Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Pharmaron (Chengdu) Clinical Services Co., Ltd.
Conditions:
Branch Atheromatous Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ...
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 differen...
Eligibility Criteria
Inclusion
- 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
- 1. DWI infarcts: single (isolated) deep (subcortical) infarcts;
- 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;
- 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
- 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.
Key Trial Info
Start Date :
November 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2026
Estimated Enrollment :
516 Patients enrolled
Trial Details
Trial ID
NCT06037889
Start Date
November 9 2023
End Date
March 20 2026
Last Update
January 7 2026
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
2
Beijing Shunyi Hospital
Beijing, Beijing Municipality, China, 101300
3
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
4
The First Hospital of Tsinghua University
Beijing, Beijing Municipality, China