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

Angina, Unstable Clinical Trial

Official title:

A Phase III Double-Blind, Placebo-Controlled Multicenter Study of Abciximab In Patients Undergoing High Risk Coronary Angioplasty (EPIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269893
• Other study ID #: CR006268
• Secondary ID: C0116T09
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: June 1, 2015
• Start date: November 1991
• Est. completion date: November 1992

Study information

• Verified date: June 2015
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2038
• Est. completion date: November 1992
• Est. primary completion date: November 1992
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Angioplasty, Transluminal, Percutaneous Coronary

Intervention

Drug:
• Abciximab
0.25 mg/kg of body weight of abciximab either bolus or infusion.
• Placebo
Matching Placebo soulution either bolus or infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (2)

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 coron — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		30 days after angioplasty	No
Secondary	Number of participants With use of thrombolytic agent in catheterization lab		Day 1	No
Secondary	Time spent in catheterization lab		Day 1	No
Secondary	Number of balloon Used inflations during angioplasty		Day 1	No
Secondary	Number of Successful Angioplasty		Day 1	No
Secondary	Reason for Specific Mortality		Up to end of study (30 days after angioplasty)	No
Secondary	Number of participants with late major clinical events		30 days after angioplasty up to 6 months after angioplasty	No
Secondary	Number of Abrupt Closure		Day 1	No