugs will be used in principle after 24 hours of thrombolytic therapy or until the primary outcome occurs. Receives: Drug: Standard medical treatment (SMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients experiencing neurological deterioration within 24 hours after intravenous thrombolysis.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale ranging from 0-42. A higher score means more severe stroke symptoms. Neurological deterioration is defined as an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS.
Measured: Within 24 hours after intravenous thombolysis.
Secondary outcomes (17)
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: 7 days or discharge after intravenous thrombolytic therapy
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.
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: 30 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.
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: 90 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 30-day follow up.
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: 30 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up.
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: 90 days after stroke
Distribution of modified Rankin Scale (mRS) scores at 90 day.
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: 90 days after stroke
Incidence of symptomatic intracranial hemorrhage within 24 hours of intervention.
Symptomatic intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging leading to an increase of at least 4 points in the NIHSS score, according to the criteria of the European Cooperative Acute Stroke Study III (ECASS III).
Measured: Within 24 hours of intervention
Incidence of any intracranial hemorrhage within 24 hours of intervention.
Any intracranial hemorrhage is defined as the demonstration of hemorrhage within brain parenchyma on head imaging, according to the criteria of the ECASS III.
Measured: Within 24 hours of intervention
Incidence of systemic hemorrhage within 90 days after stroke.
The incidence of systemic hemorrhage at any time from randomization through day 90, according to the criteria of the GUSTO.
Measured: Within 90 days after stroke.
Incidence of recurrent stroke or other vascular events within 90 days after stroke.
The incidence of recurrent stroke or other vascular events (including hemorrhagic and ischemic stroke, myocardial infarction, and cardiovascular death) within 90 days of randomization.
Measured: Within 90 days after stroke.
All-cause death within 90 days after stroke.
The incidence of death events at any time from randomization through day 90.
Measured: Within 90 days after stroke.
Incidence of Adverse Events/Serious Adverse Events within 90 days after stroke.
The incidence of other adverse events and serious adverse events at any time from randomization through day 90.
Measured: Within 90 days after stroke.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 2 points compared to the lowest NIHSS) within 24 hours after intravenous thrombolysis.
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 24 hours of intravenous thrombolysis.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 48 hours after intravenous thrombolysis.
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 48 hours after intravenous thrombolysis.
Proportion of patients experiencing (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 72 hours after intravenous thrombolysis.
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 after intravenous thrombolysis.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 7 days after intravenous thrombolysis.
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 7 days after intravenous thrombolysis.
Proportion of patients with a decrease in NIHSS by ≥ 2 points compared to NIHSS at randomization.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale with a range of 0-42. Higher score means more severe stroke symptoms.
Measured: 24 hours after intravenous thrombolysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06587347
- Sponsor's protocol ID
- TREND-2
- Acronym
- TREND-2
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao 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 38648030Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
PubMed 37256974Wu 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 31570084
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tirofiban on Early Neurological Deterioration After Intravenous Thrombolysis in Patients With Acute Ischemic Stroke: an Open-label, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06587347
- Acronym / sponsor ID
- TREND-2 / TREND-2
- Conditions
- Acute Stroke, Ischemic Stroke, Acute, Cerebral Infarction
- Keywords
- Acute ischemic stroke, Neurological deterioration, Stroke progression, intravenous thrombolysis, Antiplatelet therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 20 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
A prospective, multicenter, randomized, controlled, open-label, blinded endpoint trial to evaluate the safety and efficacy of intravenous administration of tirofiban for preventing early neurological deterioration after intravenous thrombolysis in patients with acute ischemic stroke.
Detailed description
Intravenous thrombolysis with recombinant tissue plasminogen activator (rt-PA), administered within 4.5 hours of symptom onset, remains the standard treatment strategy for acute ischemic stroke. However, approximately 6-40% of patients experienced early neurological deterioration following intravenous thrombolysis, among which more than 70% resulted from ischemic events, with 20-34% due to early re-occlusion of the recanalized artery. Augmented platelet activation, triggered by the activated coagulation cascade and endothelial injury during rt-PA administration, is recognized as one of the primary reasons for ischemic events after intravenous thrombolysis. Early antiplatelet therapy following rt-PA effectively reduces neurological deterioration and improves functional outcomes. However, the current guidelines recommend that antiplatelet therapy should be initiated 24 hours after intravenous thrombolysis due to the potential risk of intracerebral hemorrhage.
Tirofiban, a glycoprotein (GP) IIb/IIIa receptor inhibitor renowned for its rapid action, high selectivity, and short half-life, has been found to exert a remarkable antiplatelet effect by effectively blocking the terminal pathway that triggers platelet aggregation. One recent randomized trial found that among patients with acute non-cardioembolic ischemic stroke who presented within 24 hours of symptom onset, intravenous tirofiban resulted in a lower likelihood of early neurological deterioration than oral aspirin, without increasing the risk of intracranial hemorrhage or systematic bleeding. Another randomized trial found that treatment with intravenous tirofiban administration was safe and significantly improved 3-month functional outcomes in patients who experienced early neurological deterioration or no improvement within 24 hours of intravenous thrombolysis, compared with aspirin. Furthermore, our previous study found that early administration of tirofiban in patients with early neurological deterioration within the first 24 hours of intravenous thrombolysis did not increase the risk of symptomatic intracerebral hemorrhage, any intracerebral hemorrhage, or mortality. In contrast, it was associated with neurological improvement at 3 months. However, whether early administration of tirofiban can safely and effectively prevent neurological deterioration in patients with acute ischemic stroke treated with intravenous thrombolysis within 24 hours remains unclear, while the subset of patients who may benefit from early antiplatelet therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirofiban Group | Experimental | Drug: Tirofiban HydrochloridePatients will receive tirofiban in the first 24 hours after intravenous thrombolysis, then bridge to oral antiplatelet therapy. |
| Control group | Active comparator | Drug: Standard medical treatment (SMT)Aspirin, clopidogrel, or other antiplatelet drugs will be used in principle after 24 hours of thrombolytic therapy or until the primary outcome occurs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years old;
- Acute ischemic stroke treated with intravenous thrombolysis with alteplase or tenecteplase within 4.5 hours of onset or time last known well and can receive the study drug treatment within 3 hours of initiating intravenous thrombolysis.
- Residual NIHSS score ≥ 5 points at randomization (at least 1 hour after intravenous thrombolytic therapy).
- Post-thrombolysis imaging shows that the offending artery is consistent with moderate or severe intracranial atherosclerotic stenosis (within 50%~99%)
- Informed consent obtained from patients or their acceptable surrogates.
Key exclusion criteria (23 listed)
- Intracranial hemorrhage confirmed by imaging post-thrombolysis.
- Stroke caused by other determined causes, including moyamoya disease, artery dissection, arteritis, etc.
- Scheduled for or received endovascular treatment after onset.
- Definite or suspected cardioembolic stroke.
- Definite anticipation of developing indications for anticoagulant therapy during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid syndrome, hypercoagulable state).
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 until 24 hours after Intravenous thrombolytic therapy, or use a loading dose, 25 μg/kg, administrated within 3 minutes, then 0.15μg/kg/min infusion until 24 hours after Intravenous thrombolytic therapy. | Drug | Tirofiban Group |
| Standard medical treatment (SMT)Patients will receive standard antiplatelet therapy. | Drug | Control group |
Primary outcome
Proportion of patients experiencing neurological deterioration within 24 hours after intravenous thrombolysis.
Time frame: Within 24 hours after intravenous thombolysis.
National Health Institute Stroke Scale (NIHSS): stroke symptom severity scale ranging from 0-42. A higher score means more severe stroke symptoms. Neurological deterioration is defined as an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS.
17 secondary outcomes
Change of the NIHSS
Time frame: 7 days or discharge after intravenous thrombolytic therapy
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 30-day follow up.
Time frame: 30 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-1 at 90-day follow up.
Time frame: 90 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 30-day follow up.
Time frame: 30 days after stroke
The proportion of patients with a modified Rankin scale (mRS) score of 0-2 at 90-day follow up.
Time frame: 90 days after stroke
Distribution of modified Rankin Scale (mRS) scores at 90 day.
Time frame: 90 days after stroke
Incidence of symptomatic intracranial hemorrhage within 24 hours of intervention.
Time frame: Within 24 hours of intervention
Incidence of any intracranial hemorrhage within 24 hours of intervention.
Time frame: Within 24 hours of intervention
Incidence of systemic hemorrhage within 90 days after stroke.
Time frame: Within 90 days after stroke.
Incidence of recurrent stroke or other vascular events within 90 days after stroke.
Time frame: Within 90 days after stroke.
All-cause death within 90 days after stroke.
Time frame: Within 90 days after stroke.
Incidence of Adverse Events/Serious Adverse Events within 90 days after stroke.
Time frame: Within 90 days after stroke.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 2 points compared to the lowest NIHSS) within 24 hours after intravenous thrombolysis.
Time frame: Within 24 hours of intravenous thrombolysis.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 48 hours after intravenous thrombolysis.
Time frame: Within 48 hours after intravenous thrombolysis.
Proportion of patients experiencing (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 72 hours after intravenous thrombolysis.
Time frame: Within 72 hours after intravenous thrombolysis.
Proportion of patients experiencing neurological deterioration (an increase in NIHSS by ≥ 4 points compared to the lowest NIHSS) within 7 days after intravenous thrombolysis.
Time frame: Within 7 days after intravenous thrombolysis.
Proportion of patients with a decrease in NIHSS by ≥ 2 points compared to NIHSS at randomization.
Time frame: 24 hours after intravenous thrombolysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publication: 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.
- Results publication: PubMed 37256974Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.
- Results publication: 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.
- 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. This study is not recruiting at the moment.
1 site 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 Standard medical treatment (SMT) in people with Acute Stroke and Ischemic Stroke, Acute, run by Capital Medical 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 5 inclusion and 23 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 29 Oct 2024. 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. 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 XunMing Ji, MD, PD (86-10-8319-9439, jixm@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients experiencing neurological deterioration within 24 hours after intravenous thrombolysis. (time frame: Within 24 hours after intravenous thombolysis.). 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 NCT06587347, which also lists 3 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 29 Oct 2024.