TRIGGER-PCI stopped early

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The TRIGGER-PCI trial, comparing prasugrel 10 mg and clopidogrel 75 mg in patients with high platelet reactivity on clopidogrel after receiving a drug-eluting stent, has been stopped early because of a low rate of primary cardiovascular events (myocardial infarctions and cardiovascular deaths).

This was said to be likely due to the studied population – low-risk, stable coronary artery disease (CAD) patients after successful, uncomplicated percutaneous coronary intervention (PCI).

The sponsors of the study (Daiichi Sankyo and Eli Lilly) along with the study’s steering Committee and primary investigator, Dr Franz-Josef Neumann (Heart Centre, Bad Krozingen, Germany) determined after a blinded review of study data that there is a very high probability that the number of primary end points would be insufficient for clinically relevant statistical analyses.Prasugrel is currently approved only for use in acute coronary syndromes. This was the only study underway looking at its use in stable CAD patients.

A similar lower than expected event rate was seen in the GRAVITAS trial, which showed no difference in events with high dose and normal dose clopidogrel in a similar patient population to that in TRIGGER PCI.

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