HealthyPhase 1CiloMecTNCT02554721

Pharmacodynamic Study of Cilostazol in Healthy Volunteers

A Phase 1 study testing Cilostazol, Acetylsalicylic acid and Clopidogrel in people with Healthy, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Cilostazol, Acetylsalicylic acid and Clopidogrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteGermany
Study dates: Aug 2015to 30 Mar 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Bad Krozingen

Other trials in Germany

About this study

Official 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

Conditions: Healthy
Being tested: Cilostazol, Acetylsalicylic acid, Clopidogrel
Keywords: Healthy Volunteers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CilostazolDrug
Acetylsalicylic acidDrug
ClopidogrelDrug

Study groups in NCT02554721
Study group	Role	What they receive
Group 1 (CYP2C19 Wild Type)	Experimental	Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28) Receives: Drug: Cilostazol; Drug: Acetylsalicylic acid
Group 2 (CYP2C19 Wild Type)	Experimental	Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28) Receives: Drug: Cilostazol; Drug: Clopidogrel
Group 3 (CYP2C19 heterozygous (1/2) )	Experimental	Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28) Receives: Drug: Cilostazol; Drug: Clopidogrel
Group 4 (CYP2C19 homozygous (2/2))	Experimental	Trial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28) Receives: Drug: Cilostazol; Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Ex-vivo Inhibition Of Platelet Aggregation (IPA)
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.
Measured: Baseline, Visit 5 (Day 22-29)

Secondary outcomes (1)

Effects On Skin Bleeding Time (BT)
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.
Measured: Visit 5 (Day 22-29)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201530 Mar 2018

First posted18 Sep 2015 (estimated)
Study startAug 2015
Primary completion30 Mar 2018
Study completion30 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02554721
Sponsor's protocol ID: 21-13-102
Other IDs: 2013-002633-38
Acronym: CiloMecT
Status last verified: Sep 2021
First submitted: 15 Sep 2015
Last updated: 13 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02554721
Acronym / sponsor ID: CiloMecT / 21-13-102
Conditions: Healthy
Keywords: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Aug 2015 (actual)
Primary completion: 30 Mar 2018 (actual)
Study completion: 30 Mar 2018 (actual)
First posted: 18 Sep 2015 (estimated)
Results: Posted 13 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Group 1 (CYP2C19 Wild Type)	Experimental	Drug: Cilostazol, Drug: Acetylsalicylic acidTrial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Acetylsalicylic acid 100 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Acetylsalicylic acid 100mg once daily for 1 week (Days 22-28)
Group 2 (CYP2C19 Wild Type)	Experimental	Drug: Cilostazol, Drug: ClopidogrelTrial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
Group 3 (CYP2C19 heterozygous (1/2) )	Experimental	Drug: Cilostazol, Drug: ClopidogrelTrial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)
Group 4 (CYP2C19 homozygous (2/2))	Experimental	Drug: Cilostazol, Drug: ClopidogrelTrial period A: Cilostazol 100 mg twice daily for 1 week (Days 1-7) Trial period B: Wash out period (Days 8-14) Trial period C: Clopidogrel 75 mg once daily for 1 week (Days 15-21) Trial period D: Cilostazol 100 mg twice daily and Clopidogrel 75 mg once daily for 1 week (Days 22-28)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cilostazol	Drug	Group 1 (CYP2C19 Wild Type), Group 2 (CYP2C19 Wild Type), Group 3 (CYP2C19 heterozygous (1/2) ), Group 4 (CYP2C19 homozygous (2/2))
Acetylsalicylic acid	Drug	Group 1 (CYP2C19 Wild Type)
Clopidogrel	Drug	Group 2 (CYP2C19 Wild Type), Group 3 (CYP2C19 heterozygous (1/2) ), Group 4 (CYP2C19 homozygous (2/2))

Primary outcome

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.

1 secondary outcome

Effects On Skin Bleeding Time (BT)
Time frame: Visit 5 (Day 22-29)

Results and safety

Results posted to the registry on 13 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 (CYP2C19 EM)	20	19
Group 2 (CYP2C19 EM)	19	19
Group 3 (CYP2C19 IM)	19	19
Group 4 CYP2C19 PM)	17	17
Not Assigned	2	0

Primary outcome: Ex-vivo Inhibition Of Platelet Aggregation (IPA)

Time frame: Baseline, Visit 5 (Day 22-29). Geometric mean (95% Confidence Interval). Unit: ratio

Measure	Acetylsalicylic Acid - Cilostazol n = 15	Clopidogrel - Cilostazol n = 51
5 µM ADP	0.82 (0.5 to 1.37)	1.21 (1.09 to 1.35)
500 mg/L AA	1.03 (1.01 to 1.05)	4.42 (3.42 to 5.73)

Population analysed: Full Analysis Set: All subjects who completed both periods of treatment with reference medication alone (Period C) and treatment with reference medication and cilostazol (Period D)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Treatment-emergent adverse events were collected from Day 1 to Day 29. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cilostazol	0 of 77 (0%)	62 of 77 (80.5%)	0 of 77
Acetylsalicylic Acid	0 of 20 (0%)	3 of 20 (15%)	0 of 20
Clopidogrel	0 of 55 (0%)	3 of 55 (5.5%)	0 of 55
Acetylsalicylic Acid - Cilostazol	0 of 20 (0%)	10 of 20 (50%)	0 of 20
Clopidogrel - Cilostazol	0 of 55 (0%)	41 of 55 (74.5%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Osamu Sato study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cilostazol, Acetylsalicylic acid and Clopidogrel in people with Healthy, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ex-vivo Inhibition Of Platelet Aggregation (IPA) (time frame: Baseline, Visit 5 (Day 22-29)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02554721.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2021.