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.

NCT06424548 | Not Yet Recruiting

• 1 other identifier: SEUMC 2023-10-009
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 12months

Secondary Outcomes (9)

• Ankle brachial index

  Baseline, 6months

• Brachial ankle pulse wave velocity

  Baseline, 6months, 12months

• Major cardio-cerebrovascular events

  Baseline, 6months, 12months

• Lower limb angioplasty or re-operation

  Baseline, 6months, 12months

• Change of Rutherford category ratio

  Baseline, 6months, 12months

Study Arms (2)

Administration of Sarpogrelate

EXPERIMENTAL

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

Drug: Administration of Sarpogrelate

Traditional administration of Clopidogrel

OTHER

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

Drug: Traditional administration of Clopidogrel

Interventions

Administration of Sarpogrelate DRUG

Aspirin 100mg plus Sarpogrelate 100mg

Administration of Sarpogrelate

Traditional administration of Clopidogrel DRUG

Aspirin 100mg plus Clopidogrel 75mg

Traditional administration of Clopidogrel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ewha Womans University Seoul Hospital: lead

MeSH Terms

Conditions

Stroke; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Sujin Han

CONTACT

820269862635; sujinhan1004@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: May 22, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share