Brief Summary

The purpose of this study is to assess the safety and efficacy of early administration of tirofiban in patients treated with tenecteplase for acute ischemic stroke.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

348

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Apr 2024

Geographic Reach

1 country

38 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

October 28, 2022

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed

1.5 years until next milestone

Study Start

First participant enrolled

April 24, 2024

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed

Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

October 28, 2022

Last Update Submit

December 17, 2025

Conditions

Acute Ischemic Stroke

Keywords

randomized trialtenecteplasetirofibanintravenous thrombolysis

Outcome Measures

Primary Outcomes (1)

Excellent functional outcome
modified Rankin scale score of 0 to 1. modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death.
90 days post-randomization

Secondary Outcomes (10)

Ordinal degree of disability
90 days post-randomization
Functionally independent
90 days post-randomization
Ambulatory or bodily needs capable or better
90 days post-randomization
Early neurologic improvement
48 hours post-randomization
Health-related quality of life
90 days post-randomization
+5 more secondary outcomes

Other Outcomes (4)

Ordinal degree of disability
1 year post-randomization
Excellent functional status
1 year post-randomization
Functionally independent
1 year post-randomization
+1 more other outcomes

Study Arms (2)

Tirofiban

EXPERIMENTAL

Patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the tirofiban group will be treated with intravenous tirofiban. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Tirofiban will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.

Drug: Tirofiban Hydrochloride

Placebo

PLACEBO COMPARATOR

All patients are treated with intravenous tenecteplase first, and patients who meet the selection criteria will be randomly assigned to either the tirofiban or placebo group in a 1:1 ratio. Patients assigned to the placebo group will be treated with intravenous saline. It is recommended to start treatment as soon as possible (within 10 minutes recommended) after randomization. Placebo will be administered at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.

Drug: Placebo

Interventions

Tirofiban HydrochlorideDRUG

Patients will receive a continuous intravenous infusion of tirofiban at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin placebo (1 tablet) and/or clopidogrel placebo (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.

Tirofiban

PlaceboDRUG

Patients will receive a continuous intravenous infusion of placebo at a dose of 0.3 μg per kilogram of body weight per minute for 30 minutes, followed by a continuous infusion of 0.075 μg per kilogram per minute for 47.5h after start of tenecteplase treatment within 4-24 hours. Aspirin (1 tablet) and/or clopidogrel (1 tablet) will be given orally at 24h after intravenous tenecteplase. Antiplatelet therapy with aspirin (100 mg) and/or clopidogrel (75 mg) will be administered at 44h after randomization until the follow-up period of 90 days.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years old;
Within 4-24 hours after intravenous thrombolytic therapy with tenerplase for acute ischemic stroke, there was no significant change in symptoms compared to the baseline (defined as an increase or decrease of 0 or 1 point in the NIHSS score), and neurological function deteriorated (defined as an increase of ≥ 2 in the NIHSS score compared to the baseline) Fluctuations in neurological function (defined as an increase of 4 points or more in the NIHSS score compared to the baseline and then a decrease of 4 points or more);
NIHSS ≥ 4 points before randomization;
The patient or their family members sign a written informed consent form.

You may not qualify if:

Intracranial hemorrhage was confirmed by CT or MRI after intravenous thrombolysis and before randomization;
CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1, M2 or M3 segment, anterior cerebral artery A1, A2 or A3 segment, posterior cerebral artery P1, P2 or P3, vertebral or basilar artery;
Confirmed or suspected cardioembolic stroke mechanisms, including any of the following: documented cardiac sources of thromboembolism: chronic or paroxysmal atrial fibrillation, rheumatic mitral stenosis, prosthetic heart valves, infective endocarditis, intracardiac thrombus or implanted prosthetic material, dilated cardiomyopathy (left ventricular ejection fraction \<40%), or spontaneous echo contrast in the left atrium; other laboratory-confirmed embolic sources: patent foramen ovale with concomitant atrial septal aneurysm, or cryptogenic stroke with a CHADS-VASC score ≥ 2 indicating high thromboembolic risk;
Blood platelet count was lower than 100×10\^9/L;
Renal insufficiency, glomerular filtration rate \< 30 mL/min;
Pregnant or lactating women;
Allergic to tirofiban, nickel, titanium or their alloys;
Prior neurological or psychiatric illness that prevents assessment of neurological function;
Pre-existing bleeding disease, severe heart, liver, or kidney disease, or sepsis;
Brain tumors with a space-occupying effect on imaging (other than micromeningiomas);
Intracranial aneurysm, arteriovenous malformation;
Life expectancy of any advanced disease \< 6 months;
Participating in other clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Second Affiliated Hospital of Guangxi Medical Universitylead
Ganzhou City People's Hospitalcollaborator

Study Sites (38)

Mingguang People's Hospital

Chuzhou, Anhui, China

RECRUITING

Longyan People´s Hospital, Longyan City

Longyan, Fujian, China

RECRUITING

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

Huangmei People's Hospital

Huanggang, Hubei, China

RECRUITING

Yiling People's Hospital of Yichang city

Yichang, Hubei, China

RECRUITING

Hunan Xupu Chengnan Hospital

Huaihua, Hunan, China

RECRUITING

People's Hospital Of Shaodong

Shaoyang, Hunan, China

RECRUITING

Shaoshan People's Hospital

Xiangtan, Hunan, China

RECRUITING

Xiangtan Central Hospitall

Xiangtan, Hunan, China

RECRUITING

Hunan University of Medicine Affiliated Pingjiang Hospital

Yueyang, Hunan, China

RECRUITING

Ganzhou People's Hospital