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BALANCE Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

RecruitingNAAges 18 Years - anyAllBo Wu
NCT07318948 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Elevated blood pressure (BP) is nearly universal in acute ischemic stroke (AIS) and critically influences eligibility for intravenous thrombolysis; however, current guidelines-requiring BP reduction to below 185/110 mmHg before treatment-lack robust evidence and may delay reperfusion in a time-sensitive therapy, potentially worsening outcomes. Emerging data suggest that aggressive pre-thrombolysis BP lowering does not reduce hemorrhage risk and might impair recovery, highlighting the need to avoid large BP fluctuations. Yet it remains uncertain whether initiating thrombolysis concurrently with antihypertensive therapy is safer and more effective than the standard sequential approach, particularly in patients with markedly elevated but not extreme BP (systolic \<220 mmHg). To address this gap, the BALANCE trial is a prospective, multicenter, randomized controlled study enrolling AIS pati

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Clinical diagnosis of acute ischemic stroke with a clearly defined time of symptom onset or last known well, allowing for randomization within 4.5 hours. * The treating physician has made the decision to treat the patient with intravenous thrombolysis. * Elevated blood pressure, defined as: Pre-thrombolysis BP exceeds guideline-recommended range (e.g. China: 180/100 mmHg; U.S./Canada/Europe: 185/110 mmHg), but below 220 mmHg. \*The qualifying blood pressure must be confirmed by two separate measurements taken at least one minute apart from the same arm, using an appropriately sized cuff while the patient is in a supine or semi-recumbent position. * Informed consent is obtained from the patient or a legally authorized representative in accordance with local regulations. A deferred or waiver of consent model will be used where permitted by local ethics committees for emergency research. Exclusion Criteria: * Any condition that, in the judgment of the investigator, would preclude follow-up or interfere with outcome assessment (e.g., end-stage malignancy, severe multi-organ failure). * The patient is pregnant or breastfeeding. * Concurrent enrollment in another interventional trial where the intervention is likely to confound the study endpoints.
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What it tests

  • Concurrent Thrombolysis
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Where

2 sites
West China Hospital
Chengdu, China
Bo Wu
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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