Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism

NCT ID: NCT04020666

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 113 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-10-31

Brief Summary

Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired fasting glucose.

Detailed Description

Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort study and divided into two groups. The HUK group were treated with urinary kallidinogenase and standard treatment, the control group received standard treatment. NIHSS scores, mRS scores and fasting blood glucose were evaluated and compared.

Conditions

Acute Ischemic Stroke; Abnormal Glucose Metabolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HUK group

On the basis of routine treatment for cerebral infarction, patients in the HUK group were also given Urinary Kallidinogenase at 0.15 PNA unit/day, for a 10-day course.

Urinary Kallidinogenase

Intervention Type: DRUG

control group

The control group were given routine treatment for cerebral infarction, including anti-platelet aggregation, anticoagulation, lipid-lowering and plaque stabilizing, free radical scavenging, nerve nutrition and brain protection.

No interventions assigned to this group

Interventions

Urinary Kallidinogenase

Intervention Type: DRUG

Other Intervention Names

Kai Li Kang

Eligibility Criteria

Inclusion Criteria

• Aged 18-75 years (male or female)
• Patients were admitted to hospital within 72h of stroke onset
• Diagnosis of acute ischemic stroke according to the criteria stated in the Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China (2010), and patients were confirmed as acute ischemic cerebrovascular disease by head computed tomography (CT) or magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI)
• NIHSS score ranged from 3-21 points
• Patients were previously diagnosed with type 2 diabetes, in which they were in line with the 2006 WHO diagnostic criteria for diabetes, or they had fasting blood glucose of 6.1-6.9mmol/L and glycosylated hemoglobin (HbA1C) of>6.1%
• Patients could cooperate with the test and evaluation of relevant indicators in the trial.

Exclusion Criteria

• Pregnant or lactating women
• Patients with severe heart, liver and kidney dysfunction
• Patients with a history of cerebrovascular disease and who still suffered from serious neurological dysfunction that had an influence on the trial
• Patients with physical disabilities, joint deformities or muscle lesions
• Patients were confirmed with intracranial hemorrhage by CT
• Patients were allergic to the study drug
• Patients suffering from severe systemic infection
• Patients who had participated in other clinical trials within 1 month
• For any reason, the researchers believed that the subject was unlikely to complete the study (such as cerebral infarction caused by cerebral embolism, intracranial arteritis, cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) and moyamoya disease; patients undergoing thrombolysis or thrombectomy after admission; patients and their families were unable to cooperate with follow-up.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaopeng Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Other Identifiers

2016261

Identifier Type: -

Identifier Source: org_study_id