Individualised Antiplatelet Therapy
Table 3: Studies Evaluating the Merit of Changing Therapy Based on Platelet Reactivity Study
Design and GRAVITAS107
Estimated Accrual (n) Design:
Treatment, randomised, double-blind, placebo- controlled, parallel assignment, safety/ efficacy study
Estimated accrual: ACS–PCI–DES (2,783)
ARCTIC108 Design:
Treatment, randomised, open-label, active control, parallel assignment, safety/efficacy study
Estimated accrual: Elective PCI–DES (2,500)
Second randomisation after one year of follow-up: C: Pursuit arm: Pursuit of a dual oral antiplatelet therapy (aspirin and clopidogrel) beyond one year. D: Interruption arm: Interruption of clopidogrel therapy.
DANTE109 Design:
Treatment, randomised, open-label, active control, parallel assignment,
efficacy study Estimated accrual:
TOPAS-1110
Unstable or NSTEMI–PCI (442) Design:
A: Active comparator:
Screening, non-randomised, Patients with previously experienced ST while on dual antiplatelet open-label, active control, parallel assignment,
treatment within 6 months after coronary stenting for CAD; clopidogrel 75mg once daily. Patients not already on clopidogrel
pharmacodynamics study Estimated accrual:
Previous PCI or stenting for CAD (450)
treatment will receive a loading dose of clopidogrel 600mg. B: Active comparator:
Patients with previously experienced MI while on dual antiplatelet treatment within 6 months after coronary stenting for CAD;
clopidogrel 75mg once daily. Patients not already on clopidogrel treatment will receive a loading dose of clopidogrel 600mg. C: Active comparator:
TRIGGER-PCI111 Design:
Treatment, randomised, double-blind, active-
Patients without previously experienced MI or ST within 6 months after coronary stenting for CAD (matched controls for group A and B); clopidogrel 75mg once daily. Patients not already on clopidogrel treatment will receive a loading dose of clopidogrel 600mg. A: Experimental (drug: prasugrel):
One-time 60mg oral loading dose and 10mg once-daily oral maintenance dose up to 6 months.
controlled, parallel assignment, B: Active comparator (drug: clopidogrel): safety/efficacy study
Estimated accrual: CAD–DES (2,150)
ACS = acute coronary syndromes; CAD = coronary artery disease; CV = cardiovascular; DES = drug-eluting stent; MACE = major cardiovascular events; MI = myocardial infarction; NSTEMI = non-ST-segment-elevation myocardial infarction; PCI = percutaneous coronary intervention; ST = stent thrombosis; TLVR = target lesion vessel revascularisation.
care platelet function test). A composite end-point of death, MI, stroke, urgent coronary revascularisation and stent thrombosis will be assessed at one-year follow-up.
INTERVENTIONAL CARDIOLOGY Future Perspectives
Studies show point-of-care platelet function tests to be promising for the measurement of patient response to antiplatelet therapy, with the
101 75mg oral daily maintenance dose up to 6 months.
VerifyNow P2Y12 (platelet reactvitiy units).
Time-frame: within 6 months
A: Placebo comparator: standard therapy: Clopidogrel 75mg/day.
B: Active comparator: doubled therapy: Clopidogrel 150mg/day.
6- and 12-month incidence of MACE (CV death, non-fatal MI, TLVR by PCI or coronary bypass).
Treatment Arms A: Active comparator:
‘Tailored’ clopidogrel regimen – clopidogrel 450mg loading dose then clopidogrel 75mg daily for 6 months. B: Placebo comparator:
‘Standard’ clopidogrel regimen – a placebo loading dose and Responders: a random sample of clopidogrel responders treated
with a placebo loading dose and then the standard clopidogrel regimen of 75mg and 1 placebo tablet every day for 6 months. First randomisation: A: Monitoring arm:
Dose adjustment of both aspirin and clopidogrel in suboptimal responders identified based on a point of care assay (VerifyNow). B: Conventional arm:
Fixed-dose regimen of both aspirin and clopidogrel in all patients following DES implantation according to international guidelines.
Composite end-point of death, MI, stroke, ST and urgent coronary
revascularisation assessed at specified time-points (one year in both
‘monitoring’ and ‘conventional’ arms and during the period from 6 up to 18 months in the ‘interruption’ and ‘pursuit’ arms).
Primary Outcome Measure Time to first occurrence of post-
randomisation CV death, non-fatal MI or ARC definite/probable ST in non- responders randomised to standard versus tailored dosage.
then clopidogrel 75mg and 1 placebo tablet every day for 6 months. Time-frame: 6 months. C: Placebo comparator:
Time to first occurrence of heart attack or CV death.
Time-frame: through 6 months.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60 |
Page 61 |
Page 62 |
Page 63 |
Page 64 |
Page 65 |
Page 66 |
Page 67 |
Page 68 |
Page 69 |
Page 70 |
Page 71 |
Page 72 |
Page 73 |
Page 74 |
Page 75 |
Page 76 |
Page 77 |
Page 78 |
Page 79 |
Page 80 |
Page 81 |
Page 82 |
Page 83 |
Page 84 |
Page 85 |
Page 86 |
Page 87 |
Page 88 |
Page 89 |
Page 90 |
Page 91 |
Page 92 |
Page 93 |
Page 94 |
Page 95 |
Page 96 |
Page 97 |
Page 98 |
Page 99 |
Page 100 |
Page 101 |
Page 102 |
Page 103 |
Page 104 |
Page 105 |
Page 106 |
Page 107 |
Page 108 |
Page 109 |
Page 110 |
Page 111 |
Page 112 |
Page 113 |
Page 114 |
Page 115 |
Page 116