Multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with mechanical thrombectomy (MT), in which two therapies are compared: rt-PA or placebo. Allocation at each center will account for 1 stratum: use of alteplase (yes vs. no) before MT. Subjects will be followed up to 90 days post-randomization.
The study objective is to evaluate whether rt-PA is safe and efficient as an add-on to mechanical thrombectomy in patients with acute ischemic stroke and complete or near-complete recanalization of a proximal vessel occlusion and successful brain reperfusion on cerebral angiogram (corresponding to mTICI score 2b/3) The study is a multicenter, randomized, placebo-controlled, double blind, phase 2b trial of acute stroke patients treated with MT, in which two therapies are compared: rt-PA or placebo. Allocation at each center will account for 1 stratum: use of alteplase (yes vs. no) before MT. Subjects will be followed up to 90 days post-randomization Patients will be enrolled in the angiosuit by interventionalists or neurologists once a mTICI 2b/3 is confirmed on cerebral angiography. The primary outcome is the proportion of patients with a mRS 0 to 1 at 90 days. A sample size of 100 patients per treatment arm in a 1:1 allocation will have at least 80% statistical power for the primary outcome (mRS with 0-1 score values) assuming a rate of 40% in the control arm and a 21% benefit in the experimental arm (odds ratio (OR) of 2.33) for a 5% two-sided type I error. This sample size will also guarantee the study power for that relative treatment benefit even if the success rate in the control group rises up to ≈56%. No study losses are accounted for since all randomised patients will be included in the analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
See arm/group descriptions.
See arm/group descriptions.
Germans Trias i Pujol Hospital
Badalona, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Good outcome at 90 days
The primary outcome will be the proportion of patients with a mRS 0 to 1 at 90 days
Time frame: Day 90 after treatment.
Shift analysis of the 90-day modified Rankin Scale (mRS).
The shift analysis of the modified Rankin Scale (mRS), at day 90. The mRS at 90 days will be analyzed using a proportional odds model (POM) that combine into single worst rank the last two categories (5: severe incapacity and 6: death).
Time frame: Day 90 after treatment.
Infarct expansion ratio.
Infarct Expansion Ratio on DWI-MRI (continuous variable), at 48h (+/- 24h) of stroke
Time frame: 48 (+/- 24h) hours of stroke
Rate of infarct expansion at 24 hours.
Proportion of patients with/without infarct expansion (dichotomous variable).
Time frame: 48 (+/- 24h) hours of stroke
Final infarct volume.
Infarction Volume on Diffusion Weighted Imaging (Magnetic Resonance Imaging) at 48h (+/- 24h) of stroke onset
Time frame: 48 (+/- 24h) hours of stroke
Angiographic improvement on the Arterial Occlusive Lesion (AOL) scale
Proportion of patients with angiographic improvement on the Arterial Occlusive Lesion (AOL) scale. AOL describes arterial patency at the site of occlusion based on the degree of luminal opening (none, partial, or complete) with further qualification based simply on the presence (grades 2 or 3) or absence (grades 0 or 1) of any downstream flow.
Time frame: 10 minutes after treatment
TERTIARY OUTCOME: Barthel Scale at day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital Josep Trueta (HJT)
Girona, Spain
Barthel Scale score of 95 to 100, at day 90
Time frame: Day 90 after treatment.
TERTIARY OUTCOME: Ischemic worsening within 72 hours os stroke onset
Ischemic worsening (≥ 4 points in the NIHSS score) within 72 hours of stroke onset not attributable to stroke recurrence
Time frame: 72 hours of stroke onset
TERTIARY OUTCOME: Quality of life measured at 90 days
Quality of life measured with the EuroQol Group 5-Dimension Self-Report Questionnaire (EQ-5D-3L) at 90 days
Time frame: Day 90 after treatment.