Giving clot-dissolving treatment together with blood pressure lowering in acute ischemic stroke
Compares starting clot-dissolving treatment alongside blood pressure lowering versus after it, in stroke.
Plain-language title generated from the registry record
Registry title: BALANCE Trial Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Key facts
- Where
- Chengdu, ChinaSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a stroke caused by a blocked blood vessel, started within 4.5 hours, who need a clot-dissolving drug and have high blood pressure.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke with a known start time or last time seen well, so that randomization can happen within 4.5 hours. Blood pressure above the local guideline limit (for example 180/100 mmHg in China, 185/110 mmHg in the U.S., Canada and Europe) but below 220 mmHg, confirmed by two measurements.
- Earlier treatment
- The treating doctor has decided to give the clot-dissolving drug (intravenous thrombolysis).
Main reasons for not taking part
- Any condition that would prevent follow-up or interfere with measuring outcomes, such as end-stage cancer or severe failure of several organs
- Pregnant or breastfeeding
- Taking part in another interventional trial that could confound the results
Read by machine on 9 November 2026.
Where in China
- Bo WuChengdu, ChinaNot yet recruiting
- West China HospitalChengdu, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bo Wu
- Trial code
- NCT07318948
- Record updated
- 1 September 2026
- Original description
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).Read full original descriptionShow less
BALANCE Trial Protocol - Blood Pressure Lowering and Thrombolysis: Concurrent vs Sequential Management in Acute Ischemic Stroke
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.
Inclusion: 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: Concurrent enrollment in another interventional trial where the intervention is likely to confound the study endpoints; 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.