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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01108588
First received: April 20, 2010
Last updated: September 9, 2010
Last verified: September 2010
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Clopidogrel
Ticlopidine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014