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CURE Trial Investigators 2001
| 12,562 patients presenting with chest pain within 24 hrs of onset of symptoms with either ECG changes consistent with ischaemia (but not ST-elevation) or raised serum cardiac enzymes to twice normal upper limit. | Prospective, multi-centric placebo-controlled randomised trial | First primary composite outcome (CV death, MI or Stroke) | 9.3% clopidogrel v/s 11.4% placebo (p,0.001) RR 0.80 CI 0.72–0.92 | Patients were recruited from centres favouring conservativemanagement of ACS. In the initial study design patients over 60 years of age with no new ECG changes but a history of coronary artery disease were included. After recruiting the first 3000 patients, event rates were low (thus potentially rendering the trial underpowered) and this inclusion criteria was removed. Only patients with ECG changes or raised cardiac enzymes were treated, not all chest pain syndromes |
| Second primary outcome (CV death, MI, Stroke or Refractory ischaemia)) | 16.5% clopidogrel v/s 18.8% placebo (p<0.001) RR 0.86 CI 0.79–0.94 |
| All bleeding | 8.5% clopidogrel v/s 5.0% placebo (p<0.001) RR 1.69 |
| Major bleeding | 3.7% clopidogrel v/s 2.7% placebo (p<0.001) RR 1.38 |
| Randomised to receive either clopidogrel (300 mg loading followed by 75 mg od) (n = 6259) or placebo (n = 6303) plus aspirin for 3–12 months. | Minor bleeding | 5.1% clopidogrel v/s 2.4% placebo (p<0.001) RR 2.12 |
| Life-threatening bleeding | 2.2% clopidogrel v/s 1.8% placebo (p = 0.12). |
| Myocardial infarction | 5.2% clopidogrel v/s 6.7% placebo. RR 0.77 (0.67–0.89). |
| Incidence of second primary outcome by 24 hours | 1.4% clopidogrel v/s 2.1% placebo. RR 0.66 (0.51–0.86). |
| Budaj A. et al, 2002, Poland. | Patients presenting with symptoms within 24 hrs of onset with either 1) ECG changes consistent with ischaemia (but not ST-elevation) or 2) raised serum cardiac enzymes or markers to twice the normal upper limit | Retrospective sub-group analysis of the CURE trial | Low - risk group (TIMI 0-2) primary outcome rates, RR and NNT (for 12 mths, mean 9 mths) | 4.1% v/s 5.7% (p<0.04) RR 0.71; CI 0.52–0.97, NNT 63 | Retrospective subgroup analysis |
| Intermediate - risk group (TIMI 3–4) primary outcome rates, RR and NNT (for 12 mths, mean 9 mths) | 9.8% v/v 11.4% (p<0.03) RR 0.85 CI 0.74–0.98, NNT 63 |
| High-risk group (TIMI 5–7) primary outcome rates, RR and NNT (for 12 mths, mean 9 mths) | 15.9% v/s 20.7% (p<0.004) RR 0.73; CI 0.60–0.90, NNT 21 |