DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Centocor, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary

Intervention: Abciximab (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Centocor, Inc.

Official(s) and/or principal investigator(s):
Centocor, Inc. Clinical Trial, Study Director, Affiliation: Centocor, Inc.

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.

Clinical Details

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

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

Primary outcome: 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:

Number of participants With use of thrombolytic agent in catheterization lab

Time spent in catheterization lab

Number of balloon Used inflations during angioplasty

Number of Successful Angioplasty

Reason for Specific Mortality

Number of participants with late major clinical events

Number of Abrupt Closure

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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)

Locations and Contacts

Additional Information

Starting date: November 1991
Last updated: June 1, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017