A Study to Compare the Effects of Sarpogrelate Sustained... | NCT05730621

Studies
A Study to Compare the Effects of Sarpogrelate Sustained Release /Aspirin Combination Therapy Versus Aspirin on Blood Viscosity in the Patients With Peripheral Arterial Disease and Coronary Artery Disease

NCT05730621

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

Jan 22, 2025Actual

Enrollment

68Actual

Phase

Phase 4

Conditions

Sarpogrelate
Blood Viscosity
Peripheral Arterial Disease
Coronary Artery Disease

Interventions

Sarpogrelate Sustained Release/Aspirin
Aspirin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 11, 2023Actual

Primary Completion Date

Feb 28, 2024Actual

Completion Date

Feb 28, 2024Actual

First Submitted Date

Jan 26, 2023

First Submission Date that Met QC Criteria

Feb 6, 2023

First Posted Date

Feb 16, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2025

Last Update Posted Date

Jan 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sarpogrelate Sustained Release/Aspirin	Experimental	Sarpogrelate Sustained Release/Aspirin Combination Therapy for 12 weeks	Drug: Sarpogrelate Sustained Release/Aspirin
Aspirin	Active Comparator	Aspirin Monotherapy qd for 12 weeks	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sarpogrelate Sustained Release/Aspirin	Drug	Aspirin 100mg qd and Sarpogrelate Sustained Release 300mg qd for 12 weeks	Sarpogrelate Sustained Release/Aspirin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline to week 12 in Blood Viscosity(cP, centipoise) measured by the blood viscometer		Baseline/Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline to week 4 in Blood Viscosity(cP, centipoise) measured by the blood viscometer		Baseline/Week 4
Change from baseline to week 4, 12 in Erythrocyte Deformability(elogation index at 3Pa) measured by Microfluidic Scanning Method		Baseline/Week 4/Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both man and woman who is over 19 years old
Identified as 10-75% of Stenosis in Coronary Angiography or Coronary CTA(Coronary computed tomography angiography)
Patients who diagnosed with peripheral artery disease or has symptoms
Written informed consent

Exclusion Criteria:

Patients who is scheduled surgery due to coronary artery disease or cerebral infarction disease.
Patients who have taken aspirin within two weeks before randomization
Patients who need antiplatelet or anticoagulant medication except Aspirin
Confirmed below results at screening
- Hemoglobin <13g/dL
- Platelet <60,000/µL
- Severe kidney disease patient with eGFR(estimated Glomerular Filtration Rate) <30 mL/min/1.73 m2 (CKD-EPI)
Patients with a history of cerebrovascular and cardiovascular complications (brain infarction, transient cerebral ischemic seizures, myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary artery intervention) within the last six months
Patients with bleeding
Pregnant or lactating women
Those participating in other clinical trials for investigational products
Patients deemed to be ineligible to participate in the trial by investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

ID	Term
D058729	Peripheral Arterial Disease
D003324	Coronary Artery Disease