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Table. Summary of trials (compiled from references 1-10)
DRUG/STUDY STUDY DESIGN ASPIRIN/HEPARIN DOSING RESULTS* ADVERSE REACTIONS
Abciximab            
ERIC
(11/91-11/92)		 0.25 mg/kg bolus, then 10 ?g/kg/min infusion up to 12 hours after event vs heparin placebo 325 mg aspirin plus 10,000-12,000 units heparin prior to angioplasty, continued until the end Frequency of composite clinical endpoint at 30 days of 12.8% with placebo vs 11.4% for bolus vs 8.3% for bolus plus infusion (P = 0.008 placebo vs bolus plus infusion). Increased bleeding risk
EPILOG
(2/95-12/95)		 0.25 mg/kg bolus, then 0.125 ?g/kg/min (maximum, 10 ?g/min) infusion for 12 hours vs heparin placebo 325 mg aspirin (2 hours prior) plus 100 units/kg bolus, then weight-adjusted hparin for low-dose and traditional arms (ACT 200-300 seconds) Interim analysis at 30 days revealed 5.2% incidence in composite endpoints in low-dose heparin group and 5.4% with standard-dose heparin vs 22.7% with placebo (P < 0.001). Decreased bleeding rate with adjusted-dose heparin arm
CAPTURE
(5/93-12/95)		 0.25 mg/kg bolus, then 10 ?g/kg/min infusion 18-24 hours before angioplasty and 1 hour after completion vs heparin placebo 50 mg aspirin (minimum) plus 100 units/kg heparin (10,000 units maximum), then heparin infusion (ACT 300 seconds) before randomization until 1 hour after angioplasty Study stopped after interim analysis of data showing 10.8% had primary endpoint in treatment group vs 16.4% with placebo (P = 0.0064); at 30 days it was 11.3% vs 15.9% for placebo (P = 0.012). Major bleeding complications in 3.8% of patients
EPISTENT
(7/96-9/97)		 0.25 mg/kg bolus, then 0.125 ?g/kg/min (maximum, 10 ?g/min) infusion for 12 hours vs heparin placebo 325 mg aspirin (2 hours prior) plus weight-adjusted heparin with or without ticlopidine 10.8% incidence in composite endpoints for stent plus placebo vs 5.3% for stent plus abciximab (P < 0.001) and 6.9% for angioplasty plus abciximab (P = 0.007). Bleeding rates similar among groups
Eptifibatide            
IMPACT
 90 ?g/kg bolus, then 1 ?g/kg/min infusion every 4 hours vs 90 ?g/kg bolus, then 1 ?g/kg/min infusion every 12 hours 325 mg aspirin plus 10,000 units heparin bolus, then adjusted-dose heparin to ACT > 300 seconds (started after vascular access established) 4.1% incidence in primary composite endpoint at 30 days for 12-hour group vs 9.6% for 4-hour group vs 12.2% for placebo (insignificant). Major bleeding incidence similar among all groups
IMPACT-II
(11/93-1/97)		 135 ?g/kg bolus, then 0.5 ?g/kg/min or 0.75 ?g/kg/min for 20-24 hours vs heparin placebo 325 mg aspirin plus 100 units/kg heparin bolus, then infusion (ACT 300-350 seconds) Composite endpoint reached by 11.4% in placebo group vs 9.9% in high-dose drug arm vs 9.2% for 4-hour group vs 12.2% for placebo (insignificant); rates maintained at 6 months. Major bleeding incidence similar among all groups
PURSUIT
(11/95-1/97)		 180 ?g/kg bolus, then 1.3 ?g/kg/min infusion vs 180 ?g/kg bolus, then 2 ?g/kg/min infusion for 72-96 hours Aspirin at discretion of investigator (could give ticlopidine) with or without heparin Composite endpoint reached by 15.7% in placebo group (? heparin) vs 14.2% in high-dose drug group at 30 days (P = 0.04). Of patients requiring revascularization within 72 hours (59.9% vs 59.0%): 16.7% placebo vs 11.6% drug (P + 0.01). Increased risk of bleeding and greater need for blood transfusions
Tirofiban            
PRISM
(4/94-10/96)		 Loading dose, 0.6 ?g/kg/min X 30 minutes, then 0.15 ?g/kg/min infusion for 47.5 hours vs heparin placebo 325 mg asprin with or without 5000 units heparin bolus, then 1000 units/hr infusion for 48 hours or infusion placebo; open-label therapy with heparin beginning at 48 hours if needed Composite endpoint reached by 15.9% in tirofiban group vs 17.1% in heparin group at 30 days (P = 0.34). Statistical significance reached at 48 hours but not maintained when infusion stopped: 3.8% vs 5.6% (P = 0.01). Infrequent major bleeding with no difference among groups
PRISM-PLUS
(11/94-9/96)		 Loading dose, 0.6 ?g/kg/min X 30 minutes, then 0.15 ?g/kg/min infusion for 47.5 hours or loading dose, 0.4 ?g/kg/min X 30 minutes, then 0.1 ?g/kg/min infusion plus adjusted-dose heparin vs adjusted-dose heprin placebo 325 mg aspirin with or without 5000 units heparin bolus, the 1000 units/hr infusion for 48 hours or infusion placebo for APTT twice control Composite endpoint reached by 22.3% with heparin alone vs 18.5% with tirofiban plus heparin (P - 0.03) at 30 days. Bleeding rate not increased with heparin use vs PRISM trial
RESTORE
(1/95-12/95)		 10 ?g/kg bolus, then 0.15 ?g/kg/min infusion for 36 hours vs heparin placebo 325 mg aspirin plus 150 units/kg heparin bolus (10,000 units maximum), then infusion (ACT 300-400 seconds) within 12 hours before procedure. Discontinued at end of procedure; sheath removed when ACT , 180 seconds 12.2% incidence in primary composite endpoint at 30 days vs 10.3% for placebo (P = 0.16). Insignificant increase in thrombocytopenia or major bleedings with tirofiban
              
*Composite endpoints for studies were generally identified as death from any cause, myocardial infarction, or refractory ischemia requiring intervention. Please refer to the specific study for actual study design. ACT indicates activated coagultion time; APTT, activated partial thromboplastin time.