A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Phase 4

Completed

• Conditions: Peripheral Artery Disease, PAD
• Interventions: Drug: Anplag Tab. 100mg bid; Drug: Anplag Tab. 100mg tid

• Registration Number: NCT03509922
• Lead Sponsor: Yuhan Corporation

Brief Summary

This study is to evaluate the effect of sarpogrelate on blood viscosity after 24 weeks in patients with high blood viscosity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Study Start: 2018-10-11
• Primary Completion: 2019-12-26
• Study Completion: 2020-03-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-21
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients diagnosed with PAD* (*Criteria for diagnosis of PAD: diagnosed with Burger's disease, obstructive arteriosclerosis, diabetic peripheral vascular disease, or with ischemic symptoms such as ulcers, pain, cold sensation, etc.)
2. tODI < 3 at randomization
3. Aged ≥ 19 years
4. Written informed consent

Exclusion Criteria

1. Patients requiring acute or two or more antiplatelet agents

2. Patients requiring anticoagulant therapy

3. Patients requiring surgical procedure due to vascular occlusion

4. Patients whose results are confirmed at the screening as follows:

   • hemoglobin (Hb) test value: male < 13 g/dL, female < 12 g/dL
   • platelet count < 60,000/µL
   • severe renal disease (eGFR < 30 mL/min/1.73 m2)

5. Patients with a history of cerebrovascular and cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, percutaneous coronary intervention) within the last 6 months

6. Contraindications stated in the SPC of sarpogrelate

7. Patients who are pregnant or planning to become pregnant

8. Those participating in other clinical trials with administration of investigational products at the screening

9. Those who are deemed to be ineligible to participate in the trial by investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anplag Tab. 100mg bid	Anplag Tab. 100mg bid	sarpogrelate hydrochloride 100mg bid for 24 weeks
Anplag Tab. 100mg tid	Anplag Tab. 100mg tid	sarpogrelate hydrochloride 100mg tid for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to week 24 in tissue oxygen delivery index (tODI)	baseline, week 24

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with tODI elevated by 20% or more	baseline, week 12, week 24
Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)	baseline, week 24
Change from baseline to week 12 in tODI	baseline, week 12

Trial Locations

Locations (1)

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital; 🇰🇷 Uijeongbu, Gyeonggido, Korea, Republic of