Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase

NCT02259738 — Phase 2, Completed, 120 participants, XuanwuH 2

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RegistryNCT02259738
StatusCompleted
PhasePhase 2
Study typeInterventional; na, single group, masking: single, treatment
Enrollment120 (Actual)
SponsorXuanwuH 2 (Other)
ConditionsCerebral Infarction
InterventionsHuman Urinary Kallidinogenase, Shuxuening injection (Drug)
Datesstart 2013-01-01, primary completion 2014-06-01, completion 2014-06-01, first posted 2014-10-08, last updated 2014-10-08
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Cerebral Infarction All trials of Human Urinary Kallidinogenase All trials of Shuxuening injection

-Summary

Human urinary kallidinogenase can promote the establishment of collateral circulation in the ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then increase the perfusion.

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+Detailed description

Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will estimate the cerebral collateral circulation in ischemic regions and final infarct volume, comparing with traditional therapy such as Shuxuening injection, which will provide new evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a method to reflect the infarction center and low perfusion of tissue.

+Arms and interventions

ArmTypeInterventionsDescription
Human urinary kallidinogenase and Shuxuening injectionExperimentalDrug: Human Urinary Kallidinogenase; Drug: Shuxuening injectionHuman urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
  • Human Urinary Kallidinogenase (Drug), also known as youruikelin
  • Shuxuening injection (Drug)

+Outcome measures

Primary outcomes

  • Perfusion Weighted Imaging [7 days]: Reflect the infarction center and low perfusion of tissue

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* Age:greater than or equal to 18 years old and less than or equal to 70 years old;
* Time of onset is less than 7 days;
* Acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery diagnosed by CT or MRI;
* The National Institute of Health Stroke Scale(NIHSS) score is 4 to 20;
* Excluding intracranial hemorrhage using CT or MRI.

Exclusion Criteria:

* The NIHSS score is less than or equal to 3;
* Patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and laceration of brain and other diseases;
* Intracranial hemorrhage displaying by CT or MRI; Cardiac insufficiency;
* Cardiac insufficiency;
* Chronic liver disease(A/G inversion),elevated alanine aminotransferase(ALT)(more than 1.5 times the normal value);
* Increased serum creatinine(more than 1.5 times the normal value);
* Poorly controlled diabetes;
* Recently suffered from hemorrhagic disease or bleeding tendency;
* Recent use of angiotensin-converting enzyme inhibitor (ACEI) drugs;
* Allergic constitution and had a variety of drug allergy history;
* Women in period of pregnancy or lactation.

+Locations (1)

FacilityCityCountryStatus
Department of Neurolgy,Xuanwu Hospital of Capital Medical UniversityBeijing, Beijing MunicipalityChina