NCT06880107

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Apr 2025Apr 2027

First Submitted

Initial submission to the registry

March 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 17, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

April 8, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

March 11, 2025

Last Update Submit

January 15, 2026

Conditions

Keywords

annexin A2strokegenetic variantsfibrinolysis

Outcome Measures

Primary Outcomes (2)

  • genetic variants of ANXA2

    day 1

  • genetic variants of S100A10

    day 1

Secondary Outcomes (4)

  • blood ANXA2 concentration

    day 1

  • blood S100A10 concentration

    day 1

  • concentration of Autoantibodies directed against ANXA2

    day 1

  • concentration of S100A10 directed against ANXA2

    day 1

Study Arms (3)

cryptogenic stroke

EXPERIMENTAL

cryptogenic stroke

Biological: blood withdrawal

ischemic stroke

EXPERIMENTAL

ischemic stroke

Biological: blood withdrawal

control subjects

ACTIVE COMPARATOR

control subjects

Biological: blood withdrawal

Interventions

blood withdrawal

control subjectscryptogenic strokeischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Transient ischemic attack
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 17, 2025

Study Start

April 8, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations