CClinicalTrials.gg
Sign In
CompletedNCT01108588Updated Aug 13, 2015

Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)

A Phase 1 interventional study of Placebo (to match Aspirin) and Aspirin in Healthy Volunteers, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-13.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subject has BMI (Body Mass Index) less than 32 kg/m\^ 2
  • Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months
  • Subject does not have a history of any bleeding disorder

Exclusion criteria

Exclusion Criteria:

  • Subject is a pregnant or nursing female
  • Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention)
  • Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin)
  • Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort)
  • Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies
  • Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study
  • Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years
  • Subject has a history of poor wound healing or a tendency to form keloids
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Sequence 1

    Aspirin - Clopidogrel - Placebo

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

  • Experimental
    Sequence 2

    Clopidogrel - Placebo - Aspirin

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

  • Experimental
    Sequence 3

    Placebo - Aspirin - Clopidogrel

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

  • Experimental
    Sequence 4

    Aspirin - Placebo - Clopidogrel

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

  • Experimental
    Sequence 5

    Clopidogrel - Aspirin - Placebo

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

  • Experimental
    Sequence 6

    Placebo - Clopidogrel - Aspirin

    Drug: Placebo (to match Aspirin) · Drug: Aspirin · Drug: Clopidogrel · Drug: Comparator: Placebo (to match Clopidogrel)

Interventions

  • DrugPlacebo (to match Aspirin)

    Placebo grossly matched Aspirin 300 mg daily

  • DrugAspirin

    Aspirin 300 mg daily

  • DrugClopidogrel

    Clopidogrel 75 mg daily

  • DrugComparator: Placebo (to match Clopidogrel)

    Placebo (grossly matched Clopidogrel 75 mg) daily

06

What researchers measure

Primary outcomes

  1. The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment.

    Time frame: Baseline and 3 days

  2. The intra-subject coefficient of variation of each of the 3 platelet function devices

    Time frame: Baseline and 3 days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Chen F, Maridakis V, O'neill EA, Beals C, Radziszewski W, de Lepeleire I, Van Dyck K, Depre M, Bolognese JA, de Hoon J, Jacquemin M. A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel. Platelets. 2012;23(4):249-58. doi: 10.3109/09537104.2011.604806. Epub 2011 Sep 15. PubMed 21919555 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01108588
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Apr 22, 2010
Start date
Jun 2010
Primary completion
Aug 2010
Completion
Aug 2010
Last update
Aug 13, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Merck Sharp & Dohme LLC

Start the discussion