search
Back to results

Efficacy and Safety of Tirofiban for Patients With BAD (BRANT) (BRANT)

Primary Purpose

Branch Atheromatous Disease

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tirofiban
Aspirin tablet
Clopidogrel tablet
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Branch Atheromatous Disease focused on measuring Branch atheromatous disease, Tirofiban, Stroke, Treatment Outcome, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18-75 years old Acute ischemic stroke Time from onset to randomization ≤48h; if onset time is unknown, time from last known well to randomization ≤48h Meet the following BAD Diagnostic Imaging Criteria 4.1. DWI infarcts: single (isolated) deep (subcortical) infarcts; 4.2. The culprit arteries are either Lenticulostriate artery (LSA) or Paramedian pontine artery (PPA), and the infarct lesion on DWI conforms to one of the following characteristics (A/B): A. LSA: 1) "Comma-like" infarct lesions with "Fan-shaped" extension from bottom to top in the coronary position; or 2) ≥ 3 layers (layer thickness 5-7 mm) on axial DWI brain images; B. PPA: The infarct lesion extends from the deep pons to the ventral pons on the axial DWI brain images; 4.3. No more than 50% stenosis on the parent artery of the criminal artery (i.e. corresponding basilar or middle cerebral artery) (Confirmed by magnetic resonance angiography [MRA] or computed tomography angiography [CTA] or digital substraction angiography [DSA]). Singed informed consent by the patient or legally authorized representatives. Exclusion Criteria: Transient ischemic attack (TIA) Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space-occupying lesions, or other non-ischemic intracranial lesions detected by baseline CT/MRI, or MRA/CTA/DSA; Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion; Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute Have received or plan to receive endovascular therapy or thrombolysis after onset; Stroke of other clear causes, e.g., moyamoya disease, arterial entrapment, vasculitis, etc. modified Rankin Scale ≥2 before onset Use of tirofiban within 1 week before or after onset Low platelets (<100×10^9 /L), or Prothrombin time >1.3 times of the upper normal limit, or INR >1.5, or other systemic hemorrhagic tendencies such as hematologic disorders Elevation of ALT or AST more than 1.5 times the upper normal limit; Glomerular filtration rate <60 ml/min/1.73m^2 Known malignant tumors History of trauma or major surgical intervention within 6 weeks prior to onset History of intracranial hemorrhage Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding) Malignant hypertension (systolic blood pressure >200 mmHg, or diastolic blood pressure >120 mmHg) Life expectancy ≤ 6 months Contraindications of 3 T MRI examination Pregnant or lactating women Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.

Sites / Locations

  • Jun Ni

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tirofiban group

Standard antiplatelet therapy group

Arm Description

Intravenous tirofiban will be administered immediately after randomization for a total duration of 48h with a loading dose of 0.4ug/kg/min*30min, followed by a maintenance dose of 0.1ug/kg/min*47.5h.

Standard antiplatelet therapy based on Chinese stroke guideline will be administered after randomization for a total duration of 48h, as the two following types: 1) aspirin 150-300 mg qd, or 2) aspirin 100 mg qd plus clopidogrel 75 mg qd. The time for administration of antiplatelet drugs will be determined by the doctor in conjunction with the participants' use of antiplatelet or anticoagulant medication in the 24h prior to randomization, but the drug should be given as soon as possible after randomization.

Outcomes

Primary Outcome Measures

Excellent functional outcome
Primary efficacy outcome: Excellent functional outcome is defined as modified Rankin Scale score: 0-1. Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Death.
Proportion of major bleeding
Primary safety outcome: Participants with major bleeding defined by the PLATO criteria, confirmed by the Clinical Event Committee.

Secondary Outcome Measures

Excellent functional outcome
modified Rankin Scale score: 0-1
Early neurological deterioration
The presence of END is determined by an increase of ≥ 4 points in the NIHSS or an increase of ≥2 points in the NIHSS motor score. In addition, NIHSS motor score refers to bilateral upper and lower extremity mobility scores. The baseline NIHSS score for the calculation of END is the first clinician-evaluated and recorded NIHSS score after onset. The time frame for post-randomization END is within 7 days of randomization.
NIHSS score
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Barthel index score
The Barthel Index (BI) is tool to measure the extent to which somebody can function independently and has mobility in activities of daily living (ADL), including 10 aspects: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Higher score indicates better performance in activities of daily living.
Ischemic stroke
Number of participants with new-onset ischemic stroke, confirmed by senior neurologists and the Clinical Event Committee.
Stroke
Number of participants with new-onset ischemic or hemorrhagic stroke, confirmed by senior neurologists and the Clinical Event Committee.
TIA
Number of participants with new-onset transient ischemic attack (TIA), confirmed by senior neurologists and the Clinical Event Committee.
Composite endpoint
Number of participants with new-onset stroke, myocardial Infarction, or all-cause death, confirmed by the Clinical Event Committee.
Proportion of Major bleeding
Proportion of major bleeding defined by the PLATO criteria.
Serious adverse events
Serious adverse events
Adverse events
Adverse events
All-cause death
All-cause death
Changes in hemoglobin
Blood test of the count of hemoglobin, g/L
Changes in the count of red blood cell
Blood test of the count of red blood cell, 10^12/L
Changes in the count of white blood cell
Blood test of the count of white blood cell, 10^9/L
Changes in the count of platelets
Blood test of the count of platelets, 10^9/L
Changes in alanine transaminase
Serum biochemical test for alanine transaminase
Changes in aspartate aminotransferase
Serum biochemical test for aspartate aminotransferase
Changes in direct bilirubin
Serum biochemical test for the concentration of direct bilirubin
Changes in indirect bilirubin
Serum biochemical test for the concentration of indirect bilirubin
Changes in concentration of Na
Serum biochemical test for the concentration of sodium, mmol/L
Changes in the concentration of K
Serum biochemical test for the concentration of potassium, mmol/L
Changes in the concentration of creatinine
Serum biochemical test for creatinine
Changes in the concentration of albumin
Serum biochemical test for albumin
Changes in the urinary occult blood
The test of urine blood (BLD). Negative or positive.
Changes in the fecal occult blood
The test of occult blood (Occult blood, OB). Negative or positive

Full Information

First Posted
September 7, 2023
Last Updated
September 20, 2023
Sponsor
Peking Union Medical College Hospital
Collaborators
Pharmaron (Chengdu) Clinical Services Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT06037889
Brief Title
Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)
Acronym
BRANT
Official Title
Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Pharmaron (Chengdu) Clinical Services Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Branch atheromatous disease (BAD)-related stroke, characterized by subcortical single infarcts without severe stenosis of the large artery, but with a clear atherosclerotic mechanism, is now regarded as a separate stroke type. BAD is associated with early neurological deterioration and poor prognosis, but is lack of effective therapy. The goal of this randomized controlled trial is to test the efficacy and safety of intravenous tirofiban in patients with acute ischemic stroke caused by branch atheromatous disease. The main question it aims to answer is: Compared with standard antiplatelet therapy based on current stroke guideline, whether tirofiban used in acute phase of BAD could improve the proportion of excellent functional outcome (modified Rankin Scale: 0-1) at 90 days. Researcher will also compare the rate of major bleeding between treatment and control groups.
Detailed Description
BRANT study is a multicenter, randomized, open label, blinded endpoint, Parallel controlled trial with the primary null hypothesis that, in patients with acute BAD-related stroke, there is no difference in the proportion of excellent outcome in those treated with intravenous Tirofiban compared with those treated with standard antiplatelet therapy based on guideline when subjects are randomized within 48 hours of stroke onset. The primary objective is to determine whether intravenous tirofiban (a loading dose of 0.4ug/kg/min*30min followed by a maintenance dose of 0.1ug/kg/min*47.5h) is effective in increasing the proportion of excellent functional outcome (mR: 0-1) at 90 days, when initiated within 48 hours of onset. The active comparator is standard antiplatelet therapy based on guideline [ie, 1) aspirin 150-300 mg qd, OR 2) aspirin 100 mg qd plus clopidogrel 75 mg qd] for 48 hours. Patients with acute BAD-related stroke between 18 and 75 years old, who can be randomized within 48 hours of onset, and meet the BAD Diagnostic Imaging Criteria, will be enrolled. All patients will conduct MRI before randomization. Subjects will be randomized 1:1 (Tirofiban: Standard antiplatelet therapy). The subjects' eligibility will be assessed by site investigator prior to accessing the Randomization Module, which is generated via the dynamic block randomization method. Only certified and trained personnel can access the randomization website, who will get the information of treatment (ie, Tirofiban or standard antiplatelet therapy) after the subject has be determined eligible. The treatment period is 48 hours for both study groups. A total of 516 eligible patients will be enrolled. Each participant will be followed for 90 days from randomization. The primary outcome will be assessed by well-trained senior neurologists blinded to the treatment. All the clinical and safety events will be re-examined by the Clinical Event Committee (CEC), who are blinded during all procedures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Branch Atheromatous Disease
Keywords
Branch atheromatous disease, Tirofiban, Stroke, Treatment Outcome, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multi-center, randomized, open label, blinded endpoint, parallel controlled trial
Masking
Outcomes Assessor
Masking Description
Our study is an open label, blinded endpoint trail. The primary outcome should be measured in a blinded manner, and the qualified evaluator is defined as: 1) Attending neurologists or above; 2) Complete the training for mRS score before the initiation of patient enrollment; 3) Blind to the antiplatelet treatment of the participants; and 4) Sign the evaluation when it is completed, and inform the other investigators of the results. All the clinical and safety events will be re-examined by the independent Clinical Event Committee (CEC), who are blinded during all procedures.
Allocation
Randomized
Enrollment
516 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tirofiban group
Arm Type
Experimental
Arm Description
Intravenous tirofiban will be administered immediately after randomization for a total duration of 48h with a loading dose of 0.4ug/kg/min*30min, followed by a maintenance dose of 0.1ug/kg/min*47.5h.
Arm Title
Standard antiplatelet therapy group
Arm Type
Active Comparator
Arm Description
Standard antiplatelet therapy based on Chinese stroke guideline will be administered after randomization for a total duration of 48h, as the two following types: 1) aspirin 150-300 mg qd, or 2) aspirin 100 mg qd plus clopidogrel 75 mg qd. The time for administration of antiplatelet drugs will be determined by the doctor in conjunction with the participants' use of antiplatelet or anticoagulant medication in the 24h prior to randomization, but the drug should be given as soon as possible after randomization.
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Other Intervention Name(s)
Tirofiban Hydrochloride and Sodium Chloride Injection
Intervention Description
Tirofiban, a GPIIb/IIIa receptor inhibitor. Intravenous administration.
Intervention Type
Drug
Intervention Name(s)
Aspirin tablet
Intervention Description
Aspirin. Oral administration.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel tablet
Intervention Description
Clopidogrel. Oral administration.
Primary Outcome Measure Information:
Title
Excellent functional outcome
Description
Primary efficacy outcome: Excellent functional outcome is defined as modified Rankin Scale score: 0-1. Modified Rankin Scale, a commonly used scale for measuring the degree of dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. 0 - No symptoms.1 - No significant disability. Able to carry out all usual activities, despite some symptoms.2 - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.3 - Moderate disability. Requires some help, but able to walk unassisted.4 - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.5 - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6 - Death.
Time Frame
90 days
Title
Proportion of major bleeding
Description
Primary safety outcome: Participants with major bleeding defined by the PLATO criteria, confirmed by the Clinical Event Committee.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Excellent functional outcome
Description
modified Rankin Scale score: 0-1
Time Frame
7 days
Title
Early neurological deterioration
Description
The presence of END is determined by an increase of ≥ 4 points in the NIHSS or an increase of ≥2 points in the NIHSS motor score. In addition, NIHSS motor score refers to bilateral upper and lower extremity mobility scores. The baseline NIHSS score for the calculation of END is the first clinician-evaluated and recorded NIHSS score after onset. The time frame for post-randomization END is within 7 days of randomization.
Time Frame
7 days of randomization
Title
NIHSS score
Description
The NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time Frame
7 days and 90 days
Title
Barthel index score
Description
The Barthel Index (BI) is tool to measure the extent to which somebody can function independently and has mobility in activities of daily living (ADL), including 10 aspects: feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Higher score indicates better performance in activities of daily living.
Time Frame
7 days and 90 days
Title
Ischemic stroke
Description
Number of participants with new-onset ischemic stroke, confirmed by senior neurologists and the Clinical Event Committee.
Time Frame
7 days and 90 days
Title
Stroke
Description
Number of participants with new-onset ischemic or hemorrhagic stroke, confirmed by senior neurologists and the Clinical Event Committee.
Time Frame
7 days and 90 days
Title
TIA
Description
Number of participants with new-onset transient ischemic attack (TIA), confirmed by senior neurologists and the Clinical Event Committee.
Time Frame
7 days and 90 days
Title
Composite endpoint
Description
Number of participants with new-onset stroke, myocardial Infarction, or all-cause death, confirmed by the Clinical Event Committee.
Time Frame
7 days and 90 days
Title
Proportion of Major bleeding
Description
Proportion of major bleeding defined by the PLATO criteria.
Time Frame
7 days
Title
Serious adverse events
Description
Serious adverse events
Time Frame
7 and 90 days
Title
Adverse events
Description
Adverse events
Time Frame
7 and 90 days
Title
All-cause death
Description
All-cause death
Time Frame
7 and 90 days
Title
Changes in hemoglobin
Description
Blood test of the count of hemoglobin, g/L
Time Frame
48 hours
Title
Changes in the count of red blood cell
Description
Blood test of the count of red blood cell, 10^12/L
Time Frame
48 hours
Title
Changes in the count of white blood cell
Description
Blood test of the count of white blood cell, 10^9/L
Time Frame
48 hours
Title
Changes in the count of platelets
Description
Blood test of the count of platelets, 10^9/L
Time Frame
48 hours
Title
Changes in alanine transaminase
Description
Serum biochemical test for alanine transaminase
Time Frame
48 hours
Title
Changes in aspartate aminotransferase
Description
Serum biochemical test for aspartate aminotransferase
Time Frame
48 hours
Title
Changes in direct bilirubin
Description
Serum biochemical test for the concentration of direct bilirubin
Time Frame
48 hours
Title
Changes in indirect bilirubin
Description
Serum biochemical test for the concentration of indirect bilirubin
Time Frame
48 hours
Title
Changes in concentration of Na
Description
Serum biochemical test for the concentration of sodium, mmol/L
Time Frame
48 hours
Title
Changes in the concentration of K
Description
Serum biochemical test for the concentration of potassium, mmol/L
Time Frame
48 hours
Title
Changes in the concentration of creatinine
Description
Serum biochemical test for creatinine
Time Frame
48 hours
Title
Changes in the concentration of albumin
Description
Serum biochemical test for albumin
Time Frame
48 hours
Title
Changes in the urinary occult blood
Description
The test of urine blood (BLD). Negative or positive.
Time Frame
48 hours
Title
Changes in the fecal occult blood
Description
The test of occult blood (Occult blood, OB). Negative or positive
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-75 years old Acute ischemic stroke Time from onset to randomization ≤48h; if onset time is unknown, time from last known well to randomization ≤48h Meet the following BAD Diagnostic Imaging Criteria 4.1. DWI infarcts: single (isolated) deep (subcortical) infarcts; 4.2. The culprit arteries are either Lenticulostriate artery (LSA) or Paramedian pontine artery (PPA), and the infarct lesion on DWI conforms to one of the following characteristics (A/B): A. LSA: 1) "Comma-like" infarct lesions with "Fan-shaped" extension from bottom to top in the coronary position; or 2) ≥ 3 layers (layer thickness 5-7 mm) on axial DWI brain images; B. PPA: The infarct lesion extends from the deep pons to the ventral pons on the axial DWI brain images; 4.3. No more than 50% stenosis on the parent artery of the criminal artery (i.e. corresponding basilar or middle cerebral artery) (Confirmed by magnetic resonance angiography [MRA] or computed tomography angiography [CTA] or digital substraction angiography [DSA]). Singed informed consent by the patient or legally authorized representatives. Exclusion Criteria: Transient ischemic attack (TIA) Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space-occupying lesions, or other non-ischemic intracranial lesions detected by baseline CT/MRI, or MRA/CTA/DSA; Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion; Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute Have received or plan to receive endovascular therapy or thrombolysis after onset; Stroke of other clear causes, e.g., moyamoya disease, arterial entrapment, vasculitis, etc. modified Rankin Scale ≥2 before onset Use of tirofiban within 1 week before or after onset Low platelets (<100×10^9 /L), or Prothrombin time >1.3 times of the upper normal limit, or INR >1.5, or other systemic hemorrhagic tendencies such as hematologic disorders Elevation of ALT or AST more than 1.5 times the upper normal limit; Glomerular filtration rate <60 ml/min/1.73m^2 Known malignant tumors History of trauma or major surgical intervention within 6 weeks prior to onset History of intracranial hemorrhage Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding) Malignant hypertension (systolic blood pressure >200 mmHg, or diastolic blood pressure >120 mmHg) Life expectancy ≤ 6 months Contraindications of 3 T MRI examination Pregnant or lactating women Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengde Li, MD
Phone
86 17896002828
Email
lishengde.medicine@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuhui Sha
Phone
86 18810678122
Email
shayh2016@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Ni, MD
Organizational Affiliation
The office for BRANT study
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jun Ni
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26671513
Citation
Petrone L, Nannoni S, Del Bene A, Palumbo V, Inzitari D. Branch Atheromatous Disease: A Clinically Meaningful, Yet Unproven Concept. Cerebrovasc Dis. 2016;41(1-2):87-95. doi: 10.1159/000442577. Epub 2015 Dec 16.
Results Reference
background
PubMed Identifier
26833987
Citation
Bang OY. Considerations When Subtyping Ischemic Stroke in Asian Patients. J Clin Neurol. 2016 Apr;12(2):129-36. doi: 10.3988/jcn.2016.12.2.129. Epub 2016 Jan 28.
Results Reference
background
PubMed Identifier
25052317
Citation
Zhang C, Wang Y, Zhao X, Wang D, Liu L, Wang C, Pu Y, Zou X, Du W, Jing J, Pan Y, Wong KS, Wang Y; Chinese Intracranial Atherosclerosis Study Group. Distal single subcortical infarction had a better clinical outcome compared with proximal single subcortical infarction. Stroke. 2014 Sep;45(9):2613-9. doi: 10.1161/STROKEAHA.114.005634. Epub 2014 Jul 22.
Results Reference
background
PubMed Identifier
25677600
Citation
Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ. Neuroimaging markers for early neurologic deterioration in single small subcortical infarction. Stroke. 2015 Mar;46(3):687-91. doi: 10.1161/STROKEAHA.114.007466. Epub 2015 Feb 12.
Results Reference
background
PubMed Identifier
33427887
Citation
Seners P, Ben Hassen W, Lapergue B, Arquizan C, Heldner MR, Henon H, Perrin C, Strambo D, Cottier JP, Sablot D, Girard Buttaz I, Tamazyan R, Preterre C, Agius P, Laksiri N, Mechtouff L, Bejot Y, Duong DL, Mounier-Vehier F, Mione G, Rosso C, Lucas L, Papassin J, Aignatoaie A, Triquenot A, Carrera E, Niclot P, Obadia A, Lyoubi A, Garnier P, Crainic N, Wolff V, Tracol C, Philippeau F, Lamy C, Soize S, Baron JC, Turc G; MINOR-STROKE Collaborators. Prediction of Early Neurological Deterioration in Individuals With Minor Stroke and Large Vessel Occlusion Intended for Intravenous Thrombolysis Alone. JAMA Neurol. 2021 Mar 1;78(3):321-328. doi: 10.1001/jamaneurol.2020.4557.
Results Reference
background
PubMed Identifier
26032577
Citation
Duan Z, Fu C, Chen B, Xu G, Tao L, Tang T, Hou H, Fu X, Yang M, Liu Z, Zhang X. Lesion patterns of single small subcortical infarct and its association with early neurological deterioration. Neurol Sci. 2015 Oct;36(10):1851-7. doi: 10.1007/s10072-015-2267-1. Epub 2015 Jun 2.
Results Reference
background
PubMed Identifier
27351585
Citation
Helleberg BH, Ellekjaer H, Indredavik B. Outcomes after Early Neurological Deterioration and Transitory Deterioration in Acute Ischemic Stroke Patients. Cerebrovasc Dis. 2016;42(5-6):378-386. doi: 10.1159/000447130. Epub 2016 Jun 29.
Results Reference
background
PubMed Identifier
33317415
Citation
Heitsch L, Ibanez L, Carrera C, Binkley MM, Strbian D, Tatlisumak T, Bustamante A, Ribo M, Molina C, Davalos A, Lopez-Cancio E, Munoz-Narbona L, Soriano-Tarraga C, Giralt-Steinhauer E, Obach V, Slowik A, Pera J, Lapicka-Bodzioch K, Derbisz J, Sobrino T, Castillo J, Campos F, Rodriguez-Castro E, Arias-Rivas S, Segura T, Serrano-Heras G, Vives-Bauza C, Diaz-Navarro R, Tur S, Jimenez C, Marti-Fabregas J, Delgado-Mederos R, Arenillas J, Krupinski J, Cullell N, Torres-Aguila NP, Muino E, Carcel-Marquez J, Moniche F, Cabezas JA, Ford AL, Dhar R, Roquer J, Khatri P, Jimenez-Conde J, Fernandez-Cadenas I, Montaner J, Rosand J, Cruchaga C, Lee JM; International Stroke Genetics Consortium. Early Neurological Change After Ischemic Stroke Is Associated With 90-Day Outcome. Stroke. 2021 Jan;52(1):132-141. doi: 10.1161/STROKEAHA.119.028687. Epub 2020 Dec 15.
Results Reference
background
PubMed Identifier
27452127
Citation
Park MG, Oh EH, Kim BK, Park KP. Intravenous tissue plasminogen activator in acute branch atheromatous disease: Does it prevent early neurological deterioration? J Clin Neurosci. 2016 Nov;33:194-197. doi: 10.1016/j.jocn.2016.04.011. Epub 2016 Jul 21.
Results Reference
background
PubMed Identifier
24970907
Citation
Seners P, Turc G, Oppenheim C, Baron JC. Incidence, causes and predictors of neurological deterioration occurring within 24 h following acute ischaemic stroke: a systematic review with pathophysiological implications. J Neurol Neurosurg Psychiatry. 2015 Jan;86(1):87-94. doi: 10.1136/jnnp-2014-308327. Epub 2014 Jun 26.
Results Reference
background
PubMed Identifier
33070714
Citation
Ospel JM, Menon BK, Demchuk AM, Almekhlafi MA, Kashani N, Mayank A, Fainardi E, Rubiera M, Khaw A, Shankar JJ, Dowlatshahi D, Puig J, Sohn SI, Ahn SH, Poppe A, Calleja A, Hill MD, Goyal M. Clinical Course of Acute Ischemic Stroke Due to Medium Vessel Occlusion With and Without Intravenous Alteplase Treatment. Stroke. 2020 Nov;51(11):3232-3240. doi: 10.1161/STROKEAHA.120.030227. Epub 2020 Oct 19.
Results Reference
background
PubMed Identifier
32733357
Citation
Wu X, Liu Y, Nie C, Kang Z, Wang Q, Sun D, Li H, Liu Y, Mei B. Efficacy and Safety of Intravenous Thrombolysis on Acute Branch Atheromatous Disease: A Retrospective Case-Control Study. Front Neurol. 2020 Jul 7;11:581. doi: 10.3389/fneur.2020.00581. eCollection 2020.
Results Reference
background
PubMed Identifier
30128710
Citation
Yi X, Zhou Q, Wang C, Lin J, Chai Z. Aspirin plus clopidogrel may reduce the risk of early neurologic deterioration in ischemic stroke patients carrying CYP2C19*2 reduced-function alleles. J Neurol. 2018 Oct;265(10):2396-2403. doi: 10.1007/s00415-018-8998-1. Epub 2018 Aug 20.
Results Reference
background
PubMed Identifier
32345264
Citation
Yi X, Zhou Q, Zhang Y, Zhou J, Lin J. Variants in clopidogrel-relevant genes and early neurological deterioration in ischemic stroke patients receiving clopidogrel. BMC Neurol. 2020 Apr 28;20(1):159. doi: 10.1186/s12883-020-01703-6.
Results Reference
background
PubMed Identifier
22893265
Citation
Wang Q, Chen C, Chen XY, Han JH, Soo Y, Leung TW, Mok V, Wong KS. Low-molecular-weight heparin and early neurologic deterioration in acute stroke caused by large artery occlusive disease. Arch Neurol. 2012 Nov;69(11):1454-60. doi: 10.1001/archneurol.2012.1633.
Results Reference
background
PubMed Identifier
32933416
Citation
Yang J, Wu Y, Gao X, Bivard A, Levi CR, Parsons MW, Lin L; INSPIRE Study Groupdagger. Intraarterial Versus Intravenous Tirofiban as an Adjunct to Endovascular Thrombectomy for Acute Ischemic Stroke. Stroke. 2020 Oct;51(10):2925-2933. doi: 10.1161/STROKEAHA.120.029994. Epub 2020 Sep 16.
Results Reference
background
PubMed Identifier
31570084
Citation
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.
Results Reference
background
PubMed Identifier
32459110
Citation
Liu B, Zhang H, Wang R, Qu H, Sun Y, Zhang W, Zhang S. Early administration of tirofiban after urokinase-mediated intravenous thrombolysis reduces early neurological deterioration in patients with branch atheromatous disease. J Int Med Res. 2020 May;48(5):300060520926298. doi: 10.1177/0300060520926298.
Results Reference
background
PubMed Identifier
30793464
Citation
Pan X, Zheng D, Zheng Y, Chan PWL, Lin Y, Zou J, Zhou J, Yang J. Safety and efficacy of tirofiban combined with endovascular treatment in acute ischaemic stroke. Eur J Neurol. 2019 Aug;26(8):1105-1110. doi: 10.1111/ene.13946. Epub 2019 Mar 19.
Results Reference
background
PubMed Identifier
23060895
Citation
Chung JW, Kim BJ, Sohn CH, Yoon BW, Lee SH. Branch atheromatous plaque: a major cause of lacunar infarction (high-resolution MRI study). Cerebrovasc Dis Extra. 2012 Jan;2(1):36-44. doi: 10.1159/000341399. Epub 2012 Jul 27.
Results Reference
background
PubMed Identifier
29572675
Citation
Liang J, Liu Y, Xu X, Shi C, Luo L. Cerebral Perforating Artery Disease : Characteristics on High-Resolution Magnetic Resonance Imaging. Clin Neuroradiol. 2019 Sep;29(3):533-541. doi: 10.1007/s00062-018-0682-4. Epub 2018 Mar 23.
Results Reference
background
PubMed Identifier
30294295
Citation
Liao S, Deng Z, Wang Y, Jiang T, Kang Z, Tan S, Shan Y, Zou Y, Lu Z. Different Mechanisms of Two Subtypes of Perforating Artery Infarct in the Middle Cerebral Artery Territory: A High-Resolution Magnetic Resonance Imaging Study. Front Neurol. 2018 Sep 20;9:657. doi: 10.3389/fneur.2018.00657. eCollection 2018.
Results Reference
background
PubMed Identifier
26315990
Citation
Zhao DL, Deng G, Xie B, Gao B, Peng CY, Nie F, Yang M, Ju S, Teng GJ. Wall characteristics and mechanisms of ischaemic stroke in patients with atherosclerotic middle cerebral artery stenosis: a high-resolution MRI study. Neurol Res. 2016 Jul;38(7):606-13. doi: 10.1179/1743132815Y.0000000088. Epub 2016 May 9.
Results Reference
background
PubMed Identifier
19717846
Citation
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Results Reference
background
PubMed Identifier
1366259
Citation
Hansson L, Hedner T, Dahlof B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point. Blood Press. 1992 Aug;1(2):113-9. doi: 10.3109/08037059209077502.
Results Reference
background
Links:
URL
http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zgzzzz202012015
Description
Zhou LX, Ni J.Advances in Branch Atheromatous Disease. Chinese Stroke Journal 2020;15:1342- 1351
URL
http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zgzzzz201910013
Description
Chinese Stroke Association. Expert consensus on the clinical application of tirofiban in atherosclerotic cerebrovascular disease. Chinese Stroke Journal 2019;14:1034- 1044
URL
http://www.wanfangdata.com.cn/details/detail.do?_type=perio&id=zhsjk201809005
Description
Chinese Society of Neurology, Cerebrovascular disease group of Chinese Society of Neurology. Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. Chin J Neurol. 2018;51 9:666-82

Learn more about this trial

Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)

We'll reach out to this number within 24 hrs