Tailoring treatment with tirofiban in patients showing resistance to aspirin and/or resistance to clopidogrel (3T/2R). Rationale for the study and protocol design.
OBJECTIVE
To assess whether glycoprotein IIb/IIIa inhibition using tirofiban in low risk patients undergoing percutaneous coronary intervention (PCI) may reduce the risk of periprocedural myocardial infarction compared to standard care in poor responders to aspirin and/or clopidogrel.


METHODS
We will enroll patients at ten European sites or more to participate in the Tailoring Treatment with Tirofiban in patients showing Resistance to aspirin and/or Resistance to clopidogrel (3T/2R) study with a pre-specified sample size of 240 patients out of 1,100 or more who will undergo screening. The primary outcome measure is troponin I or T elevation ratio at least three times the upper limit of normal within 48 h after completion of the PCI.


CONCLUSIONS
The results of 3T/2R study will evaluate whether tailored intensification of anti-platelet treatment based on poor individual response to oral anti-platelet agents may modulate the risk of periprocedural myocardial infarction during PCI. Our findings attempt at unraveling a new era of individualized anti-platelet treatment through the use of point-of-care assessment.
University of Ferrara, Cardiovascular Institute, Arcispedale S. Anna Hospital, Corso Giovecca 203, 44100 Ferrara, Italy. vlgmrc@unife.it
Marco
M
Valgimigli
Gianluca
G
Campo
Nicoletta
N
de Cesare
Pascal
P
Vranckx
Martial
M
Hamon
Dominick J
DJ
Angiolillo
Manel
M
Sabatè
Fabrizio
F
Ferrari
Alessandro
A
Furgieri
Carlo
C
Tumscitz
Alessandra
A
Repetto
Salvatore
S
Colangelo
Emanuele
E
Meliga
Moh'd
M
Kubbajeh
Giovanni
G
Parrinello
Gianfranco
G
Percoco
Roberto
R
Ferrari
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D001241:Aspirin / Q000008:administration & dosage*; D015415:Biomarkers / Q000097:blood; D000077144:Clopidogrel; D004311:Double-Blind Method; D004351:Drug Resistance; D005060:Europe; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology / Q000378:metabolism / Q000517:prevention & control*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D011446:Prospective Studies; D012107:Research Design; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077466:Tirofiban; D016896:Treatment Outcome; D019210:Troponin I / Q000097:blood; D020107:Troponin T / Q000097:blood; D014443:Tyrosine / Q000008:administration & dosage / Q000031:analogs & derivatives*
D015415:Biomarkers; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D019210:Troponin I; D020107:Troponin T; D014443:Tyrosine; D000077144:Clopidogrel; D000077466:Tirofiban; D013988:Ticlopidine; D001241:Aspirin