BALANCE: Concurrent thrombolysis for AIS with elevated pre-treatment BP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BALANCE trial is a multicenter randomized study in adults with acute ischemic stroke who present within 4.5 hours of onset and have pre-thrombolysis blood pressure above guideline thresholds but not extremely high. It compares initiating intravenous thrombolysis concurrently with antihypertensive management versus standard sequential BP reduction before thrombolysis. The study uses a defined BP range (above guideline thresholds but below 220 mmHg) and requires confirmation of BP by two measurements. Enrolled participants are treated at sites including West China Hospital and partner centers in Chengdu, China, under local emergency-conscreened consent procedures. Outcomes of interest include safety (e.g., hemorrhagic events) and functional recovery, with the goal of reducing door-to-needle delays and avoiding large BP fluctuations.

Why it matters

Who can join: the full rules

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.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting
• Bo Wu
  Chengdu, Sichuan, China Not yet recruiting

Study contacts

• Principal investigator: Bijoy Menon, MD, Phd — University of Calgary
• Study coordinator: Bo Wu
• Email: dr.bowu@hotmail.com
• Phone: +8618980602142

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.