Trial Outcomes & Findings for Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up (NCT NCT01863134)

NCT ID: NCT01863134

Last Updated: 2013-10-31

Results Overview

MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 140 participants
• Primary outcome timeframe: Up to 12 month
• Results posted on: 2013-10-31

Participant Flow

Four clinical centers located within a radius of 50km of the reference center were selected for the study. From 2005 to 2010 a total of 140 patients presenting with NSTE-ACS not eligible for PCI were enrolled to the study. All CABG procedures were performed at 1st Department of Cardiac Surgery, Silesian Medical University in Katowice.

Participant milestones

Measure	Eptifibatide Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).	Placebo Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
Overall Study STARTED	72	68
Overall Study COMPLETED	72	68
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Effects of Eptifibatide Administration in High Risk Patients Presenting With Non-ST Segment Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Urgent Coronary Artery Bypass Graft Surgery in Short- and Long-Term Follow-up

Baseline characteristics by cohort

Measure	Placebo/Control Group n=68 Participants In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.	Eptifibatide n=72 Participants In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.	Total n=140 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants	61 Participants n=7 Participants	119 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age Continuous	63.60 years STANDARD_DEVIATION 8.32 • n=5 Participants	62.47 years STANDARD_DEVIATION 10.41 • n=7 Participants	63.01 years STANDARD_DEVIATION 9.39 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Region of Enrollment Poland	68 participants n=5 Participants	72 participants n=7 Participants	140 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 12 month

MACCE was defined as combined death, nonfatal myocardial infarction, cerebrovascular event (stroke) and the need for re-hospitalization due to recurrent ischemia up to 12 months follow-up

Outcome measures

Measure	Placebo n=68 Participants Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).	Eptifibatide n=72 Participants Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	35.3 Percentage of study group	13.8 Percentage of study group

Adverse Events

Eptifibatide

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eptifibatide n=72 participants at risk Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).	Placebo n=68 participants at risk Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
General disorders Death up to 12 Months	2.8% 2/72 • Number of events 2 • 12 Months Death up to 12 Months	10.3% 7/68 • Number of events 7 • 12 Months Death up to 12 Months

Other adverse events

Measure	Eptifibatide n=72 participants at risk Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).	Placebo n=68 participants at risk Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
Infections and infestations Pulmonary infection	4.2% 3/72 • Number of events 3 • 12 Months Death up to 12 Months	7.4% 5/68 • Number of events 5 • 12 Months Death up to 12 Months
Nervous system disorders Delirium	0.00% 0/72 • 12 Months Death up to 12 Months	5.9% 4/68 • Number of events 4 • 12 Months Death up to 12 Months

Additional Information

Miroslaw Wilczynski

First Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland

Phone: +48 32 20 24 025

Email: miroslaw.wilczynski@cardiosurg.pl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place