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

Condition(s) studied

Investigational drug(s) / intervention(s)

Concurrent Thrombolysis: Lowering the blood pressure and undergoing thrombolysis at the same time while the partipants blood pressure is higher than 185/110 mmHg or 180/100 mmHg.

Study summary

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 patients within 4.5 hours of onset whose pre-thrombolysis BP exceeds regional guideline thresholds (e.g., \>180/100 mmHg in China or \>185/110 mmHg internationally) but is \<220 mmHg and who are otherwise eligible for thrombolysis. Patients are randomized to either: (1) concurrent management-immediate thrombolysis with simultaneous IV antihypertensive therapy to gradually lower BP-or (2) sequential management-antihypertensive treatment first, followed by thrombolysis only after BP reaches target. The primary endpoint is a hierarchical composite analyzed using the win ratio, prioritizing: (1) functional outcome (90-day mRS distribution), (2) major safety (symptomatic intracerebral hemorrhage within 7 days per SITS-MOST criteria), and (3) process efficiency (door-to-needle time).

Conducted across 80-100 global stroke centers, BALANCE aims to provide definitive evidence to optimize BP management and improve outcomes in AIS patients with elevated BP.

Eligibility

Primary outcome measure(s)

• Primary Endpoint: A Justification for the Hierarchical Win Ratio — 90-day
  The win ratio is a patient-centered statistical method that allows for the comparison of treatment arms across several prioritized outcomes. It provides a more holistic assessment of the net clinical benefit. The hierarchy is ordered based on clinical importance: 1. Functional Outcome: Defined as the distribution in scores on the modified Rankin scale (mRS) at 90 days after randomization. 2. Major Safety: Defined as the sICH occurrence within 7 days after randomization, based on SITS-MOST criteria. Process Efficiency: Defined as the time between emergency department entry to thrombolysis start (DNT).

Trial sites (2)

More Bo Wu trials in China

Other trials for the same condition