Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai East Hospital
About this trial
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).
Eligibility criteria
Qualifiers
Age 18 to 80 years (inclusive);
Patients with acute ischemic stroke;
Planned to receive intravenous thrombolysis within 4.5 hours of onset;
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);
Disqualifiers
Intracranial hemorrhage is indicated on CT or MRI (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma).
History of intracranial hemorrhage; severe head trauma or stroke within the last 3 months.
Intracranial tumors, giant intracranial aneurysms.
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.
Trial design
Treatments tested in this trial
- Adjusted BP management group
- Usual BP management group
Treatment groups
340 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai East Hospital
Lead sponsor
Shanghai 7th People's Hospital
Collaborator
Source ClinicalTrials.gov