- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06880107
Genetic Variants of Annexin A2 and Cryptogenic Stroke (GENANXVA)
Stroke is the third most common cause of death in developed countries. Various mechanisms of ischemic stroke exist. However, in young population, in a third of cases, the cause of a stroke cannot be determined despite an extensive evaluation. Many studies have highlighted the link between stroke and fibrinolysis. Genetic variants of tPA and PAI-1 genes have been suggested to be the risk factors for stroke.
ANXA2 plays a pivotal role in plasmin generation and fibrinolysis. Several studies showed the role of ANXA2 and S100A10 subunits in regulation of fibrinolysis in vivo. Recently, the efficacy of recombinant ANXA2 for fibrinolytic therapy in a rat embolic stroke has been demonstrated. Some single nucleotide polymorphisms in ANXA2 gene could be associated with increased risk of stroke in sickle cell disease.
Therefore, these data invite us to test hypothesis that genetic variants of ANXA2 gene could be associated with ischemic stroke.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valéry Salle, MD
- Phone Number: 33+3 22 66 82 30
- Email: salle.valery@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHRU Amiens
-
Sub-Investigator:
- Olivier GODEFROY, Pr
-
Contact:
- Valéry Salle, MD
- Phone Number: 33+3 22 66 82 30
- Email: salle.valery@chu-amiens.fr
-
Sub-Investigator:
- Sandrine CANAPLE, MD
-
Sub-Investigator:
- Chantal LAMY, MD
-
Sub-Investigator:
- Audrey ARNOUX COURSELLE, MD
-
Sub-Investigator:
- Estelle CADET, rPH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Completed ischemic stroke defined as a rapidly developing focal neurologic deficit with no apparent cause other than a vascular origin that persisted beyond 24 hours in surviving patients
- Age from 18 years old
Exclusion Criteria:
- Transient ischemic attack
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: cryptogenic stroke
|
blood withdrawal
|
|
Experimental: ischemic stroke
|
blood withdrawal
|
|
Active Comparator: control subjects
|
blood withdrawal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
genetic variants of ANXA2
Time Frame: day 1
|
day 1
|
|
genetic variants of S100A10
Time Frame: day 1
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
blood ANXA2 concentration
Time Frame: day 1
|
day 1
|
|
blood S100A10 concentration
Time Frame: day 1
|
day 1
|
|
concentration of Autoantibodies directed against ANXA2
Time Frame: day 1
|
day 1
|
|
concentration of S100A10 directed against ANXA2
Time Frame: day 1
|
day 1
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2023_843_0150
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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