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

Phase 3

Recruiting

• Conditions: Branch Atheromatous Disease

• Registration Number: NCT06037889
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-9-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Age: 18-75 years old<br><br> 2. Acute ischemic stroke<br><br> 3. Time from onset to randomization =48h; if onset time is unknown, time from last<br> known well to randomization =48h<br><br> 4. Meet the following BAD Diagnostic Imaging Criteria<br><br> 4.1. DWI infarcts: single (isolated) deep (subcortical) infarcts;<br><br> 4.2. The culprit arteries are either Lenticulostriate artery (LSA) or Paramedian<br> pontine artery (PPA), and the infarct lesion on DWI conforms to one of the following<br> characteristics (A/B): A. LSA: 1) Comma-like infarct lesions with Fan-shaped<br> extension from bottom to top in the coronary position; or 2) = 3 layers (layer<br> thickness 5-7 mm) on axial DWI brain images; B. PPA: The infarct lesion extends from<br> the deep pons to the ventral pons on the axial DWI brain images;<br><br> 4.3. No more than 50% stenosis on the parent artery of the criminal artery (i.e.<br> corresponding basilar or middle cerebral artery) (Confirmed by magnetic resonance<br> angiography [MRA] or computed tomography angiography [CTA] or digital substraction<br> angiography [DSA]).<br><br> 5. Singed informed consent by the patient or legally authorized representatives.<br><br>Exclusion Criteria:<br><br> 1. Transient ischemic attack (TIA)<br><br> 2. Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain<br> abscesses, malignant space-occupying lesions, or other non-ischemic intracranial<br> lesions detected by baseline CT/MRI, or MRA/CTA/DSA;<br><br> 3. Presence of =50% stenosis in extracranial artery in tandem relationship ipsilateral<br> to the lesion;<br><br> 4. Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve<br> disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block<br> disease, heart rate less than 50 beats per minute<br><br> 5. Have received or plan to receive endovascular therapy or thrombolysis after onset;<br><br> 6. Stroke of other clear causes, e.g., moyamoya disease, arterial entrapment,<br> vasculitis, etc.<br><br> 7. modified Rankin Scale =2 before onset<br><br> 8. Use of tirofiban within 1 week before or after onset<br><br> 9. Low platelets (<100×10^9 /L), or Prothrombin time >1.3 times of the upper normal<br> limit, or INR >1.5, or other systemic hemorrhagic tendencies such as hematologic<br> disorders<br><br> 10. Elevation of ALT or AST more than 1.5 times the upper normal limit;<br><br> 11. Glomerular filtration rate <60 ml/min/1.73m^2<br><br> 12. Known malignant tumors<br><br> 13. History of trauma or major surgical intervention within 6 weeks prior to onset<br><br> 14. History of intracranial hemorrhage<br><br> 15. Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g.,<br> gastrointestinal bleeding)<br><br> 16. Malignant hypertension (systolic blood pressure >200 mmHg, or diastolic blood<br> pressure >120 mmHg)<br><br> 17. Life expectancy = 6 months<br><br> 18. Contraindications of 3 T MRI examination<br><br> 19. Pregnant or lactating women<br><br> 20. Have participated in another clinical trial within 3 months prior to the date of<br> informed consent, or are participating in another clinical trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Excellent functional outcome

Secondary Outcome Measures

Name	Time	Method
Excellent functional outcome;Early neurological deterioration;NIHSS score;Barthel index score;Ischemic stroke;Stroke;TIA;Composite endpoint;Proportion of Major bleeding;Serious adverse events;Adverse events;All-cause death;Changes in hemoglobin;Changes in the count of red blood cell;Changes in the count of white blood cell;Changes in the count of platelets;Changes in alanine transaminase;Changes in aspartate aminotransferase;Changes in direct bilirubin;Changes in indirect bilirubin;Changes in concentration of Na;Changes in the concentration of K;Changes in the concentration of creatinine;Changes in the concentration of albumin;Changes in the urinary occult blood;Changes in the fecal occult blood