Is intravenous alteplase still of added benefit in patients with acute ischaemic stroke who undergo intra-arterial treatment?

Not Applicable

Completed

• Conditions: Acute ischaemic stroke based on an intracranial large vessel occlusion of the anterior circulation.; Nervous System Diseases

• Registration Number: ISRCTN80619088
• Lead Sponsor: Academic Medical Centre Amsterdam

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31915166/ protocol (added 16/02/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32266543/ (added 14/04/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34758251/ (added 11/11/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35831176/ (added 14/07/2022) Other publications in https://pubmed.ncbi.nlm.nih.gov/37641554/ Post hoc analysis of association between outcomes in patients with high systolic blood pressure and prior intravenous thrombolysis (added 29/08/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-09
• Study Completion: 2021-02-05
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 539

Inclusion Criteria

1. A clinical diagnosis of acute ischaemic stroke
2. Caused by a large vessel occlusion of the anterior circulation (distal intracranial
3. Carotid artery or middle (M1/proximal M2) cerebral artery confirmed by neuroimaging
(CTA or MRA)
4. CT or MRI ruling out intracranial hemorrhage
5. Eligible for IVT (within 4.5 hours after symptom onset)
6. Ascore of at least 2 on the NIH Stroke Scale
7. Age of 18 years or older
8. Written informed consent (deferred)

Exclusion Criteria

1. Pre-stroke disability which interferes with the assessment of functional outcome at 90 days
i.e. mRS >2
2. Participation in trials other than current and MR ASAP
3. Any contra-indication for IVT, according to national guidelines, which are in accordance with guidelines of the American Heart Association, i.e.:
3.1. Arterial blood pressure exceeding 185/110 mmHg
3.2. Blood glucose less than 2.7 or over 22.2 mmol/L
3.3. Cerebral infarction in the previous 6 weeks with residual neurological deficit or signs of recent infarction on neuro-imaging
3.4. Recent head trauma
3.5. Recent major surgery or serious trauma
3.6. Recent gastrointestinal or urinary tract hemorrhage
3.7. Previous intracerebral hemorrhage
3.8. Use of anticoagulant with INR exceeding 1.7
3.9. Known thrombocyte count less than 100 x 109/L
3.10. Treatment with direct thrombin or factor X inhibitors
3.11. Treatment with therapeutic dose of (low-molecular weight) heparin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional outcome measured by the score on the modified Rankin Scale (mRS) at 90 days.