PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset.
PEARL-MeVO is an investigator-initiated, multicenter, prospective, randomized controlled, open-label, blinded endpoint (PROBE) clinical trial aiming at evaluating the efficacy and safety of intra-arterial thrombolysis as adjunct to endovascular treatment in improving 90-day functional outcome in acute ischemic stroke patients due to medium vessel occlusion (MeVO) within 24 hours of symptom onset. The primary outcome is the proportion of patients with a 90-day modified Rankin Scale (mRS) of 0-1. Eligible patients will be randomly assigned at a ratio of 1:1 into the intervention group to receive intra-arterial thrombolysis as adjunct to endovascular treatment, or the control group to receive only standard medical management. A total of 530 participants (265 per group) are anticipated to be recruited for this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
530
Intra-arterial thrombolysis as adjunct to endovascular treatment, in addition to standard medical treatment
Standard medical treatment
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe modified Rankin Scale score (mRS) 0-1
The proportion of mRS 0-1 at 90 (±14) days.
Time frame: 90 (±14) days
Level of disability
The shift analysis of mRS at 90 (±14) days (mRS 5 and 6 merged)
Time frame: 90 (±14) days
The modified Rankin Scale score (mRS) 0-2
The proportion of mRS 0-2 at 90 (±14) days;
Time frame: 90 (±14) days
Quality of life (EQ-5D-5L)
Quality of life measured by the EQ-5D-5L scale score at 90 (±14) days
Time frame: 90 (±14) days
Neurologic deficit (NIHSS score) changes
The change of NIHSS score from baseline at 24 (±12) hours
Time frame: 24 (±12) hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.