Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03790800 | Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial | PHASE3 | COMPLETED | 2,425 | — | — | Mar 20, 2020 | Nov 30, 2023 | Mar 26, 2025 | 4 | China |
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
| Arm | Type | Description |
|---|---|---|
| Intervention group | EXPERIMENTAL | If systolic blood pressure\>180:IV Urapidil 25mg If systolic blood pressure\>150 (or 5 mins after first bolus) : IV Urapidil 25mg and to maintain this level after admission to hospital in those with confirmed acute stroke for the next 7 days (or hospital discharge if earlier) |
| control group | NO_INTERVENTION | To receive blood pressure management according to standard local guidelines which recommend blood pressure lowering in hospital if systolic level is \>220mmHg. This level will be considered by ambulance staff as a threshold for treatment if considered clinically important. |
| Name | Type | Description |
|---|---|---|
| urapidil | DRUG | A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists \>150 after 5 minutes. |
Inclusion Criteria: 1. age ≥18 years; 2. Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well; 3. Systolic BP ≥150 4. Able to provide brief informed consent (if a waver of consent i...