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August 6, 2012Platelets

Effects on platelet function of an EP3 receptor antagonist used alone and in combination with a P2Y12antagonist bothin-vitroandex-vivoin human volunteers

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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

SFSue FoxJMJane MayAJAndrew J. Johnson

Discussion

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Overview

Supports DG-041 evaluation with P2Y12 inhibitors in patients; extends additive inhibition data to combinations without bleeding signal.

Study Design

Type

RCT (n=42)

Blinding

blinded

Randomization

blocked, crossover

Structured PICO

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?

P
Population
42 healthy volunteers in a crossover study evaluating the antiplatelet effects of DG-041 alone and in combination with clopidogrel or clopidogrel and aspirin.
I
Intervention
DG-041 (200 mg twice daily) for 5 days, administered alone or alongside clopidogrel (300 mg loading dose plus 75 mg daily) or clopidogrel and aspirin (75 mg daily).
C
Comparator
Matching placebo for 5 days, administered alone or alongside the same background treatments (clopidogrel or clopidogrel and aspirin).
O
Outcome
Platelet aggregation, P-selectin expression, and bleeding time measured at baseline, days 5 and 10.surrogate

The EP3 receptor antagonist DG-041 provides additional inhibition of platelet function when combined with P2Y12 blockade without further increasing bleeding time.

Cite This Study

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.

synapsesocial.com/papers/6a939579213a779dfe720656https://doi.org/10.3109/09537104.2012.704648
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1DG-041 inhibits the EP3 prostanoid receptor—A new target for inhibition of platelet function in atherothrombotic disease2008 · 68 citations
  2. 2Antagonists of the EP<sub>3</sub> Receptor for Prostaglandin E<sub>2</sub> Are Novel Antiplatelet Agents That Do Not Prolong Bleeding2009 · 69 citations
  3. 3Relationship between degree of P2Y12 receptor blockade and inhibition of P2Y12-mediated platelet function2010 · 78 citations
  4. 4The role of prostanoid receptors in mediating the effects of PGE<sub>2</sub>on human platelet function2010 · 61 citations
  5. 5Selective activation of the prostaglandin E2 receptor subtype EP2 or EP4 leads to inhibition of platelet aggregation2010 · 45 citations