A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Peripheral Artery Disease, PAD Clinical Trial

Official title:

A Randomized, Dose-controlled, Open-label, Parallel, 2-treatment Group, Single Center, Pilot Study to Evaluate the Effectiveness of Sarpogrelate on Blood Hyperviscosity in the Patients With Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509922
• Other study ID #: YMC036
• Status: Completed
• Phase: Phase 4
• Start date: October 11, 2018
• Est. completion date: March 5, 2020

Study information

• Verified date: June 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 5, 2020
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease, PAD
• Thrombophilia

Intervention

Drug:
• Anplag Tab. 100mg bid
sarpogrelate hydrochloride 100mg bid for 24 weeks
• Anplag Tab. 100mg tid
sarpogrelate hydrochloride 100mg tid for 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Uijeongbu ST. Mary's Hospital	Uijeongbu	Gyeonggido

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to week 24 in tissue oxygen delivery index (tODI)		baseline, week 24
Secondary	Change from baseline to week 12 in tODI		baseline, week 12
Secondary	Proportion of subjects with tODI elevated by 20% or more		baseline, week 12, week 24
Secondary	Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)		baseline, week 24