This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.
This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel. This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
263
Cattedra di Cardiologia, Azienda Ospedaliera Universitaria di Ferrara
Ferrara, Fe, Italy
Troponin I or T elevation ratio at least three times the upper limit of normal.
Time frame: 48 hours
The incidence of myocardial infarction defined as elevation of CK-MB >1, ≥3 or ≥5 times the ULN in one or more blood sample(s).
Time frame: 30 days
Elevation of troponin levels above upper limit of normal in ratios different from the primary endpoint
Time frame: within 30 days
Bleeding rates
Time frame: 30 days
Stent thrombosis
Time frame: with the first year of follow-up
The rate of major adverse cardiovascular events
Time frame: at 30 days and 1 year
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