sCLEC-2 in Stroke Study

Acute Ischemic Stroke Clinical Trial

— CLECSTRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05579405
• Other study ID #: CLEC-0001-02
• Secondary ID: CS0011UMIN000048
• Status: Not yet recruiting
• Start date: October 11, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: University of Yamanashi
• Contact: Katsue Suzuki-Inoue, M.D., Ph.D.
• Phone: +81-55-273-9884
• Email: katsuei[@]yamanashi.ac.jp
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
Japan	University of Yamanashi	Chuo-shi	Yamanashi
Japan	Kyushu Medical Center	Fukuoka-shi	Fukuoka
Japan	LSI Medience Co.	Katori	Chiba
Japan	Nippon Medical School Musashikosugi Hospital	Kawasaki-shi	Kanagawa
Japan	Showa General Hospital	Kodaira-shi	Tokyo
Japan	Saiseikai Central Hospital	Minato-ku	Tokyo
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Iwate Medical University	Shiwa-gun	Iwate
Japan	Mie Prefectural General Medical Center	Yokkaichi-shi	Mie

Sponsors (1)

Lead Sponsor	Collaborator
University of Yamanashi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of Acute Ischemic Stroke and TIA	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
Primary	Evaluation of Antithrombotic Therapy	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
Primary	Comparison of sCLEC-2 /D-dimer ratio between cardiogenic and non-cardiogenic etiologies	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
Primary	Correlation of sCLEC-2 levels on admission with outcome of ischemic stroke and TIA at 3 months	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	Correlation of sCLEC-2 levels on admission with severity of ischemic stroke or TIA	(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
Secondary	Difference of sCLEC-2 levels among TOAST subtypes of ischemic stroke	sCLEC-2 levels on admission among subtypes of ischemic stroke will be evaluated.	On admission before treatment