A Study Comparing the Efficacy and Safety of Abciximab, an Anti-Platelet Therapy, in Combination With Two Different Heparin Regimens in Patients Undergoing Percutaneous Coronary Intervention.

NCT00269880 | Completed Phase 3

• 1 other identifier: CR006262
• Study Type: interventional
• Target: 2,792
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the safety and effectiveness of abciximab, an anti-platelet therapy, versus placebo in patients undergoing percutaneous coronary intervention when administered in combination with two different heparin regimens. Please see attached results.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Angioplasty, Transluminal, Percutaneous coronary

Outcome Measures

Primary Outcomes (2)

• Death, myocardial infarction, or repeat revascularization within 6 months

  up to 6 months

• Death, myocardial infarction, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days

  Up to 30 Days

Secondary Outcomes (1)

• Angiographic outcome; death, MI or target vessel revascularization within 6 months; death or MI within 6 months; health economic analyses

  up to 6 months

Study Arms (3)

Placebo and Standard Dose of Heparin

PLACEBO COMPARATOR

Participants will receive bolus placebo followed by 12-hour infusion of placebo and bolus heparin at a dose of 100 units per kilogram of body weight.

Drug: Placebo; Drug: Heparin

Abciximab and Low Dose of Heparin

ACTIVE COMPARATOR

Participants will receive bolus abciximab at a dose of 0.25 milligram per kilogram (mg/kg) of body weight followed by 12-hour infusion of 0.125 microgram per kilogram per minute (mcg/kg/min) and bolus heparin at a dose of 70 units per kilogram of body weight.

Drug: Heparin; Drug: Abciximab

Abciximab and Standard Dose Heparin

ACTIVE COMPARATOR

Participants will receive bolus abciximab at a dose of 0.25 mg/kg of body weight followed by 12-hour infusion of 0.125 mcg/kg/min and bolus heparin at a dose of 100 units per kilogram of body weight.

Drug: Heparin; Drug: Abciximab

Interventions

Placebo DRUG

Placebo is administered as bolus or 12 hour infusion prior to index percutaneous coronary intervention.

Placebo and Standard Dose of Heparin

Heparin DRUG

Heparin is administered as either high dose (100 units/kg of body weight) or low dose (70 units/kg of body weight) boluses.

Abciximab and Low Dose of Heparin; Abciximab and Standard Dose Heparin; Placebo and Standard Dose of Heparin

Abciximab DRUG

Abciximab is administered as bolus followed by 12 hour infusion prior to index percutaneous coronary intervention.

Abciximab and Low Dose of Heparin; Abciximab and Standard Dose Heparin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for elective or urgent percutaneous coronary intervention with an FDA-approved device
• Having a target artery (native or graft) stenosis of 60% by visual estimation

You may not qualify if:

• Patients with unstable angina/non-Q-wave myocardial infarction meeting EPIC criteria within the previous 24 hours, or with acute Q-wave myocardial infarction meeting EPIC criteria with onset of chest pain within previous 24 hours
• With active internal bleeding, having a condition that may increase the risk of bleeding, or currently receiving administration of oral anticoagulants at the time of study entry
• With confirmed hypertension with systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg
• Having had a percutaneous coronary intervention within the previous 3 months
• Having an unprotected left main coronary artery stenosis \> 50%

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (3)

• Lincoff AM, Mark DB, Tcheng JE, Califf RM, Bala MV, Anderson KM, Davidson-Ray L, Knight JD, Cabot CF, Topol EJ. Economic assessment of platelet glycoprotein IIb/IIIa receptor blockade with abciximab and low-dose heparin during percutaneous coronary revascularization: results from the EPILOG randomized trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade. Circulation. 2000 Dec 12;102(24):2923-9. doi: 10.1161/01.cir.102.24.2923.

  PMID: 11113041 RESULT

• Lincoff AM, Tcheng JE, Califf RM, Kereiakes DJ, Kelly TA, Timmis GC, Kleiman NS, Booth JE, Balog C, Cabot CF, Anderson KM, Weisman HF, Topol EJ. Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: one-year outcome in the EPILOG trial. Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade. Circulation. 1999 Apr 20;99(15):1951-8. doi: 10.1161/01.cir.99.15.1951.

  PMID: 10208997 RESULT

• EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med. 1997 Jun 12;336(24):1689-96. doi: 10.1056/NEJM199706123362401.

  PMID: 9182212 RESULT

Related Links

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MeSH Terms

Interventions

Heparin; Abciximab

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: February 1, 1995
• Primary Completion: December 1, 1995
• Study Completion: December 1, 1995
• Last Updated: May 25, 2015

Record last verified: 2015-05