Ischemic Stroke
Conditions
Interventions
Concurrent Arm:1.Thrombolysis: Immediately after randomization, intravenous thrombolysis (alteplase or tenecteplase, per local standard of care) is administered as per local practice.
2.Antihypertens
U.S./Canada/Europe: 185/110 mmHg).
Sequential Arm:1.Antihypertensive Therapy: Immediately after randomization, intravenous antihypertensive therapy is initiated to actively lower the patients blood pressure to below the guideline recom
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. The clinical diagnosis is acute ischemic stroke, and the onset time or the last normal time of symptoms is clear, and randomization can be completed within 4.5 hours. 3. The researcher (attending physician) has decided to administer intravenous thrombolytic therapy to the patient. 4. The blood pressure before thrombolysis exceeded the recommended range of the local guidelines (Chinese guidelines: 180/100 mmHg; American/European guidelines: 185/110 mmHg), and was lower than 220 mmHg; 5. The patient or their guardian signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. There are other diseases that interfere with clinical outcomes or follow-up evaluations (end-stage cancer, end-stage heart disease, liver failure, renal failure, lung failure, etc.); 2. Pregnant or lactating women; 3. Currently participating in other clinical trials simultaneously and influencing the assessment of clinical prognosis;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for this trial is a hierarchical composite endpoint analyzed using the win ratio. 1. 90-day Functional Outcome (mRS); 2.Major Safety (sICH); 3. Process Efficiency (door-to-needle time (DNT)); | — |
Secondary
| Measure | Time frame |
|---|---|
| 90-day Excellent Functional Outcome (mRS 0-1);90-day Good Functional Outcome (mRS 0-2);Distribution of 90-day mRS;90-day life quality (EQ-5D-5L score);Neurological function level 72 hours after randomization: NIHSS score 72+/-12 hours after randomization;Early improvement in neurological function (NIHSS score of 0-1 at 72+/-12 hours after randomization or a reduction of >=4 points in the total NIHSS score compared to baseline);90-day all-cause mortality;Malignant Cerebral Edema: The incidence of malignant edema, adjudicated by the central imaging core lab according to follow-up imaging and medical history.;Process Metrics: DNT, Door-to-Antihypertensive Start Time, Door-to-Target BP Time, Time-in-Range for SBP 140–180 mmHg, BP Variability over 24 hours.; | — |
Countries
China
Contacts
Public ContactBo Wu
West China Hospital of Sichuan University
Outcome results
None listed