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

NCT00269893 | Completed Phase 3 DMC

• 2 other identifiers: CR006268C0116T09
• Study Type: interventional
• Target: 2,038
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Angina, Unstable; Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Abciximab; Angina, unstable; Angioplasty, transluminal, Percutaneous coronary

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Number of participants With use of thrombolytic agent in catheterization lab

  Day 1

• Time spent in catheterization lab

  Day 1

• Number of balloon Used inflations during angioplasty

  Day 1

• Number of Successful Angioplasty

  Day 1

• Reason for Specific Mortality

  Up to end of study (30 days after angioplasty)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo solution bolus followed by matching placebo solution infusion up to 12 hours.

Drug: Placebo

Abciximab and Placebo

EXPERIMENTAL

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; Drug: Placebo

Abciximab

EXPERIMENTAL

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

Interventions

Abciximab DRUG

0.25 mg/kg of body weight of abciximab either bolus or infusion.

Also known as: c7E3 Fab

Abciximab; Abciximab and Placebo

Placebo DRUG

Matching Placebo soulution either bolus or infusion.

Abciximab and Placebo; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (2)

• 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.

  PMID: 8121459 RESULT

• 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.

  PMID: 9256222 RESULT

MeSH Terms

Conditions

Angina, Unstable

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Start: November 1, 1991
• Primary Completion: November 1, 1992
• Study Completion: November 1, 1992
• Last Updated: June 2, 2015

Record last verified: 2015-06