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Intensive Versus Conventional Blood Pressure Control Following Stroke Thrombectomy

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHao Yonggang

About this trial

This clinical trial aims to investigate the safety and efficacy of intensive blood pressure lowering after successful reperfusion with thrombectomy in patients with acute anterior circulation large artery occlusive stroke. The main questions it aims to answer are:

What is the optimal blood pressure range after revascularization with thrombectomy in patients with cerebral embolism? Can intensive blood pressure lowering improve outcomes in cerebral embolism patients following thrombectomy?

Participants will be randomly assigned to either the intervention group, which receives stricter blood pressure control (systolic blood pressure target \<120 mmHg), or the control group, which follows a conventional blood pressure management approach (systolic blood pressure target 140-180 mmHg). Outcomes will be assessed during a 3-month follow-up period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

To receive endovascular thrombectomy <24 hours after the onset of symptoms

Diagnosed with acute anterior circulation ischemic stroke

National Institutes of Health Stroke Scale (NIHSS) score ≤ 30;

Disqualifiers

Pre-existing stroke disability defined by a modified Rankin score (mRS) >2

Unlikely to benefit from or tolerate endovascular thrombectomy, such as severe allergic reaction to contrast agents

Failure to achieve mTICI ≥ 2b with endovascular intervention, or presence of in situ or proximal vascular stenosis

Patients with contraindications for the use of antihypertensive medications, such as allergy to components

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intensive blood pressure management

    Other intervention

    The objective is to achieve a systolic blood pressure (SBP) \<120 mmHg within 1 hour after randomization and maintain this target for 48 hours. Intravenous titration is initiated immediately after randomization, with an SBP of 100 mmHg used as the threshold for discontinuing antihypertensive therapy or initiating vasopressors.

  • Conventional blood pressure management

    Other intervention

    The objective is to maintain an SBP of 140-180 mmHg within 1 hour after randomization and sustain this range for 48 hours. Intravenous antihypertensive agents are administered when SBP exceeds 180 mmHg and discontinued once SBP is ≤150 mmHg.

Treatment groups

910 Participants
are divided into 2 treatment groups
Group A: Intensive blood pressure target groupExperimental treatment 1 intervention
Group B: Standard blood pressure target groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Functional independence at 3 months

A modified Rankin Scale (mRS) score of 0 to 2

Time frame
At 90 days after randomization
2

Symptomatic intracerebral hemorrhage

Defined by the Heidelberg Bleeding Classification criteria

Time frame
At 24±12 hours after randomization
3

All-cause mortality

Time frame
At 90 days after randomization

Secondary outcomes

1

Excellent outcome

A modified Rankin Scale (mRS) score of 0 to 1

Time frame
At 90 days after randomization
2

Serious adverse outcome

A modified Rankin Scale (mRS) score of 5 to 6

Time frame
At 90 days after randomization
3

Shift in scores on the mRS

Time frame
At 90 days after randomization
4

Infarct volume at follow-up CT scan (24±12h)

Time frame
At 24±12 hours after randomization

Other outcomes

Sponsors and contacts

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

Hao Yonggang

Lead sponsor

The Fourth Affiliated Hospital of Soochow University

Sponsor institution

Source ClinicalTrials.gov
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