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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The second hospital of Baoding
RECRUITING
Baoding
Beijing Shijitan Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Shunyi Hospital
RECRUITING
Beijing
Jun Ni
RECRUITING
Beijing
The First Hospital of Tsinghua University
RECRUITING
Beijing
Botou City Hospital
RECRUITING
Botou
Cangzhou Central Hospital
RECRUITING
Cangzhou
Chengde Central Hospital
RECRUITING
Chengde
Affiliated Hospital of Chifeng University
RECRUITING
Chifeng
Deyang People's Hospital
RECRUITING
Deyang
Shengli Oilfield Central Hospital
RECRUITING
Dongying
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Hengshui People's Hospital
RECRUITING
Hengshui
Jinan Central Hospital
RECRUITING
Jinan
Tibet Autonomous Region People's Hospital
RECRUITING
Lhasa
Meihekou Central Hospital
RECRUITING
Meihekou
Mianyang Central Hospital
RECRUITING
Mianyang
Yellow River SANMENXIA Hospital
RECRUITING
Sanmenxia
The First People's Hospital of Shangqiu
RECRUITING
Shangqiu
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjing
The First Affiliated Hospital of Xinxiang Medical Unversity
RECRUITING
Xinxiang
Xuzhou Central Hospital
RECRUITING
Xuzhou
The First People's Hospital of Yibin
RECRUITING
Yibin
The Second People's Hospital of Yibin
RECRUITING
Yibin
The Second Affiliated Hospital of Zhengzhou University
WITHDRAWN
Zhengzhou
Contact Information
Primary
Shengde Li, MD
lishengde.medicine@qq.com
86 17896002828
Backup
Yuhui Sha
shayh2016@126.com
86 18810678122
Time Frame
Start Date: 2023-11-09
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 516
Treatments
Experimental: Tirofiban group
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.
Active_comparator: Standard antiplatelet therapy group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Pharmaron (Chengdu) Clinical Services Co., Ltd.
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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