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.

NCT ID: NCT06424548

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2028-12-31

Brief 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. 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.

Conditions

Stroke; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of Sarpogrelate

The intervention group will receive aspirin 100mg plus sarpogrelate 100mg

Group Type: EXPERIMENTAL

Administration of Sarpogrelate

Intervention Type: DRUG

Aspirin 100mg plus Sarpogrelate 100mg

Traditional administration of Clopidogrel

The control group will receive aspirin 100mg plus clopidogrel 75mg

Group Type: OTHER

Traditional administration of Clopidogrel

Intervention Type: DRUG

Aspirin 100mg plus Clopidogrel 75mg

Interventions

Administration of Sarpogrelate

Aspirin 100mg plus Sarpogrelate 100mg

Intervention Type: DRUG

Traditional administration of Clopidogrel

Aspirin 100mg plus Clopidogrel 75mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 19 or over.

2. Neurologically stable patients after 7 days and within 6 months of diagnosis of ischemic stroke.

3. Patients with ankle-brachial index (ABI) <0.9 performed within 6 months of screening, with lower limb vascular stenosis and intermittent claudication.

4. A person who voluntarily agrees to participate in this clinical trial in writing.

Exclusion Criteria

1. Patients who are unable or contraindicated to administer antithrombotic drugs.

2. 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.

3. Patients identified as undergoing renal replacement therapy such as dialysis due to acute or terminal nephropathy during screening.

4. Patients diagnosed with or treated for cancer within 6 months of screening, or identified as having recurrent or metastatic cancer.

5. Patients confirmed to be on medication for liver diseases such as liver cirrhosis during screening.

6. A pregnant and lactating women.

7. Patients with a history of hemorrhagic tendency, conventional cerebral hemorrhage, and gastrointestinal hemorrhage.

8. Patients who need oral anticoagulant therapy instead of antiplatelet drugs for screening.

9. 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.

10. A patient with a loss of consciousness/cognition.

11. Any person who determines that the tester is not suitable for participating in the clinical trial for other reasons.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ewha Womans University Seoul Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tae-Jin Song, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sujin Han

Role: CONTACT

sujinhan1004@gmail.com

820269862635

Other Identifiers

SEUMC 2023-10-009

Identifier Type: -

Identifier Source: org_study_id