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Completed

NCT Number: NCT02554721

Pharmacodynamic Study of Cilostazol in Healthy Volunteers

The primary objective of this study is to investigate the effects of Cilostazol, Acetylsalycylic acid and Clopidogrel alone as well as combinations of Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF) testing.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Bad Krozingen, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy Caucasian male subjects
  • Able to read, to write and to fully understand German language
  • Provision of written informed consent before screening and baseline
  • BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
  • Good general health as determined by the investigator by medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab

Exclusion criteria

  • Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms
  • Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6 month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
  • Use of antibiotics within thirty (30) days prior to screening and until baseline visit
  • Clinically significant abnormalities in medical history, physical examination, vital signs, electrocardiogram, baseline and safety lab
  • Supine pulse rate > 100 beats/min or <50 beats/min
  • Systolic blood pressure <100 or >140 mmHg
  • Diastolic blood pressure <50 or >90 mmHg
  • Concomitant use of any other medication including over-the-counter preparations

Treatment and study plan

Cilostazol

Drug

acetylsalicylic acid

Drug

clopidogrel

Drug

Primary outcomes

  1. Ex-vivo Inhibition Of Platelet Aggregation (IPA)

    Time frame: Baseline, Visit 5 (Day 22-29)

    The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on IPA was determined ex vivo in citrated platelet rich plasma (PRP) after stimulation of aggregation by low-level adenosine diphosphate (ADP) (5 micromolar [uM]) and arachidonic acid (AA) (500 milligrams/liter [mg/L]). Light transmission aggregometry (LTA) was used to measure residual aggregation (the percentage of aggregation 5 minutes after the addition of ADP or AA). Results are reported as the 95% confidence intervals for the reported geometric mean ratios (GMRs) ([cilostazol+reference (ASA or clopidogrel)]/reference) for IPA.

Secondary outcomes

  1. Effects On Skin Bleeding Time (BT)

    Time frame: Visit 5 (Day 22-29)

    The effect of ASA in combination with cilostazol and clopidogrel in combination with cilostazol on skin BT (minutes) was determined with the Ivy method, utilizing standardized bleeding with the Surgicutt device. Results include the 95% confidence intervals for the reported GMRs ([cilostazol+reference]/reference) for skin BT.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Effect of Cilostazol as an add-on Treatment to a Single Antiplatelet Agent (Acetylsalicylic Acid or Clopidogrel) on Platelet Function Testing and Bleeding Time in Healthy Volunteers

Acronym: CiloMecT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2015
Registry last updated
Oct 13, 2021

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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