Status:
COMPLETED
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
Lead Sponsor:
Medical University of Silesia
Conditions:
Non ST Elevation Myocardial Infarction
Eligibility:
All Genders
21-75 years
Phase:
PHASE4
Brief Summary
1. INTRODUCTION Through last couple of years the number of patients treated for acute coronary event without persistent ST segment elevation in ECG has been growing. This is probably an effect...
Eligibility Criteria
Inclusion
- 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).
- Subjects must be free of any clinically significant disease that would interfere with study evaluations (see exclusion criteria).
- Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to record concomitant medications and adverse events.
Exclusion
- 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
- thrombocytopenia \< 100 000/mm3
- anticoagulant therapy with INR\>2,0
- significant hepatic failure
- significant renal failure with serum creatinine\>2,0 mg%
- elevated blood pressure: SBP\>200mmHg and/or DBP\>110mmHg despite the antihypertensive treatment
- allergy to drugs or any therapeutic agent
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01863134
Start Date
January 1 2005
End Date
December 1 2010
Last Update
October 31 2013
Active Locations (6)
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1
Albert Einstein College of Medicine
New York, New York, United States
2
First Department of Cardiac Surgery, Medical University of Silesia
Katowice, Silesian Voivodeship, Poland, 40-635
3
Center for Cardiovascular Research and Development, American Heart of Poland
Katowice, Poland
4
Department of Internal Medicine and Clinical Pharmacology
Katowice, Poland