Key result
DG-041 partially inhibited platelet function ex-vivo and provided significantly greater inhibition when combined with clopidogrel, without increasing bleeding time.
Why the study?
Does the EP3 receptor antagonist DG-041 inhibit platelet function without increasing bleeding time when used alone or in combination with clopidogrel and aspirin in healthy volunteers?
Population
Healthy volunteers for the ex-vivo clinical study, and whole blood samples for the in-vitro study.
Comparison
DG-041 for 5 days, administered alone or… vs Matching placebo for 5 days, administered alone…
Design
RCT, randomised, blocked, crossover, blinded (for DG-041/matching placebo)
Follow-up
10 days
Authors
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Supports DG-041 evaluation with P2Y12 inhibitors in patients; extends additive inhibition data to combinations without bleeding signal.
RCT (n=42)
blinded
blocked, crossover
Does the EP3 receptor antagonist DG-041 inhibit platelet function without increasing bleeding time when used alone or in combination with clopidogrel and aspirin in healthy volunteers?
The EP3 receptor antagonist DG-041 provides additional inhibition of platelet function when combined with P2Y12 blockade without further increasing bleeding time.
Fox et al. (2012) conducted an RCT in Healthy volunteers (n=42). DG-041 vs. placebo was evaluated on Platelet effects and bleeding time. DG-041 partially inhibited platelet function ex-vivo and provided significantly greater inhibition when combined with clopidogrel, without increasing bleeding time.
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