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TABLE 3. Randomized Clinical Trials of Clopidogrel Use to Treat Vascular Disease
Study (Year)
Subjects (n, % Female, Mean Age)
Treatment Arms
Mean Follow-Up Period
Primary End Point as Reported
RRR* (95% CI), P
Event Rate (%)
CLARITY TIMI28 (2005)68 Acute STEMI (<12 hours); Rx Lysis, ASA, ±heparin (3491, 19.7, 57 years) Clopidogrel 300 mg bolus, 75 mg once daily vs placebo 3.5 d Occluded infarct-related artery, death, MI prior to angiography (odds reduction of end point, 36%; 95% CI, 24 to 47; P<0.001) 30.9 15
21.7
PCI-CLARITY TIMI 28 (2005)69 Acute STEMI (<12 hours); Rx Lysis, ASA, ±heparin, & subsequent PCI (1863, 18.3, 57.3 years) Clopidogrel 300 mg bolus, 75 mg once daily vs placebo and clopidogrel after angiogram 30 d Cardiovascular death, MI, CVA from PCI to 30 days after randomization (adjusted OR, 0.54; 95% CI, 0.35 to 0.85; P=0.008) 41.9 3.6
6.2
COMMIT (CCS-2) (2005)70 Suspected acute MI; Rx Lysis 54%, heparin (45 852, 28, 61 years) Clopidogrel (no bolus) 75 mg once daily+ASA 162 mg once daily vs placebo+ASA 162 mg once daily Discharge date or 28 d Death, reinfarction, CVA (all-cause mortality RRR, 7% [1 to 13]; P=0.03) 9.0 (3.0 to 14.0), P=0.002 9.2
10.1
CURE (2001)71 Acute coronary syndrome (12 562, 38.5%, 64.2 years) Clopidogrel 300 mg bolus, 75 mg once daily+ASA 75 to 325 mg vs placebo+ASA 75 to 325 mg 9 m Cardiovascular death, nonfatal MI, CVA (RR, 0.80; 95% CI, 0.72 to 0.90; P<0.001) 20.0 9.3
11.4
PCI-CURE (2001)72 Acute coronary syndrome on PCI (2658, 30.2%, 61.5 years) Clopidogrel 300 mg bolus, 75 mg once daily+ASA 75 to 325 mg vs placebo+ASA 75 to 325 mg 8 m Cardiovascular death, MI, urgent target vessel revascularization (<30 days) (RR, 0.70; 95% CI, 0.50 to 0.97; P=0.03) 30.0 4.5
6.4
CREDO (2002)73 Elective PCI or high likelihood of PCI (2116, 28.7%, 61.7 years) Clopidogrel 300 mg bolus, 75 mg once daily+ASA 325 mg vs placebo+ASA 325 mg 1 y Death, MI, CVA 26.9 (3.9 to 44.4), P=0.02 8.5
11.5
CAPRIE (1996)67 Recent MI, CVA, or PAD (19 185, 28%, 62.5 years) Clopidogrel 75 mg once daily vs ASA 325 mg 1.9 y Ischemic stroke, MI, vascular death 8.7 (0.3 to 16.5), P=0.043 5.32
5.83
CHARISMA (2006)74 Clinically evident CAD or multiple risk factors (15 603, 29.8%, 64 years) Clopidogrel 75 mg+ASA 75 to 162 mg vs placebo+ASA 75 to 162 mg 28 m{dagger} Cardiovascular death, MI, CVA (RR, 0.93; 95% CI, 0.83 to 1.05; P=0.22) 7.0 6.8
7.3
MATCH (2004)75 Recent ischemic CVA or TIA (7599, 37%, 66.3 years) Clopidogrel 75 mg+ASA 75 mg once daily vs clopidogrel 75 mg+placebo 18 m Ischemic CVA, MI, vascular death, or rehospitalization for acute ischemia 6.4 (4.6 to 16.3), P=0.24 15.7
16.7
ACTIVE-W (2005)76 A fib and ≥1 stroke risk factor (6706, 23.5%, 70.2 years)
Clopidogrel 75 mg once daily and ASA 75 to 100 mg vs warfarin
1.28 y{dagger} Stroke, non–central nervous system systemic embolism, MI, and vascular mortality (RR, 1.44; 95% CI, 1.18 to 1.76; P=0.0003)
43.5 (increased risk)
5.64
3.93

OR indicates odds ration; RR, relative risk; RRR, relative risk reduction; and TIA, transient ischemic attack.
*Crude calculation from reported primary point event rate when not available in published results (95% CI provided when available).
{dagger}Median value.





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