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Multicenter Study
. 2024 Jun 10;14(6):e082141.
doi: 10.1136/bmjopen-2023-082141.

Efficacy and safety of tirofiban in patients with acute branch atheromatous disease-related stroke (BRANT): a protocol for a randomised controlled trial

Shengde Li  1 , Dingding Zhang  2 , Yuhui Sha  1 , Yicheng Zhu  1 , Lixin Zhou  1 , Bin Peng  1 , Jun Ni  3
Affiliations
Multicenter Study

Efficacy and safety of tirofiban in patients with acute branch atheromatous disease-related stroke (BRANT): a protocol for a randomised controlled trial

Shengde Li et al. BMJ Open. .

Abstract

Introduction: Branch atheromatous disease (BAD)-related stroke is increasingly becoming a clinical entity and prone to early neurological deterioration (END) and poor prognosis. There are no effective regimens to reduce the disability caused by BAD-related stroke in acute phase. Recent studies have indicated the efficacy of tirofiban in acute ischaemic stroke; however, its efficacy has not been validated in patients with BAD-related stroke. Thus, we aim to test whether intravenous tirofiban initiated within 48 hours after the onset would improve the functional outcome in patients with acute BAD-related stroke, in comparison with the standard antiplatelet therapy based on the current guideline.

Methods and analysis: BRANT is a multicentre, randomised, open-label, blinded endpoint, parallel-controlled, phase III trial conducted in 21 hospitals in China. Participants aged 18-75 years with acute BAD-related stroke within 48 hours after the stroke onset are randomised in a 1:1 ratio to the tirofiban or control group. The treatment period is 48 hours in both groups. The primary outcome is the excellent functional outcome (modified Rankin Scale Score: 0-1) at 90 days. The secondary outcomes include END, major bleeding, stroke, death, functional status, serious adverse events and change in bleeding-related markers. Assuming the rates of the primary outcome to be 74% in the tirofiban group and 62% in the control group, a total of 516 participants are needed for 0.8 power (two-sided 0.05 alpha).

Ethics and dissemination: BRANT study has been approved by the Ethics Committee of the Peking Union Medical College Hospital (I-23PJ1242). Written informed consent is required for all the patients before enrolment. The results of the study will be published in a peer-reviewed journal.

Trial registration number: ClinicalTrials.gov (NCT06037889).

Keywords: Prognosis; Stroke; THERAPEUTICS.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow. BAD, branch atheromatous disease.
See this image and copyright information in PMC

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