Ischemic StrokeNCT03733223
Relationships Among FVIII, t-PA/PAI-1, and MMP-9 Levels and Intracranial Hemorrhage Complications After Thrombolysis With Alteplase in Patients With Acute Ischemic Stroke: Protocol for a Multicenter Retrospective Study
An observational study of Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial summary
The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ateptidase
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2018to Dec 2020
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischemic stroke treated with Alteplase
Who may be able to join
- Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
- 18 y age 85 y•
- Symptoms of neurological deficits caused by cerebral infarction
- Informed consent form to confirm thrombolytic therapy have signed by patients or their family.
Who cannot join
- A history of major head trauma or stroke in the past 3 months
- Suspicious subarachnoid hemorrhage
- Arterial puncture at noncompressible site in the last week
- History of intracranial hemorrhage
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
- Recent intracranial or intraspinal surgery
Show all 23Show fewer
- Elevated blood pressure (systolic >185 mm Hg or diastolic >110 mm Hg)
- Active internal bleeding or Acute bleeding diathesis
- Platelet count <100×109·L-1
- Heparin received within 48 h resulting in aPTT above the upper limit of normal
- Current use of anticoagulant with INR >1.7 or PT >15 s
- Current use of thrombin inhibitors or factor Xa inhibitors
- Abnormal laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
- Blood glucose concentration > 2.7 mmol/L
- CT demonstrates multilobar infarction (hypodensity >1/3 cerebral hemisphere)
- Mild cerebral infarction or rapid improvement of symptoms of cerebral infarction
- Symptoms of neurological impairment after seizures
- Major surgery or severe trauma in the past 2 weeks
- Gastrointestinal or urinary bleeding in the past 3 weeks
- History of myocardial infarction in the past 3 months
- Combine diseases that may affect outcomes,such as Anemia, hemophilia
- History of autoimmune disease or organ transplantation
- Pregnancy or breastfeeding women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280
Shuai He, Doctor, 8618520041983, hs43555@qq.com
Yanjaio Ma, Master, 8618819132903, 18819132903@163.com
About this study
The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.
Read the detailed description
Patients with acute ischemic stroke treated with alteplase within 4.5 hours after the onset of stroke symptoms will be recruited in this study. All participants will be divided into two groups according to whether intracranial hemorrhage occurred within 3 days after treatment with alteplase for analysis. Differences in FVIII, t-PA/PAI-1, and MMP-9 levels before and after thrombolytic therapy will be examined in both groups. This study will be conducted at Zhujiang Hospital of Southern Medical University, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Jinan University.
- Conditions
- Ischemic Stroke
- Being tested
- Ateptidase
- Keywords
- t-PA/PAI-1, MMP-9, FVIII, Alteplase, intracranial haemorrhage, Ischemic stroke
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AteptidaseDrug
Treatment of ischemic stroke with Ateptidase
| Study group | Role | What they receive |
|---|---|---|
| experimental group | The patients who were treated with Ateptidase had intracranial haemorrhage adverse reactions Receives: Drug: Ateptidase | |
| control group | The patients who were treated with Ateptidase did not have intracranial haemorrhage adverse reactions. Receives: Drug: Ateptidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial hemorrhage
The occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start12 Oct 2018
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University
- Responsible party
- Sponsor
- Investigators
- Shuai He, Doctor, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733223
- Sponsor's protocol ID
- 2018-YXB-002
- Status last verified
- Mar 2019
- First submitted
- 5 Nov 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Liao X, Zhao X, Wang DZ, Wang C, Nguyen-Huynh MN, Zhou Y, Liu L, Wang X, Liu G, Li H, Wang Y; China National Stroke Registry Investigators. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011 Jun;42(6):1658-64. doi: 10.1161/STROKEAHA.110.604249. Epub 2011 Apr 21.
PubMed 21512182
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships Among FVIII, t-PA/PAI-1, and MMP-9 Levels and Intracranial Hemorrhage Complications After Thrombolysis With Alteplase in Patients With Acute Ischemic Stroke: Protocol for a Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT03733223
- Acronym / sponsor ID
- 2018-YXB-002
- Conditions
- Ischemic Stroke
- Keywords
- t-PA/PAI-1, MMP-9, FVIII, Alteplase, intracranial haemorrhage, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Nov 2018 (actual)
- 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.
The primary aim of the study is to investigate the relationships among FVIII, t-PA/PAI-1, MMP-9 levels, and intracranial hemorrhage after thrombolysis with alteplase using a combined analysis.
Detailed description
Patients with acute ischemic stroke treated with alteplase within 4.5 hours after the onset of stroke symptoms will be recruited in this study. All participants will be divided into two groups according to whether intracranial hemorrhage occurred within 3 days after treatment with alteplase for analysis. Differences in FVIII, t-PA/PAI-1, and MMP-9 levels before and after thrombolytic therapy will be examined in both groups. This study will be conducted at Zhujiang Hospital of Southern Medical University, Nanfang Hospital of Southern Medical University, and the First Affiliated Hospital of Jinan University.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Drug: AteptidaseThe patients who were treated with Ateptidase had intracranial haemorrhage adverse reactions |
| control group | – | Drug: AteptidaseThe patients who were treated with Ateptidase did not have intracranial haemorrhage adverse reactions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke treated with Alteplase
Key inclusion criteria (4 listed)
- Diagnosis of ischemic stroke and within the time window of thrombolysis (Onset of symptoms no more than 4.5 hours )
- 18 y age 85 y•
- Symptoms of neurological deficits caused by cerebral infarction
- Informed consent form to confirm thrombolytic therapy have signed by patients or their family.
Key exclusion criteria (23 listed)
- A history of major head trauma or stroke in the past 3 months
- Suspicious subarachnoid hemorrhage
- Arterial puncture at noncompressible site in the last week
- History of intracranial hemorrhage
- Intracranial neoplasm, arteriovenous malformation, or aneurysm
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 |
|---|---|---|
| AteptidaseTreatment of ischemic stroke with Ateptidase | Drug | control group, experimental group |
Primary outcome
Intracranial hemorrhage
Time frame: 3 days
The occurrence of intracranial haemorrhage adverse reactions in ischemic stroke patients receiving thrombolytic therapy by alteplase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Results publication: PubMed 21512182Wang Y, Liao X, Zhao X, Wang DZ, Wang C, Nguyen-Huynh MN, Zhou Y, Liu L, Wang X, Liu G, Li H, Wang Y; China National Stroke Registry Investigators. Using recombinant tissue plasminogen activator to treat acute ischemic stroke in China: analysis of the results from the Chinese National Stroke Registry (CNSR). Stroke. 2011 Jun;42(6):1658-64. doi: 10.1161/STROKEAHA.110.604249. Epub 2011 Apr 21.
- Individual participant dataSharing planned: No
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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.
Shuai He, Doctor principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Zhujiang Hospital 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 4 inclusion and 23 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuai He, Doctor (862062783372, hs43555@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial hemorrhage (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733223, which also lists 1 linked publication.
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 19 Mar 2019.