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Completed

NCT Number: NCT03509922

A Study to Evaluate the Effect of Sarpogrelate on Blood Hyperviscosity

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

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Key information

Conditions

Peripheral Artery Disease, PAD Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, Gyeonggido, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.)
  • tODI < 3 at randomization
  • Aged ≥ 19 years
  • Written informed consent

Exclusion criteria

  • Patients requiring acute or two or more antiplatelet agents
  • Patients requiring anticoagulant therapy
  • Patients requiring surgical procedure due to vascular occlusion
  • 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)
  • 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
  • Contraindications stated in the SPC of sarpogrelate
  • Patients who are pregnant or planning to become pregnant
  • Those participating in other clinical trials with administration of investigational products at the screening
  • Those who are deemed to be ineligible to participate in the trial by investigator

Treatment and study plan

Anplag Tab. 100mg bid

Drug

sarpogrelate hydrochloride 100mg bid for 24 weeks

Other names: Sarpogrelate 200mg

Anplag Tab. 100mg tid

Drug

sarpogrelate hydrochloride 100mg tid for 24 weeks

Other names: Sarpogrelate 300mg

Primary outcomes

  1. Change from baseline to week 24 in tissue oxygen delivery index (tODI)

    Time frame: baseline, week 24

Secondary outcomes

  1. Change from baseline to week 12 in tODI

    Time frame: baseline, week 12

  2. Proportion of subjects with tODI elevated by 20% or more

    Time frame: baseline, week 12, week 24

  3. Change from baseline to week 24 in 36-Item Short Form Health Survey (SF-36)

    Time frame: baseline, week 24

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 26, 2018
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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