Stroke is a leading global cause of disability and mortality, necessitating the development of novel treatment strategies to enhance recovery outcomes. One promising therapeutic candidate is bupropion hydrochloride, a norepinephrine–dopamine reuptake inhibitor that may help facilitate both motor and cognitive recovery due to its distinct mechanism of action. This study aims to assess the efficacy and safety of early adjunctive treatment with bupropion compared to a placebo, targeting functional recovery in patients experiencing acute ischaemic stroke.
The BASE trial will be an investigator-initiated, multicentre, double-blind randomized controlled trial. The goal is to enroll approximately 1054 patients diagnosed with acute ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) scores of 8 to 15, within 2 to 7 days post-onset) from about 40 stroke centers throughout China. Participants will be assigned in a 1:1 ratio to receive either oral bupropion hydrochloride (75 mg, administered twice daily) or matched placebo for a duration of 30 days, alongside standard guideline-based care.
The primary efficacy endpoint will focus on the proportion of patients achieving a favorable functional outcome, characterized by a modified Rankin Scale (mRS) score of 0 to 3 at 90 days. Additionally, secondary endpoints will include shifts in mRS scores, changes in NIHSS scores, and evaluations of quality of life using the EQ-5D scale. Safety endpoints will assess mortality rates, vascular events, and the incidence of adverse events.
Approval for the study protocol has been granted by the Ethics Committee of the First Affiliated Hospital of Chongqing Medical University, and all participants will provide written informed consent prior to enrollment. Findings will be disseminated through peer-reviewed journals and relevant academic conferences.
Eligible participants will undergo randomization using computer-generated sequences stratified by center. Treatments will be masked, ensuring that all study personnel, investigators, and participants are unaware of treatment assignments during the entirety of the trial. The bupropion and placebo tablets will appear identical in all respects.
Participants assigned to the bupropion group will receive bupropion hydrochloride (75 mg) twice daily for 30 days.
Those in the placebo group will receive identically matched placebo tablets, adhering to the same schedule for 30 days.
All participants will follow guideline-based management for acute ischaemic stroke, including antiplatelet therapy, statins, and other appropriate vascular risk interventions as directed by the neurologist.
Patient assessments will occur at baseline, day 7, day 30, and day 90, encompassing clinical evaluations of motor function, neurological impact, and quality of life. Follow-up visits will continue to monitor adverse events and treatment adherence.
The primary endpoint is the proportion of participants with a favorable functional outcome (mRS score 0-3) at 90 days.
Secondary endpoints will monitor the trend toward functional independence (mRS 0-2) at respective time points and document significant neurological improvements.
The study establishes robust safety monitoring to address risks associated with bupropion, including managing potential hypertension. Each participant’s blood pressure will be closely tracked with predefined protocols for elevation management. A systematic approach will classify blood pressure readings and determine necessary clinical interventions.
The comprehensive approach of the BASE trial seeks to rigorously evaluate whether bupropion hydrochloride can significantly enhance recovery in individuals affected by acute ischaemic stroke. The outcomes of this trial may inform future therapeutic strategies for improving post-stroke rehabilitation.