NCT04491695

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
420

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

19 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2.3 years

First QC Date

July 25, 2020

Last Update Submit

July 16, 2022

Conditions

Acute Stroke

Keywords

Acute ischemic strokeNeurological deteriorationStroke progression

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 72 hours of intervention.

Secondary Outcomes (5)

  • Change of the NIHSS

    0-30 days of intervention.

  • Change of the Scandinavian Stroke Scale

    0-30 days of intervention.

  • The severity of global disability at 90 days, as assessed by modified Rankin scale (mRS).

    0-90 days.

  • Rate of symptomatic intracerebral hemorrhage.

    0-90 days

  • Number of Participants experienced adverse events

    0-90 days.

Study Arms (2)

Tirofiban+Oral antiplatelet therapy

EXPERIMENTAL

Patients will receive Tirofiban in the first 72 hours and bridge to oral antiplatelet therapy thereafter.

Drug: Tirofiban HydrochlorideDrug: Oral antiplatelet

Oral antiplatelet therapy

ACTIVE COMPARATOR

Patients will receive oral antiplatelet therapy alone.

Drug: Oral antiplatelet

Interventions

Tirofiban HydrochlorideDRUG

Tirofiban will use a loading dose, 0.4 μg/kg/min Ă— 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.

Tirofiban+Oral antiplatelet therapy
Oral antiplateletDRUG

Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.

Oral antiplatelet therapyTirofiban+Oral antiplatelet therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

The first Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

NOT YET RECRUITING

Nanyang Central Hospital

Nanyang, Henan, China

RECRUITING

Nanyang Second General Hospital

Nanyang, Henan, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

NOT YET RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT YET RECRUITING

The Third People's Hospital of Hubei Province

Wuhan, Hubei, China

ACTIVE NOT RECRUITING

Hunan Provincial People's Hospital

Changsha, Hunan, China

NOT YET RECRUITING

Sinapharm North Hospital

Baotou, Inner Mongolia, China

RECRUITING

Ordos Central Hospital

Ordos, Inner Mongolia, China

RECRUITING

Tongliao City Hosptial

Tongliao, Inner Mongolia, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

ACTIVE NOT RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

ACTIVE NOT RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

NOT YET RECRUITING

Beichen Hospital of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

RECRUITING

TEDA Hospital

Tianjin, Tianjin Municipality, China

ACTIVE NOT RECRUITING

Related Publications (5)

  • 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.

    PMID: 31570084BACKGROUND

  • Zhao 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.

    PMID: 29127270RESULT

  • Wang 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.

    PMID: 39950764DERIVED

  • Wang 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.

    PMID: 39036300DERIVED

  • 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.

    PMID: 38648030DERIVED

MeSH Terms

Conditions

StrokeIschemic Stroke

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Qingfeng Ma, M.D.

CONTACT

010-83199430m.qingfeng@163.com

Wenbo Zhao, M.D.

CONTACT

86-13120136877zhaowb.cool@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 25, 2020

First Posted

July 29, 2020

Study Start

September 12, 2020

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

CN(19)