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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01108588

167

0000-167

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Aspirin - Clopidogrel - Placebo

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)

Sequence 2

Experimental group

Description:

Clopidogrel - Placebo - Aspirin

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)

Sequence 3

Experimental group

Description:

Placebo - Aspirin - Clopidogrel

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)

Sequence 4

Experimental group

Description:

Aspirin - Placebo - Clopidogrel

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)

Sequence 5

Experimental group

Description:

Clopidogrel - Aspirin - Placebo

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)

Sequence 6

Experimental group

Description:

Placebo - Clopidogrel - Aspirin

Treatment:

Drug: Comparator: Placebo (to match Clopidogrel)

Drug: Clopidogrel

Drug: Aspirin

Drug: Placebo (to match Aspirin)