NCT06037889CompletedPhase 3
Efficacy and Safety of Tirofiban for Patients With BAD (BRANT)
Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT)
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 516 (actual)
- First submitted
- 7 Sept 2023
- Start date
- 9 Nov 2023
- Primary completion date
- 26 Feb 2026
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Stroke
- NCT number
- NCT06037889
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 516
- From 9 Nov 2023 to the primary completion date, 26 Feb 2026
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received or plan to receive endovascular therapy or thrombolysis after onset;
- Use of tirofiban within 1 week before or after onset
- History of trauma or major surgical intervention within 6 weeks prior to onset
- Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding)
- Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.
Other illness
- 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;
- Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute
- Stroke of other clear causes, e.g., moyamoya disease, arterial dissection, vasculitis, etc.
- Known malignant tumors
- History of intracranial hemorrhage
- Malignant hypertension (systolic blood pressure \>200 mmHg, or diastolic blood pressure \>120 mmHg)
Lab values
- 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;
Other
- Transient ischemic attack (TIA)
- Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion;
- modified Rankin Scale ≥2 before onset
- Glomerular filtration rate \<60 ml/min/1.73m\^2
- Life expectancy ≤ 6 months
- Contraindications of 3 T MRI examination
- Pregnant or lactating women
Who the study is looking for
- 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 coronal plane; 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second hospital of Baoding Coordinator of this site? Confirm its status | Baoding | China | Unknown status |
| The First Hospital of Tsinghua University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Shijitan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Shunyi Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Botou City Hospital Coordinator of this site? Confirm its status | Botou | China | Unknown status |
| Cangzhou Central Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Unknown status |
| Chengde Central Hospital Coordinator of this site? Confirm its status | Chengde | China | Unknown status |
| Affiliated Hospital of Chifeng University Coordinator of this site? Confirm its status | Chifeng | China | Unknown status |
| Deyang People's Hospital Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Shengli Oilfield Central Hospital Coordinator of this site? Confirm its status | Dongying | China | Unknown status |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Hengshui People's Hospital Coordinator of this site? Confirm its status | Hengshui | China | Unknown status |
| Jinan Central Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Tibet Autonomous Region People's Hospital Coordinator of this site? Confirm its status | Lhasa | China | Unknown status |
| Meihekou Central Hospital Coordinator of this site? Confirm its status | Meihekou | China | Unknown status |
| Mianyang Central Hospital Coordinator of this site? Confirm its status | Mianyang | China | Unknown status |
| Yellow River Sanmenxia Hospital Coordinator of this site? Confirm its status | Sanmenxia | China | Unknown status |
| The First People's Hospital of Shangqiu Coordinator of this site? Confirm its status | Shangqiu | China | Unknown status |
| North China University of Science and Technology Affiliated Hospital Coordinator of this site? Confirm its status | Tangshan | China | Unknown status |
| The Second Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjing | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical Unversity Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuzhou Central Hospital Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| The First People's Hospital of Yibin Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| The Second People's Hospital of Yibin Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
Related publications
- Tirofiban vs standard antiplatelet therapy in acute branch atheromatous disease-related stroke: a multicenter, randomized, open-label, blinded-endpoint, parallel-group, phase III clinical trial.Lancet Reg Health West Pac · 2026 · PMID 42894564
This page is information, not medical advice. Discuss any trial with your doctor.