Acute Ischemic StrokeCLECSTRONCT05579405
sCLEC-2 in Stroke Study
An observational study of Acute Ischemic Stroke and Transient Ischemic Attack, run by University of Yamanashi at 9 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Transient Ischemic Attack
- How many people
- 600 participants
- Where
- 9 sitesJapan
- Study dates
- 11 Oct 2022to 31 Dec 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit to the department specialized for stroke
Who may be able to join
- Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
- Transient ischemic attack without MRI positivity within 7 days of onset
- Contemporary patients required for differentiation from ischemic stroke or transient ischemic attack
Who cannot join
- Platelet or coagulation abnormalities
- Hemorrhagic stroke, head or other trauma, post-surgery, and hemorrhagic tendency
- Severe infection
- Inappropriate patients who were judged by doctors
- Poor status of blood samples
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
University of Yamanashi
Chuo-shi, Yamanashi, 409-3898
Katsue Suzuki-Inoue, M.D., Ph.D., +81-55-273-9884, katsuei@yamanashi.ac.jp
Hiroyuki Kinouchi, M.D.
Kyushu Medical Center
Fukuoka, Fukuoka, 810-8563
Hiroshi Sugimori, M.D., +81-92-852-0700, sugimori.hiroshi.zb@mail.hosp.go.jp
Yasushi Okada, M.D.
LSI Medience Co.
Katori-shi, Chiba, 289-2247
Ayako Nishimura, +81-479-76-3672, nishimura.ayako@mx.medience.co.jp
Masahide Kawamura, M.Sc., +81-3-5577-0608, kawamura.masahide@mv.medience.co.jp
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, 211-8533
Takehiko Nagao, M.D., +81-44-733-5181, longtail@nms.ac.jp
Showa General Hospital
Kodaira-shi, Tokyo, 187-8510
Yutaka Honma, M.D., +81-42-461-0052, honma.yutaka@showa-hp.jp
Saiseikai Central Hospital
Minato-ku, Tokyo, 108-0073
Haruhiko Hoshino, M.D., +81-3-3451-8211, hhoshino@grape.plala.or.jp
Koichi Oki, M.D., +81-3-3451-8211, koki.z8@keio.jp
Kyorin University Hospital
Mitaka-shi, Tokyo, 181-8611
Teruyuki Hirano, M.D., +81-422-47-5511, terry@ks.kyorin-u.ac.jp
Iwate Medical University
Shiwa-gun, Iwate, 028-3694
Ryo Itabashi, M.D., +81-19-651-5111, ritabash@iwate-med.ac.jp
Mie Prefectural General Medical Center
Yokkaichi-shi, Mie-ken, 510-8561
Nobuo Ito, M.D., +81-59-345-2321, nobuo-itou@mie-gmc.jp
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Platelet Activation, Soluble C-Type Lectin-Like Receptor 2
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On admission before treatment
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.
Measured: On 7+/-1 days after admission
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.
Measured: On admission before treatment
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.
Measured: On admission before treatment and 3 months after onset
Secondary outcomes (2)
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.
Measured: On admission before treatment
Difference of sCLEC-2 levels among TOAST subtypes of ischemic stroke
sCLEC-2 levels on admission among subtypes of ischemic stroke will be evaluated.
Measured: On admission before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start11 Oct 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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 Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yamanashi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katsue Suzuki-Inoue M.D. Ph.D., University of Yamanashi
- Investigators
- Katsue Suzuki-Inoue, M.D., Ph.D., Principal investigator, University of YamanashiShinichiro Uchiyama, M.D., Study chair, Sanno Medical Center/LSI Medience Co.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579405
- Sponsor's protocol ID
- CLEC-0001-02
- Other IDs
- CS0011, UMIN000048954
- Acronym
- CLECSTRO
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Uchiyama S, Suzuki-Inoue K, Wada H, Okada Y, Hirano T, Nagao T, Kinouchi H, Itabashi R, Hoshino H, Oki K, Honma Y, Ito N, Sugimori H, Kawamura M. Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack. BMJ Open. 2023 Sep 18;13(9):e073708. doi: 10.1136/bmjopen-2023-073708.
PubMed 37723115
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soluble C-type Lectin-Like Receptor 2 in Stroke Study
- ClinicalTrials.gov ID
- NCT05579405
- Acronym / sponsor ID
- CLECSTRO / CLEC-0001-02
- Conditions
- Acute Ischemic Stroke, Transient Ischemic Attack
- Keywords
- Platelet Activation, Soluble C-Type Lectin-Like Receptor 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of YamanashiUniversity, hospital or other
- Study start
- 11 Oct 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who visit to the department specialized for stroke
Key inclusion criteria (3 listed)
- Ischemic stroke within 24 hours of onset and modified Rankin Scale 0 to 2
- Transient ischemic attack without MRI positivity within 7 days of onset
- Contemporary patients required for differentiation from ischemic stroke or transient ischemic attack
Key exclusion criteria (5 listed)
- Platelet or coagulation abnormalities
- Hemorrhagic stroke, head or other trauma, post-surgery, and hemorrhagic tendency
- Severe infection
- Inappropriate patients who were judged by doctors
- Poor status of blood samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Correlation of sCLEC-2 levels on admission with severity of ischemic stroke or TIA
Time frame: On admission before treatment
Difference of sCLEC-2 levels among TOAST subtypes of ischemic stroke
Time frame: On admission before treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 37723115Uchiyama S, Suzuki-Inoue K, Wada H, Okada Y, Hirano T, Nagao T, Kinouchi H, Itabashi R, Hoshino H, Oki K, Honma Y, Ito N, Sugimori H, Kawamura M. Soluble C-type lectin-like receptor 2 in stroke (CLECSTRO) study: protocol of a multicentre, prospective cohort of a novel platelet activation marker in acute ischaemic stroke and transient ischaemic attack. BMJ Open. 2023 Sep 18;13(9):e073708. doi: 10.1136/bmjopen-2023-073708.
- Individual participant dataSharing planned: Yes
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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.
Katsue Suzuki-Inoue, M.D., Ph.D. principal investigator
University of Yamanashi
Shinichiro Uchiyama, M.D. study chair
Sanno Medical Center/LSI Medience Co.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Transient Ischemic Attack, run by University of Yamanashi at 9 sites in Japan.
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 3 inclusion and 5 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 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Japan. 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 Katsue Suzuki-Inoue, M.D., Ph.D. (+81-55-273-9884, katsuei@yamanashi.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of Acute Ischemic Stroke and TIA (time frame: On admission before treatment). The study lists 4 primary outcomes in all. 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 NCT05579405, 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 13 Oct 2022.