Effects of Urinary Kallidinogenase in Acute Ischemic Stro... | NCT04020666

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

NCT04020666

Sponsor

The Second Hospital of Hebei Medical University

Status

Completed

Last Update Posted

Jul 16, 2019Actual

Enrollment

113Actual

Phase

Not provided

Conditions

Acute Ischemic Stroke
Abnormal Glucose Metabolism

Interventions

Urinary Kallidinogenase

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Jul 2, 2019

First Submission Date that Met QC Criteria

Jul 15, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2019

Last Update Posted Date

Jul 16, 2019Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Drug: Urinary Kallidinogenase
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Urinary Kallidinogenase	Drug		HUK group	Kai Li Kang

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
NIHSS Score at 90 Days	Comparison of NIHSS score between the control and HUK group at 90 days	at 90 days after admission

Secondary Outcomes

Measure	Description	Time Frame
NIHSS Score at 10 Days、30 Days	Comparison of NIHSS score between the control and HUK group at 10days、30days.	at 10 days, 30 days after admission
Factors related to Non-General Recovery (90-day NIHSS was reduced by <90%)

Other Outcomes

Not provided

Eligibility Module

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study and divided into two groups.

Sampling Method

Non-Probability Sample

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases