Acute Ischemic Stroke, Stroke, Thrombolysis
Conditions
Keywords
acute ischemic stroke, blood pressure, thrombolysis
Brief summary
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment setting on the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, with a key focus on the incidence of symptomatic intracranial hemorrhage (sICH).
Detailed description
This study is a Phase II, exploratory, prospective, multicenter, open-label, randomized controlled clinical trial with blinded endpoint assessment. EAST-BP aims to investigate the safety of an adjusted versus a conventional blood pressure management strategy during intravenous thrombolysis in AIS patients, according to an ordinal analysis of Proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis, proportion of severe or life-threatening major hemorrhage, DNT time for intravenous thrombolysis patients, proportion of independent functional prognosis at 90 days (90-day mRS 0-2), sequential analysis of improved 90-day mRS score for patients, proportion of death at 90 days, and neurological function status at 7 days or at discharge (if hospital stay is less than 7 days) .
Interventions
PROCEDUREAdjusted BP management group
For patients intended to receive intravenous thrombolysis, when the blood pressure ranges from 180/100 mmHg to 200/110 mmHg, simultaneous initiation of both intravenous thrombolysis and antihypertensive treatment can be considered. If the blood pressure exceeds 200/110 mmHg, antihypertensive treatment should be initiated first. Intravenous thrombolysis can be commenced after the blood pressure is reduced to below 200/110 mmHg. Before thrombolysis and within 24 hours after the initiation of intravenous thrombolysis, efforts should be made to control the extent of blood pressure reduction. When the blood pressure drops below 180/100 mmHg, antihypertensive treatment should be terminated. Twenty-four hours later, the routine blood pressure management protocol should be reinstated.
PROCEDUREUsual BP management group
To receive blood pressure management according to standard local guidelines. In China, for patients scheduled for intravenous thrombolysis who present with elevated blood pressure, it is advised to maintain blood pressure below 180/100 mmHg for 24 hours, after which standard guideline-based blood pressure management should be resumed.
Sponsors
Shanghai East Hospital
Shanghai 7th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor is independent of the treatment team
Intervention model description
central randomization with stratification
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 to 80 years (inclusive); 2. Patients with acute ischemic stroke; 3. Planned to receive intravenous thrombolysis within 4.5 hours of onset; 4. Elevated blood pressure: Before receiving intravenous thrombolysis treatment, blood pressure is elevated: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg (defined as two consecutive measurements within 2 minutes); 5. Informed consent signed (or signed by a proxy).
Exclusion criteria
1. Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma). 2. History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months. 3. Intracranial tumors, giant intracranial aneurysms. 4. Intracranial or spinal surgery within the last 3 months; major surgery within the last 2 weeks; arterial puncture at a site not easily compressed for hemostasis within the last 7 days. 5. Gastrointestinal or urinary system bleeding within the last 3 weeks. 6. Aortic dissection. 7. Acute bleeding tendency, including platelet count \< 100×10\^9/L or other bleeding tendencies. 8. Received low-molecular-weight heparin orally within 24 hours; taking warfarin with INR \> 1.7 or PT \> 15 seconds; used a new oral anticoagulant within 48 hours. 9. Blood glucose \< 2.8 mmol/L or \> 22.2 mmol/L. 10. Large area cerebral infarction indicated on head CT or MRI (infarction area \> 1/3 of the middle cerebral artery territory). 11. Active visceral hemorrhage, known bleeding diathesis or significant bleeding disorders within the past 6 months 12. Severe ischemic stroke (NIHSS score \> 25) 13. Epileptic seizures at the time of stroke onset 14. Pregnant or lactating women 15. Various terminal diseases with an expected survival of ≤ 3 months 16. Any other physical conditions where the doctor deems participation in this study may be detrimental to the patient 17. Currently participating in other drug or device clinical trials 18. mRS score \> 2 before onset of the disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of symptomatic intracranial hemorrhage | Day 1 | The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of symptomatic intracranial hemorrhage within 24 hours | DAY 1 | The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis (ECASS II criteria, SIST-MOST criteria, NINDS criteria) |
| The proportion of intracranial hemorrhage transformation | Day 1 | The proportion of any intracranial hemorrhage transformation within 24 hours after thrombolysis |
| The proportion of major substantive hemorrhage | The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2) | — |
| The proportion of severe or life-threatening major hemorrhage | DAY 90 | The proportion of severe or life-threatening major bleeding (as defined by GUSTO) |
| time to use of reperfusion treatment | DAY 1 | Door-to-needle time for intravenous thrombolysis patients |
| level of physical function | DAY 90 | 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. |
| death or dependency measured by a shift in mRS | DAY 90 | 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. |
| Death | DAY 90 | — |
| Neurological function measured by NIHSS | day 7 or at discharge | NIHSS score at 7 days or at discharge (if the length of hospital stay is less than 7 days) |
| Neurological function measured by mRS | DAY 7 or at discharge | mRS score at 7 days or at discharge (if the length of hospital stay is less than 7 days) |
| number of patients with serious adverse events | DAY 90 | total number of serious adverse events reported during follow-up, according to standard definitions |
Countries
China
Contacts
CONTACTGang Li
Outcome results
None listed