ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632

Launched by UNIVERSITY OF CALGARY · Mar 12, 2024

Keywords

ClinConnect Summary

The ACT-GLOBAL THROMBOLYSIS trial is studying how well different doses of a treatment called tenecteplase work for patients who have had an acute ischemic stroke (AIS), which is a type of stroke caused by a blockage in the blood vessels supplying the brain. The trial compares a standard dose of tenecteplase (0.25 mg/kg) to a lower dose (0.18 mg/kg) to see which is more effective and safe for patients. It also looks at how to use these treatments in patients who have recently taken certain blood thinners or are planning to undergo a specific procedure called endovascular thrombectomy, which is used to remove blood clots. By studying these different scenarios, the trial aims to provide better guidance for doctors in treating stroke patients.

To participate in the trial, patients must be between 65 and 74 years old and have experienced a disabling acute ischemic stroke within the last 4.5 hours. They should be considered for treatment with intravenous thrombolysis (IVT) using tenecteplase, even if there are some cautionary guidelines in place. Participants will be monitored for 90 days, or until they pass away if that occurs sooner. The trial is currently recruiting, and it is important to note that patients with certain serious conditions, like active bleeding or recent major surgery, will not be eligible. This trial represents an important step in finding the best ways to treat strokes, which can significantly affect recovery and quality of life.

Gender

ALL

Eligibility criteria

• 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.