sCLEC-2 in Stroke Study (CLECSTRO)

October 10, 2022 updated by: Katsue Suzuki-Inoue M.D. Ph.D., University of Yamanashi

Soluble C-type Lectin-Like Receptor 2 in Stroke Study

Any platelet function tests have not been widely used in the clinical practice of acute cerebrovascular disease because of the concerns in repeatability, economic performance, and simplicity. Soluble C-type lectin-like receptor 2 (sCLEC-2) is a new marker for platelet activation, which can be easily measured by usual blood collection in routine clinical practice. We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA). We planned the sCLEC-2 in Stroke (CLECSTRO), which is a prospective cohort study in patients with acute ischemic stroke (AIS) and transient ischemic attack (TIA).

The purpose of this study is to evaluate the clinical utility of sCLEC-2 as a biomarker for pathophysiology, differential diagnosis, prediction of prognosis, and monitoring of antiplatelet therapy in patients with AIS and TIA. Subjects are patients with AIS or TIA and control patients required for differentiation from AIS or TIA. The target population is 600 including the patients and the controls. The outcomes include difference in plasma sCLEC-2 level between patients with AIS or TIA and patient controls, correlation between sCLEC-2 after antithrombotic therapy and recurrence or worsening of stroke, difference in sCLEC-2/D-dimer ratio between non-cardioembolic and cardioembolic AIS or TIA, and correlation between baseline sCLEC-2 and outcome (modified Rankin scale score) after 3 months. sCLEC-2 could be a widely useful biomarker to contribute to the progress of precision medicine in clinical practice of AIS and TIA.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

The study design is a multicenter prospective cohort study across Japan including 8 stroke centers. Patients are male or female at age of 20 years or older. The inclusion criteria are (1) AIS within 24 hours of onset and mRS 0 to 2, (2) TIA without MRI positivity within 7 days of onset, and (3) contemporary patients with neurological symptoms, who are required for differentiation from AIS or TIA (served as controls). The main exclusion criteria are (1) platelet or coagulation abnormalities, (2) hemorrhagic stroke, head or other trauma, post-surgery, and hemorrhagic tendency, (3) severe infection, (4) inappropriate patients who were judged by doctors, and (5) poor status of blood samples. The target population is 600 in total (AIS 400, TIA 100 and control 100).

The plasma levels of sCLEC-2 are measured with D-dimer, soluble fibrin, and thrombin-antithrombin complex. sCLEC-2 is determined before starting treatment on admission. The modified Rankin Scale (mRS) and NIH Stroke Scale (NIHSS) are evaluated at registration as baseline data. sCLEC-2 as well as mRS and NIHSS are measured at Day 7 or at discharge. mRS is finally evaluated at 3 months. In the controls, plasma levels of sCLEC-2 and the baseline data are collected at entry.

The sCLEC-2 levels are measured for the difference between patients with AIS or TIA and controls, correlation with severity of stroke, correlation with size of infarct, correlation with Age, Blood pressure, Clinical feature, Diabetes, Duration of symptoms (ABCD2) score in TIA, relationship between treatment effect and worsening or recurrence, difference in the sCLEC-2/D-dimer ratio between cardiogenic and non-cardiogenic etiologies, and difference between TOAST subtypes of ischemic stroke. The study protocol has been approved in each ethical committee at stroke centers.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Chiba
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 810-8563
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3694
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 211-8533
        • Nippon Medical School Musashikosugi Hospital
        • Contact:
    • Mie
      • Yokkaichi-shi, Mie, Japan, 510-8561
        • Mie Prefectural General Medical Center
        • Contact:
    • Tokyo
      • Kodaira-shi, Tokyo, Japan, 187-8510
      • Minato-ku, Tokyo, Japan, 108-0073
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
        • Contact:
    • Yamanashi
      • Chuo-shi, Yamanashi, Japan, 409-3898
        • University of Yamanashi
        • Contact:
        • Sub-Investigator:
          • Hiroyuki Kinouchi, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who visit to the department specialized for stroke

Description

Inclusion Criteria:

  1. Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
  2. Transient ischemic attack without MRI positivity within 7 days of onset
  3. Contemporary patients required for differentiation from ischemic stroke or transient ischemic attack

Exclusion Criteria:

  1. Platelet or coagulation abnormalities
  2. Hemorrhagic stroke, head or other trauma, post-surgery, and hemorrhagic tendency
  3. Severe infection
  4. Inappropriate patients who were judged by doctors
  5. Poor status of blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Acute Ischemic Stroke
Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
Transient ischemic attack
Transient ischemic attack without MRI positivity within 7 days of onset
Patient Control
Contemporary patients with neurological symptoms required for differentiation from ischemic stroke or transient ischemic attack

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of Acute Ischemic Stroke and TIA
Time Frame: On admission before treatment
The ischemic stroke group and TIA group will be compared with the control group to evaluate whether the sCLEC-2 level contributes to the improvement of the diagnostic accuracy of ischemic stroke and TIA.
On admission before treatment
Evaluation of Antithrombotic Therapy
Time Frame: On 7+/-1 days after admission
The post-treatment sCLEC-2 levels in patients with acute ischemic cerebrovascular disorders will be compared between patients without worsening/recurrence (effective treatment group) and those with worsening/recurrence during treatment (ineffective treatment group) to evaluate whether sCLEC-2 measurements contribute to the evaluation of the efficacy of antithrombotic therapy.
On 7+/-1 days after admission
Comparison of sCLEC-2 /D-dimer ratio between cardiogenic and non-cardiogenic etiologies
Time Frame: On admission before treatment
The ischemic stroke group and TIA group will be classified into cardiogenic and non-cardiogenic etiologies based on the TOAST classification to evaluate whether the sCLEC-2/ D-dimer ratio contributes to the accuracy of subtype classification.
On admission before treatment
Correlation of sCLEC-2 levels on admission with outcome of ischemic stroke and TIA at 3 months
Time Frame: On admission before treatment and 3 months after onset
The relationships between the sCLEC-2 levels on admission and outcomes at 3 months in the ischemic stroke and TIA groups will be evaluated.
On admission before treatment and 3 months after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of sCLEC-2 levels on admission with severity of ischemic stroke or TIA
Time Frame: On admission before treatment
(1) Correlation with ischemic stroke severity (NIHSS), (2) correlation with size of infarct, (3) correlation with ABCD2 score in TIA will be evaluated.
On admission before treatment
Difference of sCLEC-2 levels among TOAST subtypes of ischemic stroke
Time Frame: On admission before treatment
sCLEC-2 levels on admission among subtypes of ischemic stroke will be evaluated.
On admission before treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yamanashi

Investigators

  • Principal Investigator: Katsue Suzuki-Inoue, M.D., Ph.D., University of Yamanashi
  • Study Chair: Shinichiro Uchiyama, M.D., Sanno Medical Center/LSI Medience Co.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 11, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 10, 2022

First Submitted That Met QC Criteria

October 10, 2022

First Posted (Actual)

October 13, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEC-0001-02
  • CS0011 (Other Identifier: University of Yamanashi)
  • UMIN000048954 (Other Identifier: UMIN-CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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