Table 3
Author, country, datePatient groupStudy typeOutcomesKey resultsStudy weaknesses
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 trialFirst primary composite outcome (CV death, MI or Stroke)9.3% clopidogrel v/s 11.4% placebo (p,0.001) RR 0.80 CI 0.72–0.92Patients 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 bleeding8.5% clopidogrel v/s 5.0% placebo (p<0.001) RR 1.69
Major bleeding3.7% 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 bleeding5.1% clopidogrel v/s 2.4% placebo (p<0.001) RR 2.12
Life-threatening bleeding2.2% clopidogrel v/s 1.8% placebo (p = 0.12).
Myocardial infarction5.2% clopidogrel v/s 6.7% placebo. RR 0.77 (0.67–0.89).
Incidence of second primary outcome by 24 hours1.4% 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 limitRetrospective sub-group analysis of the CURE trialLow - 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 63Retrospective 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