Clinical trial NCT00269893: A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty
Official title: A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angina, Unstable
Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Abciximab
Angina, unstable
Angioplasty, transluminal, Percutaneous coronary
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 2038
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of abciximab (an anti-platelet therapy) versus placebo in patients undergoing high risk coronary angioplasty.

Detailed description: This is a randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of abciximab, an anti-platelet therapy, in patients undergoing high risk coronary angioplasty. The primary outcomes of the study include any of the following: the number of deaths from any cause, or myocardial infarctions and recurrent ischemic events requiring urgent intervention (e.g., repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).

Patients receive an abciximab bolus, abciximab bolus plus infusion, or placebo.

Eligibility criteria: Inclusion Criteria:

* Patients referred for elective or urgent coronary balloon angioplasty or atherectomy with an FDA-approved device in one of the following settings: unstable angina or non-Q wave myocardial infarction, acute Q-wave myocardial infarction, or high-risk clinical/morphological characteristics

Exclusion Criteria:

* Patients with a history of hemorrhagic diathesis - Having had major surgery or clinically significant gastrointestinal or genitourinary bleeding within 6 weeks of study enrollment
* Having had a stroke within 2 years prior to enrollment or any stroke with significant residual neurological deficit
* Having occlusion of the left main coronary artery greater than 50% or a history of vasculitis
* Treated with oral anticoagulants within 7 days (unless prothrombin time is =\< 1.2 times control) or intravenous dextran (before or planned for during the treatment angioplasty)

Primary outcomes:
measure: Any of the following within 30 days: Death from any cause; Myocardial infarction; Recurrent ischemic event requiring urgent intervention (repeat angioplasty, coronary artery bypass surgery, intracoronary stent placement, or intra-aortic balloon pump).
timeFrame: 30 days after angioplasty
Secondary outcomes:
measure: Number of participants With use of thrombolytic agent in catheterization lab
timeFrame: Day 1
measure: Time spent in catheterization lab
timeFrame: Day 1
measure: Number of balloon Used inflations during angioplasty
timeFrame: Day 1
measure: Number of Successful Angioplasty
timeFrame: Day 1
measure: Reason for Specific Mortality
timeFrame: Up to end of study (30 days after angioplasty)
measure: Number of participants with late major clinical events
timeFrame: 30 days after angioplasty up to 6 months after angioplasty
measure: Number of Abrupt Closure
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med. 1994 Apr 7;330(14):956-61. doi: 10.1056/NEJM199404073301402.
citation: Topol EJ, Ferguson JJ, Weisman HF, Tcheng JE, Ellis SG, Kleiman NS, Ivanhoe RJ, Wang AL, Miller DP, Anderson KM, Califf RM. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin beta3 blockade with percutaneous coronary intervention. EPIC Investigator Group. Evaluation of Platelet IIb/IIIa Inhibition for Prevention of Ischemic Complication. JAMA. 1997 Aug 13;278(6):479-84. doi: 10.1001/jama.278.6.479.