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

A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Clopidogrel; Drug: Placebo (to match Aspirin); Drug: Aspirin; Drug: Comparator: Placebo (to match Clopidogrel)

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Aspirin - Clopidogrel - Placebo	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 2; Clopidogrel - Placebo - Aspirin	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 3; Placebo - Aspirin - Clopidogrel	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 4; Aspirin - Placebo - Clopidogrel	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 5; Clopidogrel - Aspirin - Placebo	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 6; Placebo - Clopidogrel - Aspirin	Drug: Clopidogrel; Clopidogrel 75 mg daily; Drug: Placebo (to match Aspirin); Placebo grossly matched Aspirin 300 mg daily; Drug: Aspirin; Aspirin 300 mg daily; Drug: Comparator: Placebo (to match Clopidogrel); Placebo (grossly matched Clopidogrel 75 mg) daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 11, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Aspirin; Clopidogrel
• Other Study ID Numbers: 0000-167; 167