StrokeNCT06424548
Comparison of the Improvement and Safety of the Ankle Brachial Arterial Pressure Index of Sarpogrelate and Clopidogrel in Stroke Patients With Decreased Ankle Brachial Arterial Pressure Index and Intermittent Claudication of Lower Limb Vascular Atherosclerosis.
A study testing Administration of Sarpogrelate and Traditional administration of Clopidogrel in people with Stroke and Atherosclerosis, run by Ewha Womans University Seoul Hospital.
Trial summary
The clinical trial aims to confirm the improvement effect of the ankle brachial index and the safety of sarpogrelate administration compared to clopidogrel in stroke patients with decreased ankle brachial arterial pressure index and intermittent claudication of lower limb vascular atherosclerosis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke, Atherosclerosis
- What is being tested?
- Administration of Sarpogrelate and Traditional administration of Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19 or over.
- Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke.
- Patients with ankle-brachial index (ABI) <0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication.
- A person who voluntarily agrees to participate in this clinical trial in writing.
Who cannot join
- Patients who are unable or contraindicated to administer antithrombotic drugs.
- Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels and total bilirubin levels three times normal according to laboratory standards, according to blood tests conducted within one month.
- Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.
- Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer.
- Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening.
- A pregnant and lactating women.
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- Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage.
- Patients who need oral anticoagulant therapy instead of antiplatelet drugs for screening.
- Patients who are at least 3 in the Rutherford category and need lower-limb vascular procedure/surgery within 6 months, as judged by the doctor.
- A patient with a loss of consciousness/cognition.
- Any person who determines that the tester is not suitable for participating in the clinical trial for other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Investigator-initiated, Pilot Clinical Trial Comparing the Improvement for Ankle Brachial Index and Safety of Sarpogrelate and Clopidogrel in Stroke Patients Accompanying Lower Extremity Vascular Atherosclerosis With Decrease of Ankle Brachial Index and Intermittent Claudication.
The clinical trial aims to confirm the improvement effect of the ankle brachial index and the safety of sarpogrelate administration compared to clopidogrel in stroke patients with decreased ankle brachial arterial pressure index and intermittent claudication of lower limb vascular atherosclerosis. Subjects are assigned to one of the two combinations through random allocation.
Intervention group: Aspirin 100mg + sarpogrelate 300mg dosing group, Control group: Aspirin 100mg + clopidogrel 75mg dosing group. This clinical trial is a prospective open study and will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all trial subjects will be tested and treated appropriately in accordance with the standard treatment guidelines for ischemic stroke during the clinical trial period.
Read the detailed description
A total of 100 subjects are recruited and divided into a intervention group and a control group through randomization.
In this clinical trial, the intervention group and the control group are assigned 1:1.
The researcher allocates 1:1 to the intervention group or control group through a two-way random number table on the assignment date in the order of the subjects who are satisfied with the Inclusion and exclusion criteria and agreed to the study.
This study is a prospective open randomized clinical trial that can confirm which group the subjects themselves were assigned to. After randomization, the drug is prescribed and the outcome variable is checked at 12 months.
During the course of the clinical trial, the examiner and researchers carefully observe the presence or absence of adverse events during the follow-up period after randomization, and closely observe outcome variables, including neurological changes.
Visit after 6 months and 12 months during the clinical trial period to confirm the effectiveness and safety. When an event corresponding to the outcome variable occurs, the researcher first plans to implement appropriate medical measures in this regard.
Both groups will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all subjects will be tested and treated appropriately according to the standard treatment guidelines for ischemic stroke during the clinical trial period.
The purpose of this study is to determine whether there is a difference in the improvement and safety of the ankle-brachial arterial pressure index of aspirin+sarpogrelate and aspirin+clopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication.
- Conditions
- Stroke, Atherosclerosis
- Being tested
- Administration of Sarpogrelate, Traditional administration of Clopidogrel
- Medical subject headings
- Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of SarpogrelateDrug
Aspirin 100mg plus Sarpogrelate 100mg
Traditional administration of ClopidogrelDrug
Aspirin 100mg plus Clopidogrel 75mg
| Study group | Role | What they receive |
|---|---|---|
| Administration of Sarpogrelate | Experimental | The intervention group will receive aspirin 100mg plus sarpogrelate 100mg Receives: Drug: Administration of Sarpogrelate |
| Traditional administration of Clopidogrel | Other | The control group will receive aspirin 100mg plus clopidogrel 75mg Receives: Drug: Traditional administration of Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle brachial index
The value of the ankle brachial index evaluated 12 months after the first dose of the clinical trial drug. Ankle brachial index : normal range > 0.9, abnormal range < 0.9
Measured: Baseline, 12months
Secondary outcomes (9)
Ankle brachial index
The value of the ankle brachial index evaluated 6 months after the first dose of the clinical trial drug. Ankle brachial index : normal range > 0.9, abnormal range < 0.9
Measured: Baseline, 6months
Brachial ankle pulse wave velocity
The value of Brachial ankle pulse wave velocity evaluated 6 months and 12months after the first dose of the clinical trial drug. Brachial ankle pulse wave velocity : normal range 1000~1500 cm/sec, abnormal range > 1600 cm/sec
Measured: Baseline, 6months, 12months
Major cardio-cerebrovascular events
Major cardio-cerebrovascular events that occurred within 6 months and 12 months after the first medication related to the clinical trial. (Stroke, myocardial infarction, non-stable angina, lower limb vascular intervention, surgery, death)
Measured: Baseline, 6months, 12months
Lower limb angioplasty or re-operation
Whether or not to perform lower limb angioplasty or re-operation, evaluated 6 months and 12 months after the first dose of the clinical trial drug.
Measured: Baseline, 6months, 12months
Change of Rutherford category ratio
Change of Rutherford category ratio, a symptom scale related to vascular stenosis of the lower extremities, evaluated 6 months and 12 months after the first dose of the clinical trial drug. (Grade 0-Asymptomatic, Grade 1-Mild claudication, Grade 2-Moderate claudication, Grade 3-Severe claudication, Grade 4-Ischemic rest pain, Grade 5-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia, Grade 6-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable)
Measured: Baseline, 6months, 12months
Modified Rankin scale
Modified Rankin scale evaluated 6 months and 12 months after the first dose of the clinical trial drug. (0-No symptoms at all, 1-No significant disability despite symptoms; able to carry out all usual duties and activities, 2-Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, 3-Moderate disability; requiring some help, but able to walk without assistance, 4-Moderate to severe disability; unable to walk without assistance, and unable to attend to own bodily needs without assistance, 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention, 6-Death)
Measured: Baseline, 6months, 12months
National Institutes of Health Stroke Scale
Changes in NIHSS evaluated at 6 months and 12 months after the first dose of the clinical trial drug. National Institutes of Health Stroke Scale score of 0 (lowest point) means normal, and a score of 42 (high point) means severe dysfunction caused by stroke, so the higher the score, the more severe the stroke.
Measured: Baseline, 6months, 12months
Coronary angioplasty
Confirmation that coronary angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
Measured: Baseline, 6months, 12months
Cerebrovascular angioplasty
Confirmation that cerebrovascular angioplasty was performed at 6 months and 12 months after the first dose of the drug in the clinical trial.
Measured: Baseline, 6months, 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start16 May 2024 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Jin Song, MD, PhD, Ewha Womans University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424548
- Sponsor's protocol ID
- SEUMC 2023-10-009
- Status last verified
- May 2024
- First submitted
- 15 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Investigator-initiated, Pilot Clinical Trial Comparing the Improvement for Ankle Brachial Index and Safety of Sarpogrelate and Clopidogrel in Stroke Patients Accompanying Lower Extremity Vascular Atherosclerosis With Decrease of Ankle Brachial Index and Intermittent Claudication.
- ClinicalTrials.gov ID
- NCT06424548
- Acronym / sponsor ID
- SEUMC 2023-10-009
- Conditions
- Stroke, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ewha Womans University Seoul HospitalUniversity, hospital or other
- Study start
- 16 May 2024 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 May 2024 (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.
The clinical trial aims to confirm the improvement effect of the ankle brachial index and the safety of sarpogrelate administration compared to clopidogrel in stroke patients with decreased ankle brachial arterial pressure index and intermittent claudication of lower limb vascular atherosclerosis. Subjects are assigned to one of the two combinations through random allocation.
Intervention group: Aspirin 100mg + sarpogrelate 300mg dosing group, Control group: Aspirin 100mg + clopidogrel 75mg dosing group. This clinical trial is a prospective open study and will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all trial subjects will be tested and treated appropriately in accordance with the standard treatment guidelines for ischemic stroke during the clinical trial period.
Detailed description
A total of 100 subjects are recruited and divided into a intervention group and a control group through randomization.
In this clinical trial, the intervention group and the control group are assigned 1:1.
The researcher allocates 1:1 to the intervention group or control group through a two-way random number table on the assignment date in the order of the subjects who are satisfied with the Inclusion and exclusion criteria and agreed to the study.
This study is a prospective open randomized clinical trial that can confirm which group the subjects themselves were assigned to. After randomization, the drug is prescribed and the outcome variable is checked at 12 months.
During the course of the clinical trial, the examiner and researchers carefully observe the presence or absence of adverse events during the follow-up period after randomization, and closely observe outcome variables, including neurological changes.
Visit after 6 months and 12 months during the clinical trial period to confirm the effectiveness and safety. When an event corresponding to the outcome variable occurs, the researcher first plans to implement appropriate medical measures in this regard.
Both groups will be conducted in compliance with the usual diagnosis and treatment process, and in particular, all subjects will be tested and treated appropriately according to the standard treatment guidelines for ischemic stroke during the clinical trial period.
The purpose of this study is to determine whether there is a difference in the improvement and safety of the ankle-brachial arterial pressure index of aspirin+sarpogrelate and aspirin+clopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Administration of Sarpogrelate | Experimental | Drug: Administration of SarpogrelateThe intervention group will receive aspirin 100mg plus sarpogrelate 100mg |
| Traditional administration of Clopidogrel | Other | Drug: Traditional administration of ClopidogrelThe control group will receive aspirin 100mg plus clopidogrel 75mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 19 or over.
- Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke.
- Patients with ankle-brachial index (ABI) <0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication.
- A person who voluntarily agrees to participate in this clinical trial in writing.
Key exclusion criteria (11 listed)
- Patients who are unable or contraindicated to administer antithrombotic drugs.
- Patients with less than 80,000 platelets, less than 8.0 hemoglobin, liver levels and total bilirubin levels three times normal according to laboratory standards, according to blood tests conducted within one month.
- Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.
- Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer.
- Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of SarpogrelateAspirin 100mg plus Sarpogrelate 100mg | Drug | Administration of Sarpogrelate |
| Traditional administration of ClopidogrelAspirin 100mg plus Clopidogrel 75mg | Drug | Traditional administration of Clopidogrel |
Primary outcome
Ankle brachial index
Time frame: Baseline, 12months
The value of the ankle brachial index evaluated 12 months after the first dose of the clinical trial drug. Ankle brachial index : normal range > 0.9, abnormal range < 0.9
9 secondary outcomes
Ankle brachial index
Time frame: Baseline, 6months
Brachial ankle pulse wave velocity
Time frame: Baseline, 6months, 12months
Major cardio-cerebrovascular events
Time frame: Baseline, 6months, 12months
Lower limb angioplasty or re-operation
Time frame: Baseline, 6months, 12months
Change of Rutherford category ratio
Time frame: Baseline, 6months, 12months
Modified Rankin scale
Time frame: Baseline, 6months, 12months
National Institutes of Health Stroke Scale
Time frame: Baseline, 6months, 12months
Coronary angioplasty
Time frame: Baseline, 6months, 12months
Cerebrovascular angioplasty
Time frame: Baseline, 6months, 12months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of Sarpogrelate and Traditional administration of Clopidogrel in people with Stroke and Atherosclerosis, run by Ewha Womans University Seoul Hospital.
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 4 inclusion and 11 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: opening soon, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sujin Han (820269862635, sujinhan1004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ankle brachial index (time frame: Baseline, 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2024.