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Completed

NCT Number: NCT01108588

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo (to match Aspirin)

Drug

Placebo grossly matched Aspirin 300 mg daily

Aspirin

Drug

Aspirin 300 mg daily

clopidogrel

Drug

Clopidogrel 75 mg daily

Comparator: Placebo (to match Clopidogrel)

Drug

Placebo (grossly matched Clopidogrel 75 mg) daily

Primary outcomes

  1. 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

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

    Time frame: Baseline and 3 days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 22, 2010
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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