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

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers	Drug: Placebo (to match Aspirin) Drug: Aspirin Drug: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel)	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays

Resource links provided by NLM:

Drug Information available for: Aspirin Clopidogrel bisulfate

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
The intra-subject coefficient of variation of each of the 3 platelet function devices [ Time Frame: Baseline and 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	June 2010
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sequence 1 Aspirin - Clopidogrel - Placebo	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 2 Clopidogrel - Placebo - Aspirin	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 3 Placebo - Aspirin - Clopidogrel	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 4 Aspirin - Placebo - Clopidogrel	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 5 Clopidogrel - Aspirin - Placebo	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily
Experimental: Sequence 6 Placebo - Clopidogrel - Aspirin	Drug: Placebo (to match Aspirin) Placebo grossly matched Aspirin 300 mg daily Drug: Aspirin Aspirin 300 mg daily Other Name: Aspirin Drug: Clopidogrel Clopidogrel 75 mg daily Other Name: Clopidogrel Drug: Comparator: Placebo (to match Clopidogrel) Placebo (grossly matched Clopidogrel 75 mg) daily

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01108588

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen F, Maridakis V, O'neill EA, Beals C, Radziszewski W, de Lepeleire I, Van Dyck K, Depré 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. Epub 2011 Sep 15.

Responsible Party:	Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01108588 History of Changes
Other Study ID Numbers:	2010_527, 167
Study First Received:	April 20, 2010
Last Updated:	September 9, 2010
Health Authority:	Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:

Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on June 18, 2013