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

NCT01108588 | Completed Phase 1

• 2 other identifiers: 0000-167167
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 3 days

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

  Baseline and 3 days

Study Arms (6)

Sequence 1

EXPERIMENTAL

Aspirin - Clopidogrel - Placebo

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

Sequence 2

EXPERIMENTAL

Clopidogrel - Placebo - Aspirin

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

Sequence 3

EXPERIMENTAL

Placebo - Aspirin - Clopidogrel

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

Sequence 4

EXPERIMENTAL

Aspirin - Placebo - Clopidogrel

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

Sequence 5

EXPERIMENTAL

Clopidogrel - Aspirin - Placebo

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

Sequence 6

EXPERIMENTAL

Placebo - Clopidogrel - Aspirin

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

Interventions

Placebo (to match Aspirin) DRUG

Placebo grossly matched Aspirin 300 mg daily

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Aspirin DRUG

Aspirin 300 mg daily

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Clopidogrel DRUG

Clopidogrel 75 mg daily

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Comparator: Placebo (to match Clopidogrel) DRUG

Placebo (grossly matched Clopidogrel 75 mg) daily

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 21919555 DERIVED

MeSH Terms

Interventions

Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: August 13, 2015

Record last verified: 2015-08