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

NCT01863134 | Completed Phase 4 Results DMC

• 1 other identifier: 2 P05C 023 27
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 6

Brief Summary

1. 1.INTRODUCTION
2. 2.STUDY RATIONALE

Conditions

Non ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac and Cerebrovascular Events (MACCE)

  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

  Up to 12 month

Study Arms (2)

Eptifibatide

EXPERIMENTAL

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 orally daily until the day of the procedure) and enoxaparin (1mg/kg subcutaneous - with the last dose 12 hours before surgery).

Drug: Eptifibatide

Placebo

PLACEBO COMPARATOR

Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg orally daily until the day of the procedure) and enoxaparin (1mg/kg subcutaneous - with the last dose 12 hours before surgery).

Drug: Placebo

Interventions

Eptifibatide DRUG

Also known as: In the active treatment arm patients were additionally treated with eptifibatide (Integrillin; 180µg/kg of body weight) at an infusion rate 2 µg/kg/min

Eptifibatide

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must have a typical anginal pain lasting at least 20 min., but no longer than 24h.
• ECG confirming ischaemia
• ST segment depression \>= 1,0 mm in at least 2 leads, or,
• negative T waves \>= 2,0 mm in at least 2 leads.
• Positive troponin I (TnI).
• Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent and/or parent or legal guardian must have signed a written informed consent.
• Subjects must be ≥ 21 year of age, of either sex and any race.
• Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed IUD - intrauterine device, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).

You may not qualify if:

• Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to record concomitant medications and adverse events.
• Women who are pregnant or nursing.
• Subjects who have not observed the designated washout periods for any of the prohibited medications.
• Subjects who have used any investigational product within 30 days prior to enrollment.
• Subjects who have the following clinical conditions are excluded:
• Patients with:
• Angina lasting longer than 24h.
• ST segment elevation - Pardy wave
• age over 75 years
• history of revascularization procedure during last 6 months (PTCA, CABG)
• chronic heart failure (NYHA III or IV) during pre-hospitalization period
• history of bleeding from gastrointestinal tract or genitourinary system during last 30 days
• history of intracranial lesions or stroke
• history of major surgery or trauma during last 6 weeks
• history of hemorrhagic diathesis

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (6)

Albert Einstein College of Medicine

New York, New York, United States

Location

First Department of Cardiac Surgery, Medical University of Silesia

Katowice, Silesian Voivodeship, 40-635, Poland

Location

Center for Cardiovascular Research and Development, American Heart of Poland

Katowice, Poland

Location

Department of Internal Medicine and Clinical Pharmacology

Katowice, Poland

Location

First Department of Cardiology, Medical University of Silesia

Katowice, Poland

Location

Division of Molecular Biology and Clinical Genetics, Jagiellonian University Medical College

Krakow, Poland

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Eptifibatide; Weights and Measures

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Investigative Techniques

Results Point of Contact

• Title: Miroslaw Wilczynski
• Organization: First Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland

miroslaw.wilczynski@cardiosurg.pl

+48 32 20 24 025

Study Officials

• Miroslaw Wilczynski, MD, PhD

  Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 18, 2013
• First Posted: May 27, 2013
• Study Start: January 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 31, 2013
• Results First Posted: October 31, 2013

Record last verified: 2013-08

Locations

US (1); PL (5)