Table 2.
Clopidogrel trials and outcomes
| Trial | Study drug | N | 10 endpoints | Outcomes/comments |
|---|---|---|---|---|
| PCI-CURE | 300 mg Clopidogrel loading (Clopidogrel given median 10 days before PCI) Placebo |
1,313 1,345 |
Composite endpoints of CV death, MI, or urgent revascularization by 30 days after PCI | Compared with placebo, clopidogrel ↓ the risks of composite endpoints by nearly 1/3 (RR = 0.70, P = 0.03) |
| CREDO | 300 mg Clopidogrel loading Placebo |
1,053 1,063 |
Combined risks of death, MI or urgent revascularization @ day 28 | No difference between the 2 treatment groups Post-hoc: Clopidogrel better if given >15 hrs before PCI |
| ARMYDA-2 | 600 mg clopidogrel loading 300 mg clopidogrel loading |
126 129 |
Combined risks of death, MI, or target vessel revascularization @ 30 days | 600 mg versus 300 mg, no difference (P = 0.041) Multivariate analysis: 50% ↓ peri-procedure MI with 600 mg clopidogrel Comparable safety |
| CURRENT-OASIS 7* | Clopidogrel analysis: 600 mg loading, followed by 150 mg × 7 days, then 75 mg daily 300 mg loading, followed by 75 mg daily | 12,508 12,579 |
Composite endpoints of CV death, MI, or stroke @ 30 days | 600 mg versus 300 mg, no difference (P = 0.37) PCI subgroup: ↓ Composite endpoints (HR 0.85, P = 0.036) and ↓ Definite stent thrombosis with high dose (P = 0.001) ↓ Current major and severe bleeding with high dose (P = 0.01) |
| ISAR-REACT | Duration of 600 mg clopidogrel treatment before PCI with or without abciximab (2–3 h, 3–6 h, 6–12 h, or >12 h) | 2,159 | Composite endpoints of death, MI, or urgent revascularization @ 30 days | No incremental benefit with clopidogrel pretreatment >2–3 h (P = 0.79) with or without abciximab |
| ISAR-CHOICE | Clopidogrel 300 mg, 600 mg, or 900 mg loading | 60 | Plasma concentrations of active and inactive clopidogrel metabolites, and unchanged clopidogrel; values for ADP-induced platelet aggregation 4 h after clopidogrel | 600 mg versus 900 mg No further increase in concentrations of metabolites (P = 0.59) or ADP-induced platelet aggregation (P = 0.39) |
*
Within each clopidogrel group (600 mg versus 300 mg loading), patients were randomized to receive high-dose or low-dose aspirin (300–325 mg or 75–100 mg).
Abbreviation: N, number of patients.