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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05701956




Registration number
NCT05701956
Ethics application status
Date submitted
18/01/2023
Date registered
27/01/2023
Date last updated
1/10/2024

Titles & IDs
Public title
Intravenous Tenecteplase Plus EVT Versus EVT Alone on 4.5 to 24 Hours After Basilar Artery Occlusion
Scientific title
Intravenous Tenecteplase Plus Endovascular Thrombectomy Versus Endovascular Thrombectomy Alone on 4.5 to 24 Hours After Stroke Due to Basilar Artery Occlusion -a Multicenter, Randomized Controlled, Clinical Trial
Secondary ID [1] 0 0
ATTENTION LATE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Basilar Artery Occlusion 0 0
Acute Cerebrovascular Accident 0 0
Stroke Due to Basilar Artery Occlusion 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase
Treatment: Surgery - Endovascular thrombectomy

Experimental: Intravenous tenecteplase+endovascular thrombectomy - Patients will receive intravenous tenecteplase (0.25mg/kg, max 25mg) plus endovascular thrombectomy.

Active comparator: Endovascular thrombectomy alone - Patients will receive endovascular thrombectomy alone.


Treatment: Drugs: Tenecteplase
Patients will receive intravenous tenecteplase (0.25mg/kg, maximum 25mg, administered as a bolus over 5-10 seconds) before endovascular thrombectomy

Treatment: Surgery: Endovascular thrombectomy
The choice of endovascular thrombectomy strategy will be made by the treating neurointerventionist. All thrombectomy devices for endovascular treatment, which are approved by CFDA for this purpose, are allowed in the trial.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients with modified Rankin Score 0-2 at day 90 (±14 days)
Timepoint [1] 0 0
90 (± 14 days) after procedure
Secondary outcome [1] 0 0
Proportion of patients with modified Rankin Score 0-3 at day 90 (±14 days)
Timepoint [1] 0 0
90 (± 14 days) after procedure
Secondary outcome [2] 0 0
Ordinal Shift analysis of modified Rankin Score at day 90 (±14 days)
Timepoint [2] 0 0
90 (± 14 days) after procedure
Secondary outcome [3] 0 0
Score on the NIHSS at 24 hours
Timepoint [3] 0 0
24 hours after procedure
Secondary outcome [4] 0 0
Score on the NIHSS at 5-7 days or discharge
Timepoint [4] 0 0
5-7 days or discharge after procedure
Secondary outcome [5] 0 0
Proportion of patients with modified Rankin Score 0-1 at day 90 (±14 days)
Timepoint [5] 0 0
90 (± 14 days) after procedure
Secondary outcome [6] 0 0
Proportion of patients with modified Rankin Score 0-4 at day 90 (±14 days)
Timepoint [6] 0 0
90 (± 14 days) after procedure
Secondary outcome [7] 0 0
Score on the EuroQoL 5-dimensions 5-level (EQ5D-5L) at 90 days (±14 days)
Timepoint [7] 0 0
90 (± 14 days) after procedure
Secondary outcome [8] 0 0
level of activities of daily living (Barthel index, BI) at 90 days (±14 days)
Timepoint [8] 0 0
90 (± 14 days) after procedure
Secondary outcome [9] 0 0
Successful reperfusion (Extended thrombolysis in cerebral infarction [eTICI] score 2b50-3) on digital substraction angiography (DSA) prior to thrombectomy
Timepoint [9] 0 0
within 5 minutes at angiography
Secondary outcome [10] 0 0
Successful reperfusion on final angiography of thrombectomy
Timepoint [10] 0 0
Within 5 minutes at final angiography of thrombectomy
Secondary outcome [11] 0 0
Successful recanalization on CT or MR angiography within 72 hours
Timepoint [11] 0 0
Within 72 hours after procedure
Secondary outcome [12] 0 0
Infarct volume (Posterior Circulation Acute Stroke Prognosis Early Computed Tomography Score, PC-ASPECTS) evaluated on CT or MRI within 72 hours
Timepoint [12] 0 0
Within 72 hours after procedure

Eligibility
Key inclusion criteria
1. Patients presenting with posterior circulation ischemic stroke symptoms due to basilar artery occlusion or vertebral artery occlusions that prevent antegrade flow into the basilar artery;
2. Time from stroke onset to randomization within 4.5-24 hours of estimated time of basilar artery occlusion;
3. Patient's age=18 years;
4. Presence of basilar artery or vertebral artery occlusion, confirmed by CT Angiography (CTA), MR Angiography (MRA) or Digital Subtraction Angiography (DSA). In cases of vertebral artery occlusion, the occlusion must completely prevent antegrade flow into the basilar artery;
5. Patients presenting with acute ischemic stroke eligible using standard criteria (except for time window) to receive both endovascular thrombectomy and intravenous thrombolysis;
6. Baseline National Institutes of Health Stroke Scale (NIHSS) score= 10 at the time of neuroimaging;
7. The patient or patient's legal representative signs the informed consent form.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. CT or MR evidence of intracerebral hemorrhage (the presence of < 10 microbleeds is allowed);
2. Pre-stroke modified Rankin scale (mRS) score of = 2;
3. Posterior circulation Acute Stroke Prognosis Early CT Score (PC-ASPECTS) on CT/ CTA-Source Images<6; PC-ASPECTS on magnetic resonance imaging-diffusion weighted imaging (MRI-DWI) <5;
4. Pregnant or lactating women;
5. Allergy to contrast agent or nitinol alloy;
6. Life expectancy<1 year;
7. CTA/MRA/DSA show vascular tortuosity, vascular variation or artery dissection, which would make it difficult to perform endovascular treatment;
8. Participating in other clinical trials;
9. Systolic blood pressure >185 mmHg or diastolic blood pressure >110 mmHg, which cannot be controlled by antihypertensive drugs;
10. Genetic or acquired hemorrhagic diathesis, lack of anticoagulant factor; or oral anticoagulant with international normalized ratio (INR) > 1.7, or novel oral anticoagulant within prior 48 hours;
11. Blood glucose <50 mg/dl (2.8 mmol/L) or >400 mg/dl (22.2 mmol/L), platelet< 100*109/L;
12. Renal insufficiency defined as serum creatinine >2.0 mg/dl (or 176.8 µ mol/l) or a glomerular filtration rate <30 mL/min or the need for hemodialysis or peritoneal dialysis;
13. Patients who cannot complete 90-day follow-up (such as patients without fixed residence, overseas patients, etc);
14. The patient has acute ischemic cerebral infarction within 3 months from randomization;
15. The patient had a history of or clinical suspicion for cerebral vasculitis or infectious endocarditis;
16. The patient has nervous system disease or mental disorder before stroke onset, which may affect the assessment of their condition;
17. CT or MR examination showed large cerebellar infarction with obvious space occupying effect and compression of the fourth ventricle;
18. Patients with extensive bilateral thalamic or extensive bilateral brainstem infarction on CT or MR examination;
19. CTA/MRA/DSA show both anterior and posterior circulation large vessel occlusion;
20. Patients with intracranial tumors (except small meningiomas);
21. Patients who received intravenous thrombolytics treatment before the randomization;

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2026
Actual
Sample size
Target
332
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Anhui

Funding & Sponsors
Primary sponsor type
Other
Name
The First Affiliated Hospital of University of Science and Technology of China
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To assess the effect of intravenous tenecteplase plus endovascular thrombectomy (EVT) compared to EVT alone on 4.5 to 24 hours after stroke due to basilar artery occlusion.
Trial website
https://clinicaltrials.gov/study/NCT05701956
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Wei Hu, MD
Address 0 0
The First Affiliated Hospital of University of Science and Technology of China
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wei Hu, MD
Address 0 0
Country 0 0
Phone 0 0
+8615155510611
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05701956