Bad Krozingen, Germany
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–45 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1
Primary location
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
Drugacetylsalicylic acid
Drugclopidogrel
DrugPrimary outcomes
-
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
-
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Neural Control of Kidney Blood Flow During Exercise in African American Adults
NCT03981640
Behavior, Behavioral Symptoms
Boston, Massachusetts, United States
View Trial DetailsA Study of SPY002-091 in Healthy Volunteers
NCT06672718
Healthy
Cypress, California, United States
View Trial DetailsA Study of the Effects of Itraconazole on LY4395089 in Healthy Participants
NCT07592572
Healthy
Lenexa, Kansas, United States
View Trial DetailsA Study of SPY002-072 in Healthy Volunteers
NCT06622070
Healthy
Cypress, California, United States
View Trial Details