Testing Tirofiban for Stroke Caused by Branch Atheromatous Disease

Efficacy and Safety of Tirofiban in Patients With Acute Branch Atheromatous Disease (BAD)- Related Stroke (BRANT)

This study is testing if giving tirofiban to people who have had a stroke from branch atheromatous disease can help them recover better than the usual treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 26 sites (Beijing, Beijing and 25 other locations)
• Trial ID: NCT06037889 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of intravenous tirofiban in patients experiencing acute ischemic stroke due to branch atheromatous disease (BAD). It is a multicenter, randomized, open-label trial comparing tirofiban treatment to standard antiplatelet therapy within 48 hours of stroke onset. The primary goal is to determine if tirofiban can improve functional outcomes at 90 days, measured by the modified Rankin Scale. Additionally, the study will assess the rate of major bleeding events between the two treatment groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 who have experienced an acute ischemic stroke due to BAD and can be randomized within 48 hours of symptom onset.

Not a fit: Patients with strokes caused by other mechanisms or those outside the age range of 18-75 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from BAD-related strokes.

How similar studies have performed: While this approach is novel for BAD-related strokes, similar studies have shown promise in other stroke types using tirofiban.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-75 years old
2. Acute ischemic stroke
3. Time from onset to randomization ≤48h; if onset time is unknown, time from last known well to randomization ≤48h
4. 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 \[DSA\]).
5. Singed informed consent by the patient or legally authorized representatives.

Exclusion Criteria:

1. Transient ischemic attack (TIA)
2. 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;
3. Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion;
4. Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute
5. Have received or plan to receive endovascular therapy or thrombolysis after onset;
6. Stroke of other clear causes, e.g., moyamoya disease, arterial entrapment, vasculitis, etc.
7. modified Rankin Scale ≥2 before onset
8. Use of tirofiban within 1 week before or after onset
9. 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
10. Elevation of ALT or AST more than 1.5 times the upper normal limit;
11. Glomerular filtration rate \<60 ml/min/1.73m\^2
12. Known malignant tumors
13. History of trauma or major surgical intervention within 6 weeks prior to onset
14. History of intracranial hemorrhage
15. Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding)
16. Malignant hypertension (systolic blood pressure \>200 mmHg, or diastolic blood pressure \>120 mmHg)
17. Life expectancy ≤ 6 months
18. Contraindications of 3 T MRI examination
19. Pregnant or lactating women
20. Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.

Where this trial is running

Beijing, Beijing and 25 other locations

• Jun Ni — Beijing, Beijing, China (Recruiting)
• Beijing Shunyi Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Shijitan Hospital, Capital Medical University — Beijing, Beijing, China (Not_yet_recruiting)
• The First Hospital of Tsinghua University — Beijing, Beijing, China (Recruiting)
• The second hospital of Baoding — Baoding, Hebei, China (Recruiting)
• Botou City Hospital — Botou, Hebei, China (Recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Recruiting)
• Chengde Central Hospital — Chengde, Hebei, China (Recruiting)
• Affiliated Hospital of Chifeng University — Chifeng, Hebei, China (Recruiting)
• Hengshui People's Hospital — Hengshui, Hebei, China (Recruiting)
• North China University of Science and Technology Affiliated Hospital — Tangshan, Hebei, China (Recruiting)
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Yellow River SANMENXIA Hospital — Sanmenxia, Henan, China (Recruiting)
• The First People's Hospital of Shangqiu — Shangqiu, Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical Unversity — Xinxiang, Henan, China (Recruiting)
• The Second Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
• Meihekou Central Hospital — Meihekou, Jilin, China (Recruiting)
• Shengli Oilfield Central Hospital — Dongying, Shandong, China (Recruiting)
• Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
• Deyang People's Hospital — Deyang, Sichuan, China (Recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Recruiting)
• The First People's Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• The Second People's Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• The Second Hospital of Tianjin Medical University — Tianjing, Tianjing, China (Recruiting)
• Tibet Autonomous Region People's Hospital — Lhasa, Tibet, China (Recruiting)

Study contacts

• Principal investigator: Jun Ni, MD — The office for BRANT study
• Study coordinator: Shengde Li, MD

Conditions Branch Atheromatous Disease; Branch atheromatous disease; Tirofiban; Stroke; Treatment Outcome; Magnetic Resonance Imaging