A Study Evaluating the Efficacy and Safety of Abciximab, an Anti-platelet Therapy, in Patients Undergoing High-risk Coronary Angioplasty - Full Text View

Purpose

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.

Condition	Intervention	Phase
Angioplasty, Transluminal, Percutaneous Coronary	Drug: abciximab bolus, abciximab bolus plus infusion, or placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

Abrupt closure; Use of thrombolytic agents in the catheterization lab; Time in catheterization lab; Number of balloon inflations during angioplasty; Angioplasty success; Cause specific mortality

Estimated Enrollment:

2100

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269893

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Publications:

[No authors listed] Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. The EPIC Investigation. N Engl J Med. 1994 Apr 7;330(14):956-61.

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.

ClinicalTrials.gov Identifier:	NCT00269893 History of Changes
Other Study ID Numbers:	CR006268
Study First Received:	December 22, 2005
Last Updated:	April 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Centocor, Inc.:

abciximab bolus, abciximab bolus plus infusion, or placebo

Additional relevant MeSH terms:

Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on June 17, 2013