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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00269893
First received: December 22, 2005
Last updated: June 1, 2015
Last verified: June 2015
  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
Angina, Unstable
Angioplasty, Transluminal, Percutaneous Coronary
Drug: Abciximab
Drug: Placebo
Phase 3

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


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). [ Time Frame: 30 days after angioplasty ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants With use of thrombolytic agent in catheterization lab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Time spent in catheterization lab [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of balloon Used inflations during angioplasty [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Number of Successful Angioplasty [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Reason for Specific Mortality [ Time Frame: Up to end of study (30 days after angioplasty) ] [ Designated as safety issue: No ]
  • Number of participants with late major clinical events [ Time Frame: 30 days after angioplasty up to 6 months after angioplasty ] [ Designated as safety issue: No ]
  • Number of Abrupt Closure [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Enrollment: 2038
Study Start Date: November 1991
Study Completion Date: November 1992
Primary Completion Date: November 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.
Drug: Placebo
Matching Placebo soulution either bolus or infusion.
Experimental: Abciximab and Placebo
Participants will receive 0.25 milligram per kilogram (mg/kg) of body weight of abciximab (c7E3 Fab) bolus injection followed by followed by placebo solution infusion up to 12 hours.
Drug: Abciximab
0.25 mg/kg of body weight of abciximab either bolus or infusion.
Other Name: c7E3 Fab
Drug: Placebo
Matching Placebo soulution either bolus or infusion.
Experimental: Abciximab
Participants will receive 0.25 mg/kg of body weight of abciximab bolus followed by abciximab (c7E3 Fab) infusion up to 12 hours.
Drug: Abciximab
0.25 mg/kg of body weight of abciximab either bolus or infusion.
Other Name: c7E3 Fab

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00269893     History of Changes
Other Study ID Numbers: CR006268, C0116T09
Study First Received: December 22, 2005
Last Updated: June 1, 2015
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:
Abciximab
Angina, unstable
Angioplasty, transluminal, Percutaneous coronary

Additional relevant MeSH terms:
Angina, Unstable
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Heart Diseases
Myocardial Ischemia
Pain
Signs and Symptoms
Vascular Diseases
Abciximab
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 03, 2015