Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
Recruiting
Phase 2Interventional Study
StrokeAcute Ischemic StrokeThrombolysis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
340 (estimated)
Sponsor
Shanghai East Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility Criteria
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 pressu…
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.
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