A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

Yuhan

Status and phase: Completed; Phase 4

Conditions: Peripheral Artery Disease, PAD

Treatments: Drug: Anplag Tab. 100mg tid; Drug: Anplag Tab. 100mg bid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03509922

YMC036

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Anplag Tab. 100mg bid

Experimental group

Description:

sarpogrelate hydrochloride 100mg bid for 24 weeks

Treatment:

Drug: Anplag Tab. 100mg bid

Anplag Tab. 100mg tid

Experimental group

Description:

sarpogrelate hydrochloride 100mg tid for 24 weeks

Treatment:

Drug: Anplag Tab. 100mg tid