Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYi Yang

About this trial

The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years old;

Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;

Moderate to severe stenosis or occlusion of offending vessels;

The mRS Score ≤2 before onset;

Disqualifiers

Transient ischemic attack;

Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);

Severe disturbance of consciousness:GCS ≤8;

Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Urinary kallidinogenase for injection

    Drug

    Urinary kallidinogenase 0.15PNA once daily for 7 days.

  • Guideline-prescribed medical therapy

    Other intervention

    Guideline-prescribed medical therapy

Treatment groups

986 Participants
are divided into 2 treatment groups
Group A: Urinary Kallidinogenase groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days

Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.

Time frame
90 days

Secondary outcomes

1

National Institute of Health Stroke Scale (NIHSS) at 7days.

National Institute of Health stroke Scale (NIHSS) ranged from 0 to 42, a low value represents a better outcome.

Time frame
7days
2

Incidence of ischemic stroke within 90 days.

Including recurrent and new ischemic stroke.

Time frame
0-90days
3

Adverse events occurring in the course of the treatment.

Including all adverse events, severe adverse events and urinary kallidinogenase related adverse events.

Time frame
0-7days

Other outcomes

Sponsors and contacts

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

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: