What question did this study set out to answer?

To identify an easy-to-use, quantitative point-of-care device with minimal technical variability to evaluate platelet aggregation during antiplatelet drug development.

September 15, 2011Platelets

A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel

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Why the study?

Do point-of-care platelet function assays reliably quantitate the effects of aspirin or clopidogrel compared to bleeding time and light transmission aggregometry in healthy volunteers?

Population

Healthy volunteers

Comparison

3 days of treatment with aspirin or clopidogrel vs Placebo for 3 days

Design

RCT, randomized, three-period cross-over, double-blind, placebo-controlled

Follow-up

3 days

Authors

FCFabian ChenRoyal Berkshire Hospital VMVictor MaridakisMerck & Co., Inc., Rahway, NJ, USA (United States)EOEdward A. O’NeillSpringfield College

Discussion

Member takes

Implication

May simplify antiplatelet monitoring in practice; confirms point-of-care device reliability versus traditional assays in RCT.

Key Points

To identify an easy-to-use, quantitative point-of-care device with minimal technical variability to evaluate platelet aggregation during antiplatelet drug development.
Conducted a double-blind, placebo-controlled, randomized, three-period crossover study in healthy volunteers.
Administered 3-day treatment regimens of aspirin, clopidogrel, or placebo across separate study periods.
Compared platelet responses using bleeding time, light transmission aggregometry, and three point-of-care devices: Multiplate, Platelet Function Analyzer-100, and VerifyNow.
All three point-of-care devices demonstrated standardized effect sizes greater than or similar to bleeding time and light transmission aggregometry across all treatment comparisons.
VerifyNow yielded the highest standardized effect size for detecting the effect of aspirin versus placebo.
Multiplate demonstrated the highest standardized effect size for detecting the effect of clopidogrel versus placebo.

Structured PICO

Do point-of-care platelet function assays reliably quantitate the effects of aspirin or clopidogrel compared to bleeding time and light transmission aggregometry in healthy volunteers?

Population

Healthy volunteers

Intervention

3 days of treatment with aspirin or clopidogrel

Comparator

Placebo for 3 days

Outcome

Effect size (difference in treatment means divided by the pooled standard deviations) to quantitate the effects on platelet functionsurrogate

Point-of-care platelet function devices (Multiplate, PFA-100, VerifyNow) can reliably assess the antiplatelet effects of aspirin and clopidogrel, offering a simpler alternative to traditional bleeding time and light transmission aggregometry.

Cite This Study

Chen et al. (2011) studied this question.

synapsesocial.com/papers/6a89cf5581d3bfa98ef7df77 https://doi.org/10.3109/09537104.2011.604806

Topics

Dual antiplatelet therapy

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A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Topics

A randomized clinical trial comparing point-of-care platelet function assays and bleeding time in healthy subjects treated with aspirin or clopidogrel

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Also Consider

Topics

Also Consider