Health Trials

Efficacy and Safety of the KPCXM18 Injection in Patients With Acute Ischemic Stroke

ConditionAcute Ischemic Stroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorKunming Pharmaceuticals, Inc.

About this trial

This study is a multicenter, randomized, double-blind, parallel, placebo-controlled trial design to evaluate the efficacy and safety of the KPCXM18 injection at different doses for the treatment of acute ischemic stroke.

Eligibility criteria

Qualifiers

1. Age 18 to 80 years old (including 18 years old and 80 years old, based on the date of signing the informed consent form), male or female;

2.Diagnosed with acute ischemic stroke according to the " Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2023 ";

3.During the screening process, it is required that the ischemic stroke should occur within 12 hours after the onset, and it is expected that the investigational drug can be started within 12 hours after the onset; note: The onset time is calculated from the time when the ischemic stroke symptoms appear, If the onset occurs during sleep, the time of onset should be considered as the last time the patient was observed to be normal;

4.Before intravenous thrombolysis, 6 points ≤ NIHSS score ≤ 24 points, and the sum of upper limb and lower limb score ≥2 points;

Disqualifiers

1. Patients with intracranial hemorrhagic diseases confirmed by Imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, subarachnoid hemorrhage, ventricular hemorrhage, Traumatic cerebral hemorrhage, etc;

2. Patients who have received or plan to receive endovascular interventional treatment (including endovascular mechanical thrombectomy, intravascular thrombus aspiration, arterial thrombolysis, angioplasty and stenting) or patients with arteriovenous bridging therapy after this onset;

3. Patients with disturbance of consciousness (NIHSS score Ia>1 point);

4. Patient has a history of intracranial hemorrhage before;

Trial design

Treatments tested in this trial

  • The KPCXM18 injection
  • Placebo
  • The KPCXM18 injection

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Kunming Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov