Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

Ischemic stroke is a major health burden globally and in Australia. Treatment for ischemic stroke is time critical and is significantly more effective if administered within the first 90 minutes of symptom onset. This clinical trial will identify if early administration of oral thrombolytic agent, tenecteplase prior to hospital can improve outcomes from stroke, and reduce costs compared to standard care of IV alteplase in hospital

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Melbourne Health
• Collaborator: Austin Health, Eastern Health, Monash Health, Western Health, Alfred Health
• Treatments: Plasminogen; Tenecteplase; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

1. Patients being attended by the mobile stroke unit with an acute ischemic stroke eligible for thrombolysis using standard clinical and CT criteria.

2. Patient's age is ≥18 years

3. Premorbid mRS <4

Exclusion Criteria:

1. Intracranial hemorrhage (ICH) or other diagnosis (e.g. tumor) identified by CT on the MSU

2. Hypodensity in >1/3 MCA territory or equivalent proportion of ACA or PCA territory on non-contrast CT on MSU

3. Pre-stroke mRS score of > 3 (indicating significant previous disability)

4. Any terminal illness such that patient would not be expected to survive more than 1 year

5. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

6. Pregnant women.

7. Rapidly improving symptoms.