Antithrombotic Therapy With Regulation of Blood Pressure in Non-Cardioembolic Progressive Stroke
NCT Number: NCT06551727
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke, Ischemic
Interventions: OTHER: Intervention group|OTHER: Control group
Sponsor: Ruijin Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-07-31
Locations: Ruijin North Hospital of Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai, 201800, China

Summary:
Stroke has become the leading cause of death in China, with acute ischemic stroke still progressing within one week of onset, known as progressive ischemic stroke (PIS), which has a high rate of disability and mortality, accounting for 23-43% of the incidence of stroke. Non-cardioembolic PIS is one of the common types, and the current treatment mainly focuses on antithrombotic therapy, but the therapeutic effect is not satisfactory. More and more evidence suggests that hypotension is an unfavorable factor for PIS, so this study intends to explore the efficacy and safety of antithrombotic therapy with regulation of blood pressure in non-cardioembolic PIS.

Primary Outcome Measures: percentage of patients with an excellent outcome（mRS score 0-1）at 90 days after randomization, modified Rankin scale (mRS，an ordinal global disability scale with scores ranging from 0 \[no symptoms\] to 6 \[death\]) at 90 days after randomization. An excellent outcome is defined as score of 0 or 1 on the mRS score at 90 days., at 90 days after randomization
Secondary Outcome Measures: proportion of patients with outcome measured by the Barthel index (BI), outcome measured by the Barthel index (BI)，≥ 95 for the BI, at 90 days after randomization|proportion of patients with outcome measured by mRS, outcome measured by mRS，0-2 for mRS, at 90 days after randomization|proportion of patients with an excellent outcome, proportion of patients with an excellent outcome（0-1 for the mRS）, at 2 weeks after randomization and at day 30 after randomization|proportion of patients with functional independence, proportion of patients with functional independence (0-2 for the mRS), at 2 weeks after randomization and at day 30 after randomization|proportion of patients with outcome measured by NIHSS, outcome measured by NIHSS (0-1 for the NIHSS), at 2 weeks after randomization|proportion of patients with severe or moderate bleeding, severe or moderate bleeding，as defined by the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) criteria, at 90 days after randomization|proportion of patients with any bleeding, any bleeding，such as nasal bleeding, gingival bleeding, skin ecchymosis, etc., at 90 days after randomization|proportion of patients with death, all cause of death, at 90 days after randomization|proportion of patients with adverse events, adverse events，such as allergic reaction，symptoms of hypertensive encephalopathy，etc., at 90 days after randomization|proportion of patients with severe adverse events, severe adverse events, as defined by serious drug side effects and serious unexpected events during the study., at 90 days after randomization