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.
This is a single-center randomized controlled study conducted to explore the efficacy and safety of antithrombotic therapy with regulation of blood pressure in non-cardioembolic PIS. We plan to recruit 70 patients with non-cardioembolic PIS. All subjects are of Han ethnicity, aged 18 years or older. Gender and age will be statistical data after enrollment. Patients will participate in the study after informed consent. Then patients who meet the inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to the control group (antithrombotic therapy) or the intervention group (antithrombotic + blood pressure control therapy). In addition to antithrombotic therapy, the intervention group will use medications such as dopamine, metaraminol, or midodrine to control systolic blood pressure within the range of 160-180 mmHg and maintain it for one week. Patients will be followed up at 2 weeks for mRS (Modified Rankin Scale) and NIHSS (National Institutes of Health Stroke Scale) scores，and at one month for mRS scores, and at three months for mRS and BI (Barthel Index) scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
70
After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term. In terms of blood pressure control, medications such as dopamine, metaraminol, or midodrine are used to achieve a systolic blood pressure target range of 160-180 mmHg within 1 h of random assignment and to maintain this target for 7 days (or death, should this event occur earlier). BP measurements are routinely captured using automated devices fitted to the unaffected arm, following the protocol recommended by the standard guideline. The readings are taken at 15-minute intervals for the initial hour, hourly from the first to the sixth hour, every six hours from 6 to 24 hours, and then twice daily for 7 days (or death, if earlier). Subsequently, these data are uploaded into the research database.
After stroke progression, all patients receive dual antiplatelet therapy (aspirin 100mg/day combined with clopidogrel 75mg/day) for the first 21 days, except in cases of cerebral hemorrhage. After this period, they continue to take aspirin 100mg/day orally for the long term.
Ruijin North Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
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.
Time frame: at 90 days after randomization
proportion of patients with outcome measured by the Barthel index (BI)
outcome measured by the Barthel index (BI)，≥ 95 for the BI
Time frame: at 90 days after randomization
proportion of patients with outcome measured by mRS
outcome measured by mRS，0-2 for mRS
Time frame: at 90 days after randomization
proportion of patients with an excellent outcome
proportion of patients with an excellent outcome（0-1 for the mRS）
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: at 90 days after randomization
proportion of patients with any bleeding
any bleeding，such as nasal bleeding, gingival bleeding, skin ecchymosis, etc.
Time frame: at 90 days after randomization
proportion of patients with death
all cause of death
Time frame: at 90 days after randomization
proportion of patients with adverse events
adverse events，such as allergic reaction，symptoms of hypertensive encephalopathy，etc.
Time frame: 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.
Time frame: at 90 days after randomization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.