Cerebral InfarctionPhase 2NCT02259738
Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
A Phase 2 study testing Human Urinary Kallidinogenase and Shuxuening injection in people with Cerebral Infarction, run by XuanwuH 2 at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Human Urinary Kallidinogenase and Shuxuening injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jan 2013to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurolgy,Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, 100053
About this study
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.
Read the 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.
- Conditions
- Cerebral Infarction
- Being tested
- Human Urinary Kallidinogenase, Shuxuening injection
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Urinary KallidinogenaseDrug
Also called youruikelin
Shuxuening injectionDrug
| Study group | Role | What they receive |
|---|---|---|
| Human urinary kallidinogenase and Shuxuening injection | Experimental | Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days. Receives: Drug: Human Urinary Kallidinogenase; Drug: Shuxuening injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion Weighted Imaging
Reflect the infarction center and low perfusion of tissue
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- XuanwuH 2
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XuanwuH 2, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259738
- Sponsor's protocol ID
- hanying1
- Status last verified
- Oct 2014
- First submitted
- 16 Sep 2014
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase
- ClinicalTrials.gov ID
- NCT02259738
- Acronym / sponsor ID
- hanying1
- Conditions
- Cerebral Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- XuanwuH 2University, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human urinary kallidinogenase and Shuxuening injection | Experimental | Drug: Human Urinary Kallidinogenase, Drug: Shuxuening injectionHuman urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Urinary KallidinogenaseAlso: youruikelin | Drug | Human urinary kallidinogenase and Shuxuening injection |
| Shuxuening injection | Drug | Human urinary kallidinogenase and Shuxuening injection |
Primary outcome
Perfusion Weighted Imaging
Time frame: 7 days
Reflect the infarction center and low perfusion of tissue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Urinary Kallidinogenase and Shuxuening injection in people with Cerebral Infarction, run by XuanwuH 2 at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfusion Weighted Imaging (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2014.