Comparing different doses of tenecteplase for treating acute ischemic stroke

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

This clinical trial aims to evaluate the effectiveness of standard-dose versus low-dose intravenous tenecteplase in patients with acute ischemic stroke. It employs a randomized, controlled, open-label design with blinded endpoint assessment, enrolling up to 4,000 patients who present to hospitals within 4.5 hours of symptom onset. Participants will be followed for 90 days to assess outcomes related to stroke recovery and safety. The trial also investigates the use of tenecteplase in conjunction with endovascular thrombectomy when necessary.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. All patients with disabling AIS presenting within 4.5 hours of symptom onset or last known well who may benefit from intravenous thrombolysis (IVT) with tenecteplase. Patients potentially eligible for IVT with conditions described as relative contraindications in national guidelines where physician discretion is recommended are eligible. Patients who received a DOAC, and those planned for emergency EVT are eligible.
2. Consent process completed as per national laws and regulation and the applicable ethics committee requirements.

Exclusion Criteria:

1. Any absolute contraindication for IV thrombolysis per current national guidelines. Examples include those who are actively bleeding, had recent intracranial surgery, head trauma, intracranial or subarachnoid hemorrhage, or a bleeding diathesis.
2. Minor stroke patients with non-disabling symptoms.

Where it's running

• Royal Prince Alfred Hospital
  Sydney, New South Wales, Australia Recruiting
• Monash University (Box Hill)
  Melbourne, Victoria, Australia Recruiting
• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of Alberta
  Edmonton, A, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting
• University of Manitoba - Winnipeg Health Science Centre
  Winnipeg, Manitoba, Canada Recruiting

Study contacts

• Principal investigator: Bijoy K Menon, MD, MSc — University of Calgary
• Study coordinator: Bijoy K Menon, MD, MSc
• Email: bkmmenon@ucalgary.ca
• Phone: 4039448107

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inter-Limb Transfer after Acute Stroke

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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.