Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-15
Brief Title:
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
Sponsor:
Ewha Womans University Seoul Hospital
Organization:
Ewha Womans University Seoul Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11
The researcher allocates 11 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 aspirinsarpogrelate and aspirinclopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication
In this clinical trial the intervention group and the control group are assigned 11
The researcher allocates 11 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 aspirinsarpogrelate and aspirinclopidogrel in stroke patients with decreased ankle-brachial arterial pressure index and intermittent claudication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None