Acute Ischemic StrokePhase 2RESETNCT05188417
A Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Alteplase in Acute Ischemic Stroke
A Phase 2 study testing Tirofiban 0.05 MG/ML and 0.9% sodium chloride solution in people with Acute Ischemic Stroke, run by GrandPharma (China) Co., Ltd. at 1 site in China.
Trial summary
The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with alteplase in acute ischemic stroke 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 0.05 MG/ML and 0.9% sodium chloride solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 9 Dec 2021to 30 Jun 2023
- Phase
- Phase 2
- 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
- According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
- ≥ 18 years of age, regardless of gender;
- Patients who have received or are scheduled to receive intravenous thrombolysis with alteplase, that is, receiving thrombolysis with alteplase within 4.5 hours of onset of ischemic stroke;
- Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;
- NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;
- Be able to engage in daily life independently before the onset of this ischemic stroke (mRS score: 0-1 point);
- The subject or his/her guardian participates voluntarily and signs the ICF.
Who cannot join
- Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);
- CT suggests large-area anterior circulation infarction (ASPECT score is < 6 points or infarction volume is ≥ 70 mL or infarction area is > 1/3 of the middle cerebral artery blood supply area);
- Significant head trauma or stroke within 3 months prior to screening;
- Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);
- Previous intracranial tumor, arteriovenous malformation or aneurysm;
- Intracranial or spinal surgery and biopsy within 3 months prior to screening;
Show all 26Show fewer
- Prolonged or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the past 10 days or recent puncture of a non-compression vessel (e.g., subclavian vein or jugular vein);
- Presence of active internal hemorrhage (e.g., gastrointestinal, urinary tract or retinal hemorrhage, etc.);
- Hemorrhagic tendency (including but not limited to): platelet count < 100 × 109/L during screening; heparin treatment within the last 48 hours and APTT exceeding the upper limit of laboratory normal value; oral administration of warfarin at the time of screening, INR > 1.7; oral administration of new anticoagulants; and using direct thrombin or factor Xa inhibitors;
- Hypertension is not controlled after active antihypertensive therapy: systolic blood pressure is ≥ 180 mmHg or diastolic blood pressure is ≥ 100 mmHg;
- Blood glucose concentration is < 50 mg/dL (2.8 mmol/L) or > 400 mg/dL (22.2 mmol/L);
- Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
- Serious renal insufficiency (creatinine clearance rate is < 30 mL/min);
- Currently undergoing renal dialysis;
- Aortic dissection;
- Major surgery or serious trauma within 30 days prior to screening;
- Gastrointestinal or urethral hemorrhage within 30 days prior to screening;
- History of acute myocardial infarction within 3 months prior to screening;
- It is known at the time of screening that subjects plan to undergo coronary, carotid or peripheral arterial revascularization during the trial;
- Female subjects who are serum pregnancy test positive, pregnant/lactating women, or women of childbearing potential who plan to have a pregnancy during the 12-month period, or women of childbearing potential or male subjects who are unwilling to take appropriate contraceptive measures during the trial;
- Users who are known to be allergic or contraindicated to the investigational product;
- Life expectancy of < 6 months due to any advanced disease;
- Patients who have participated in drug or device trials within one month;
- Patients with poor peripheral venous filling who cannot establish two standard peripheral venous lines;
- Stroke accompanied by seizures;
- Other conditions that the investigator considers inappropriate for participation in the clinical study, such as inability to understand and/or follow the study procedures and/or follow-up due to mental disorders, cognitive or emotional disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
23rd Floor, City Square, No.160 Qiaokou Road, Qiaokou District
Wuhan, Hubei, 430032
About this study
Official title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Intravenous Thrombolytic Therapy With Alteplase in Acute Ischemic Stroke
The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with alteplase in acute ischemic stroke
Read the detailed description
Ischemic stroke is a common disease of nervous system, with high morbidity, mortality and disability, which seriously threatens human health. According to the latest global burden of disease research, the overall lifetime risk of stroke in China is 39.9%, ranking first in the world, which means that about two out of every five people will suffer a stroke in their lifetime. In addition, stroke is also the first cause of life lost due to disease in China. Intravenous thrombolysis is one of the most effective treatment methods for AIS at present, and the commonly used thrombolytic drug is recombinant tissue plasminogen activator (rt-PA). Although the recanalization rate of intravenous thrombolysis with alteplase can reach about 50%, in actual treatment, about 1/3 of patients experience reocclusion after thrombolytic therapy, resulting in neurological deterioration.
Tirofiban is a highly effective and reversible non-peptide platelet surface glycoprotein (GP) IIb/IIIa receptor antagonist, which can competitively inhibit the binding of fibrinogen and platelet GP IIb/IIIa receptor, inhibit platelet aggregation, prolong bleeding time, and inhibit thrombosis. Tirofiban can inhibit platelet aggregation within 5 min after intravenous injection, with the time to peak of < 30 min, and achieve stable plasma concentration within 1 hour. Due to the short half-life (1.4-1.8 h), continuous administration is required, and platelet aggregation is restored in approximately 50% of patients 4 h after discontinuation. Therefore, tirofiban has the characteristics of rapid antiplatelet aggregation and rapid recovery of platelet function after discontinuation, and does not significantly increase the risk of bleeding events while preventing thrombosis.
For AIS patients whose onset time is within the thrombolytic time window, the results of preliminary research showed that tirofiban hydrochloride injection combined with intravenous thrombolytic therapy can reduce the volume of intracranial lesions in patients, better improve the symptoms of neurological deficits in patients than intravenous thrombolytic therapy alone, and the long-term neurological outcomes of patients with combined therapy are better than those with intravenous thrombolytic therapy alone. Observation of the efficacy of tirofiban at different time points after intravenous thrombolysis with alteplase in AIS showed that tirofiban 2-12 hours after intravenous thrombolysis had the greatest benefit in improving neural function.
With the accumulation of clinical experience in the treatment of ischemic cerebrovascular diseases and the development and popularization of interventional therapy, some shortcomings of oral antiplatelet drugs in the treatment of reocclusion have been found, such as insufficient antithrombotic strength, slow onset time, differences in patients' individuality, poor patient compliance and other problems. In addition, due to safety considerations, current guidelines at home and abroad do not recommend the administration of antiplatelet therapy within 24 hours after intravenous thrombolysis, which limits the therapeutic effect of AIS to some extent. Based on the pathophysiological mechanism of reocclusion and referring to the application experience of tirofiban in the cardiovascular field, many experts at home and abroad have carried out a series of clinical researches on the early application of tirofiban after intravenous thrombolytic and/or endovascular therapy to improve the recanalization rate and reduce reocclusion, showing good safety and efficacy, which has been affirmed by a number of diagnosis and treatment guidelines. However, although a large number of clinical experience and various clinical researches have proved the safety and efficacy of tirofiban's antiplatelet effect in different AIS treatments, there has been no large-sample randomized controlled clinical trial to verify its clinical efficacy in AIS.
This is a Phase 2 clinical study, and the subjects are patients with acute ischemic stroke who have received intravenous thrombolysis with alteplase within 4.5 hours of onset. The study is to evaluate the safety and efficacy of different doses of tirofiban hydrochloride sodium chloride injection compared with placebo in patients with acute ischemic stroke after intravenous thrombolytic therapy with alteplase.
Subjects who meet the inclusion criteria but do not meet the exclusion criteria are randomly divided into three groups: two groups with different doses of tirofiban hydrochloride sodium chloride injection and one placebo-controlled group, respectively, namely: Group 1 (tirofiban hydrochloride sodium chloride injection group at 0.25 μg/kg/min (0.005 ml/kg/min)); Group 2 (tirofiban hydrochloride sodium chloride injection group at 0.4 μg/kg/min (0.008 ml/kg/min)); and Group 3 (placebo 0.9% sodium chloride injection).
It should be ensured that subjects are given tirofiban or placebo within 12 hours after the end of thrombolysis. The patients are observed immediately after the end of administration, 4 hours after the end of administration, 48 hours, 7 days, and 14 days after the start of administration, and followed up to 90 days after the start of administration. The study endpoints include: the incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration (primary safety index), the incidence of intracranial hemorrhage within 48 hours after the start of administration (secondary safety index), etc., the proportion of subjects with mRS 0-1 score on the modified Rankin scale 90 days after the start of administration (primary efficacy index), and the value of change in NIHSS score from baseline at 48 hours, 7 and 14 days after the start of administration (secondary efficacy index), etc. The safety and efficacy of different doses of tirofiban hydrochloride sodium chloride injection compared with placebo in patients with acute ischemic stroke after intravenous thrombolytic therapy with alteplase are evaluated by statistical analysis of endpoint indexes.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Tirofiban 0.05 MG/ML, 0.9% sodium chloride solution
- Keywords
- Acute Ischemic Stroke, 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.
Tirofiban 0.05 MG/MLDrug
Also called Alteplase
intravenous injection of the drug according to different body weights and arms
0.9% sodium chloride solutionDrug
Also called Alteplase
intravenous injection of the drug according to different body weights and arms
| Study group | Role | What they receive |
|---|---|---|
| Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group | Experimental | The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.25μg/kg/min (0.005 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours. Receives: Drug: Tirofiban 0.05 MG/ML |
| Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group | Experimental | The tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.4 μg/kg/min (0.008 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours. Receives: Drug: Tirofiban 0.05 MG/ML |
| 0.9% sodium chloride solution | Placebo comparator | The placebo is pumped intravenously at a constant rate of 0.008 ml/kg/min for 30 minutes, and then pumped intravenously at a constant rate of 0.002 ml/kg/min for 24 hours. Receives: Drug: 0.9% sodium chloride solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration
Measured: 48 hours after the start of administration
Secondary outcomes (14)
The incidence of intracranial hemorrhage (Heidelberg bleeding classification) within 48 hours after the start of administration
Measured: 48 hours after the start of administration
The incidence of serious bleeding events (GUSTO defined, including fatal and symptomatic intracranial hemorrhage)within 48 hours after the start of administration
Measured: 48 hours after the start of administration
The incidence of parenchymal hemorrhage type 2 (PH-2) within 48 hours after the start of administration
Measured: 48 hours after the start of administration
The incidence of moderate bleeding (GUSTO defined) within 48 hours after the start of administration
Measured: 48 hours after the start of administration
The number of adverse events/serious adverse events reported by the investigator throughout the study period (e.g., absolute value of platelet ≤ 90 × 109/L; hypersensitivity; renal failure, etc.)
Measured: 90 days after the start of administration
All-cause mortality 90 days after the start of administration
Measured: 90 days after the start of administration
The proportion of subjects with mRS 0-1 score on the modified Rankin scale 90 days after the start of administration
Measured: 90 days after the start of administration
The value of change in National Institutes of Health Stroke Scale (NIHSS) score (0-42, higher scores mean a worse outcome) from baseline at 48 hours, 7 and 14 days after the start of administration
Measured: 48 hours, 7 and 14 days after the start of administration
Proportion of subjects whose NIHSS scores decrease by ≥ 2 points from baseline or recover to 0-1 point at 48 hours,7 and 14 days after the start of administration
Measured: 48 hours, 7 and 14 days after the start of administration
The incidence of worsening stroke (NIHSS score increases by ≥ 4 points, and the cause by cerebral hemorrhage is excluded) within 48 hours after the start of administration
Measured: 48 hours after the start of administration
Barthel Index (BI) score (0-100, higher scores mean a better outcome) 90 days after the start of administration
Measured: 90 days after the start of administration
The incidence of new vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, and cardio-cerebral revascularization) within 90 days after the start of administration
Measured: 90 days after the start of administration
EuroQol Five Dimensions Questionnaire (EQ-5D) (0-100, higher scores mean a better outcome) 90 days after the start of administration
Measured: 90 days after the start of administration
Platelet aggregation rate 30 minutes after the start of administration, immediately after the end of administration (i.e.,24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)
Measured: 30 minutes after the start of administration, immediately after the end of administration (i.e., 24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start9 Dec 2021
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- GrandPharma (China) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhipeng Wang, Ph.D, MD, Study director, GrandPharma (China) Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188417
- Sponsor's protocol ID
- GPTF0201
- Acronym
- RESET
- Status last verified
- Feb 2023
- First submitted
- 2 Dec 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of Tirofiban in Combination With Intravenous Thrombolytic Therapy With Alteplase in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT05188417
- Acronym / sponsor ID
- RESET / GPTF0201
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Tirofiban
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (actual)
- Lead sponsor
- GrandPharma (China) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 Jan 2022 (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 study is a prospective, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tirofiban in combination with intravenous thrombolytic therapy with alteplase in acute ischemic stroke
Detailed description
Ischemic stroke is a common disease of nervous system, with high morbidity, mortality and disability, which seriously threatens human health. According to the latest global burden of disease research, the overall lifetime risk of stroke in China is 39.9%, ranking first in the world, which means that about two out of every five people will suffer a stroke in their lifetime. In addition, stroke is also the first cause of life lost due to disease in China. Intravenous thrombolysis is one of the most effective treatment methods for AIS at present, and the commonly used thrombolytic drug is recombinant tissue plasminogen activator (rt-PA). Although the recanalization rate of intravenous thrombolysis with alteplase can reach about 50%, in actual treatment, about 1/3 of patients experience reocclusion after thrombolytic therapy, resulting in neurological deterioration.
Tirofiban is a highly effective and reversible non-peptide platelet surface glycoprotein (GP) IIb/IIIa receptor antagonist, which can competitively inhibit the binding of fibrinogen and platelet GP IIb/IIIa receptor, inhibit platelet aggregation, prolong bleeding time, and inhibit thrombosis. Tirofiban can inhibit platelet aggregation within 5 min after intravenous injection, with the time to peak of < 30 min, and achieve stable plasma concentration within 1 hour. Due to the short half-life (1.4-1.8 h), continuous administration is required, and platelet aggregation is restored in approximately 50% of patients 4 h after discontinuation. Therefore, tirofiban has the characteristics of rapid antiplatelet aggregation and rapid recovery of platelet function after discontinuation, and does not significantly increase the risk of bleeding events while preventing thrombosis.
For AIS patients whose onset time is within the thrombolytic time window, the results of preliminary research showed that tirofiban hydrochloride injection combined with intravenous thrombolytic therapy can reduce the volume of intracranial lesions in patients, better improve the symptoms of neurological deficits in patients than intravenous thrombolytic therapy alone, and the long-term neurological outcomes of patients with combined therapy are better than those with intravenous thrombolytic therapy alone. Observation of the efficacy of tirofiban at different time points after intravenous thrombolysis with alteplase in AIS showed that tirofiban 2-12 hours after intravenous thrombolysis had the greatest benefit in improving neural function.
With the accumulation of clinical experience in the treatment of ischemic cerebrovascular diseases and the development and popularization of interventional therapy, some shortcomings of oral antiplatelet drugs in the treatment of reocclusion have been found, such as insufficient antithrombotic strength, slow onset time, differences in patients' individuality, poor patient compliance and other problems. In addition, due to safety considerations, current guidelines at home and abroad do not recommend the administration of antiplatelet therapy within 24 hours after intravenous thrombolysis, which limits the therapeutic effect of AIS to some extent. Based on the pathophysiological mechanism of reocclusion and referring to the application experience of tirofiban in the cardiovascular field, many experts at home and abroad have carried out a series of clinical researches on the early application of tirofiban after intravenous thrombolytic and/or endovascular therapy to improve the recanalization rate and reduce reocclusion, showing good safety and efficacy, which has been affirmed by a number of diagnosis and treatment guidelines. However, although a large number of clinical experience and various clinical researches have proved the safety and efficacy of tirofiban's antiplatelet effect in different AIS treatments, there has been no large-sample randomized controlled clinical trial to verify its clinical efficacy in AIS.
This is a Phase 2 clinical study, and the subjects are patients with acute ischemic stroke who have received intravenous thrombolysis with alteplase within 4.5 hours of onset. The study is to evaluate the safety and efficacy of different doses of tirofiban hydrochloride sodium chloride injection compared with placebo in patients with acute ischemic stroke after intravenous thrombolytic therapy with alteplase.
Subjects who meet the inclusion criteria but do not meet the exclusion criteria are randomly divided into three groups: two groups with different doses of tirofiban hydrochloride sodium chloride injection and one placebo-controlled group, respectively, namely: Group 1 (tirofiban hydrochloride sodium chloride injection group at 0.25 μg/kg/min (0.005 ml/kg/min)); Group 2 (tirofiban hydrochloride sodium chloride injection group at 0.4 μg/kg/min (0.008 ml/kg/min)); and Group 3 (placebo 0.9% sodium chloride injection).
It should be ensured that subjects are given tirofiban or placebo within 12 hours after the end of thrombolysis. The patients are observed immediately after the end of administration, 4 hours after the end of administration, 48 hours, 7 days, and 14 days after the start of administration, and followed up to 90 days after the start of administration. The study endpoints include: the incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration (primary safety index), the incidence of intracranial hemorrhage within 48 hours after the start of administration (secondary safety index), etc., the proportion of subjects with mRS 0-1 score on the modified Rankin scale 90 days after the start of administration (primary efficacy index), and the value of change in NIHSS score from baseline at 48 hours, 7 and 14 days after the start of administration (secondary efficacy index), etc. The safety and efficacy of different doses of tirofiban hydrochloride sodium chloride injection compared with placebo in patients with acute ischemic stroke after intravenous thrombolytic therapy with alteplase are evaluated by statistical analysis of endpoint indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group | Experimental | Drug: Tirofiban 0.05 MG/MLThe tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.25μg/kg/min (0.005 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours. |
| Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group | Experimental | Drug: Tirofiban 0.05 MG/MLThe tirofiban hydrochloride sodium chloride injection is pumped intravenously at a constant rate of 0.4 μg/kg/min (0.008 ml/kg/min) for 30 minutes, and then pumped intravenously at a constant rate of 0.1 μg/kg/min (0.002 ml/kg/min) for 24 hours. |
| 0.9% sodium chloride solution | Placebo comparator | Drug: 0.9% sodium chloride solutionThe placebo is pumped intravenously at a constant rate of 0.008 ml/kg/min for 30 minutes, and then pumped intravenously at a constant rate of 0.002 ml/kg/min for 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- According to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018, the patient is clinically diagnosed as acute ischemic stroke;
- ≥ 18 years of age, regardless of gender;
- Patients who have received or are scheduled to receive intravenous thrombolysis with alteplase, that is, receiving thrombolysis with alteplase within 4.5 hours of onset of ischemic stroke;
- Intravenous antiplatelet therapy is acceptable within 12 hours of receiving intravenous thrombolysis;
- NIHSS score: 4 ≤ screening period/baseline NIHSS score ≤ 25;
Key exclusion criteria (26 listed)
- Combined with atrial fibrillation or clear evidence of cardiogenic embolism (e.g., known left atrial/left ventricular mural thrombosis, etc.);
- CT suggests large-area anterior circulation infarction (ASPECT score is < 6 points or infarction volume is ≥ 70 mL or infarction area is > 1/3 of the middle cerebral artery blood supply area);
- Significant head trauma or stroke within 3 months prior to screening;
- Previous history of intracranial hemorrhage (e.g., subarachnoid hemorrhage, and intracerebral hemorrhage);
- Previous intracranial tumor, arteriovenous malformation or aneurysm;
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 0.05 MG/MLAlso: Alteplaseintravenous injection of the drug according to different body weights and arms | Drug | Tirofiban 0.25μg/kg/min(0.005ml/kg/min) group, Tirofiban 0.4μg/kg/min(0.008ml/kg/min) group |
| 0.9% sodium chloride solutionAlso: Alteplaseintravenous injection of the drug according to different body weights and arms | Drug | 0.9% sodium chloride solution |
Primary outcome
The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
14 secondary outcomes
The incidence of intracranial hemorrhage (Heidelberg bleeding classification) within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
The incidence of serious bleeding events (GUSTO defined, including fatal and symptomatic intracranial hemorrhage)within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
The incidence of parenchymal hemorrhage type 2 (PH-2) within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
The incidence of moderate bleeding (GUSTO defined) within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
The number of adverse events/serious adverse events reported by the investigator throughout the study period (e.g., absolute value of platelet ≤ 90 × 109/L; hypersensitivity; renal failure, etc.)
Time frame: 90 days after the start of administration
All-cause mortality 90 days after the start of administration
Time frame: 90 days after the start of administration
The proportion of subjects with mRS 0-1 score on the modified Rankin scale 90 days after the start of administration
Time frame: 90 days after the start of administration
The value of change in National Institutes of Health Stroke Scale (NIHSS) score (0-42, higher scores mean a worse outcome) from baseline at 48 hours, 7 and 14 days after the start of administration
Time frame: 48 hours, 7 and 14 days after the start of administration
Proportion of subjects whose NIHSS scores decrease by ≥ 2 points from baseline or recover to 0-1 point at 48 hours,7 and 14 days after the start of administration
Time frame: 48 hours, 7 and 14 days after the start of administration
The incidence of worsening stroke (NIHSS score increases by ≥ 4 points, and the cause by cerebral hemorrhage is excluded) within 48 hours after the start of administration
Time frame: 48 hours after the start of administration
Barthel Index (BI) score (0-100, higher scores mean a better outcome) 90 days after the start of administration
Time frame: 90 days after the start of administration
The incidence of new vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, and cardio-cerebral revascularization) within 90 days after the start of administration
Time frame: 90 days after the start of administration
EuroQol Five Dimensions Questionnaire (EQ-5D) (0-100, higher scores mean a better outcome) 90 days after the start of administration
Time frame: 90 days after the start of administration
Platelet aggregation rate 30 minutes after the start of administration, immediately after the end of administration (i.e.,24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)
Time frame: 30 minutes after the start of administration, immediately after the end of administration (i.e., 24.5 hours), and 4 hours after the end of administration (i.e., 28.5 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Zhipeng Wang, Ph.D, MD study director
GrandPharma (China) Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tirofiban 0.05 MG/ML and 0.9% sodium chloride solution in people with Acute Ischemic Stroke, run by GrandPharma (China) Co., Ltd. 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 7 inclusion and 26 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 23 Feb 2023. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of symptomatic intracranial hemorrhage within 48 hours after the start of administration (time frame: 48 hours after the start of administration). 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 23 Feb 2023.