On-treatment PLAtelet Reactivity-guided Therapy Modification FOR ST-segment Elevation Myocardial Infarction
Status:
Terminated
Trial end date:
2018-01-01
Target enrollment:
Participant gender:
Summary
Adequate platelet inhibition with dual antiplatelet therapy is a key therapeutic goal after
primary percutaneous coronary intervention (PPCI), aimed at protecting against stent
thrombosis and increased mortality. Recent aggregometric assays have shown that up to one
third of acute coronary syndrome patients treated with clopidogrel have incomplete inhibition
of adenosine diphosphate(ADP)-induced platelet aggregation while the number of patients
treated with aspirin who have incomplete inhibition of thromboxane A2-induced platelet
aggregation (ASPI)is much lower. High on-treatment platelet reactivity (HTPR) has been
associated with an increased rate of ischemic events after PCI. However, recent large trials
did not show a clinical benefit of TPR-guided therapy modification in acute coronary syndrome
patients treated by PCI.
On-treatment PLAtelet reactivity-guided Therapy modification FOR ST-segment elevation
Myocardial infarction (PLATFORM) is an investigator-initiated, prospective, randomized,
parallel-group, controlled clinical trial designed to test the hypothesis that antiplatelet
therapy modification is superior to standard antiplatelet regimen among intermediate to
high-risk STEMI patients undergoing PPCI. The safety hypothesis is that compared with control
arm, interventional study arm will have similar rates of non-coronary artery bypass graft
surgery-related bleeding. Approximately 632 ST-elevation myocardial infarction (STEMI)
patients with intermediate to high-risk (RISK-PCI score >3) clinical features undergoing PPCI
will be randomly allocated to treatment modification or standard treatment. Low responders to
aspirin will receive 200 mg aspirin for 30 days. Low responders to clopidogrel will receive
180 mg ticagrelor for 1 year. Patients will be followed up to 1 year after PPCI.