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Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management

ConditionsStrokeAcute Ischemic StrokeThrombolysis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Adjusted BP management group

    Procedure/Surgery

    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.

  • Usual BP management group

    Procedure/Surgery

    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.

Treatment groups

340 Participants
are divided into 2 treatment groups
Group A: Usual BP management groupOther 1 intervention
Group B: Adjusted BP management groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of symptomatic intracranial hemorrhage

The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis according to ECASS III criteria

Time frame
Day 1

Secondary outcomes

1

The proportion of symptomatic intracranial hemorrhage within 24 hours

The proportion of symptomatic intracranial hemorrhage within 24 hours after thrombolysis (ECASS II criteria, SIST-MOST criteria, NINDS criteria)

Time frame
DAY 1
2

The proportion of intracranial hemorrhage transformation

The proportion of any intracranial hemorrhage transformation within 24 hours after thrombolysis

Time frame
Day 1
3

The proportion of major substantive hemorrhage

Time frame
The proportion of major substantive hemorrhage occurring within 24 hours after thrombolysis (PH2)
4

The proportion of severe or life-threatening major hemorrhage

The proportion of severe or life-threatening major bleeding (as defined by GUSTO)

Time frame
DAY 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai East Hospital

Lead sponsor

Shanghai 7th People's Hospital

Collaborator

Source ClinicalTrials.gov
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