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Trial record 13 of 1274 for:    ASPIRIN AND Platelet Aggregation

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

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ClinicalTrials.gov Identifier: NCT01108588
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 20, 2010
First Posted Date  ICMJE April 22, 2010
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • 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 ]
  • The intra-subject coefficient of variation of each of the 3 platelet function devices [ Time Frame: Baseline and 3 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01108588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Cross-over Study Using Aspirin and Clopidogrel to Assess Reproducibility and Compare Platelet Function Assays
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Placebo (to match Aspirin)
    Placebo grossly matched Aspirin 300 mg daily
  • Drug: Aspirin
    Aspirin 300 mg daily
  • Drug: Clopidogrel
    Clopidogrel 75 mg daily
  • Drug: Comparator: Placebo (to match Clopidogrel)
    Placebo (grossly matched Clopidogrel 75 mg) daily
Study Arms  ICMJE
  • Experimental: Sequence 1
    Aspirin - Clopidogrel - Placebo
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
  • Experimental: Sequence 2
    Clopidogrel - Placebo - Aspirin
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
  • Experimental: Sequence 3
    Placebo - Aspirin - Clopidogrel
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
  • Experimental: Sequence 4
    Aspirin - Placebo - Clopidogrel
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
  • Experimental: Sequence 5
    Clopidogrel - Aspirin - Placebo
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
  • Experimental: Sequence 6
    Placebo - Clopidogrel - Aspirin
    Interventions:
    • Drug: Placebo (to match Aspirin)
    • Drug: Aspirin
    • Drug: Clopidogrel
    • Drug: Comparator: Placebo (to match Clopidogrel)
Publications * 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. doi: 10.3109/09537104.2011.604806. Epub 2011 Sep 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 20, 2010)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium
 
Administrative Information
NCT Number  ICMJE NCT01108588
Other Study ID Numbers  ICMJE 0000-167
167
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP