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OpenTrials
Completed

NCT Number: NCT00269880

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.

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.

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Key information

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This is a randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of abciximab, an anti-platelet therapy, in combination with two different heparin regimens in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: abciximab/low-dose weight-adjusted heparin, abciximab/standard-dose weight-adjusted heparin, or placebo/standard-dose weight-adjusted heparin. The primary outcomes of the study include the number of deaths, myocardial infarctions, or repeat revascularizations within 6 months, and the number of deaths, myocardial infarctions, or severe myocardial ischemia leading to urgent repeat percutaneous coronary intervention or urgent coronary artery bypass surgery within 30 days. Please see attached results.

Abciximab bolus plus 12-hour infusion with standard-dose weight-adjusted heparin; Abciximab bolus plus 12-hour infusion with low-dose weight-adjusted heparin; Placebo bolus plus 12-hour infusion with standard-dose weight-adjusted heparin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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%

Treatment and study plan

Placebo

Drug

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

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

Drug

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

Primary outcomes

  1. Death, myocardial infarction, or repeat revascularization within 6 months

    Time frame: up to 6 months

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

    Time frame: 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

    Time frame: up to 6 months

Sponsors and collaborators

Lead sponsor

Centocor, Inc.

Industry

Registry information

Official study title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Clinical Outcomes Following Percutaneous Coronary Intervention in Patients Treated With an Abciximab Bolus Plus 12-Hour Infusion Given With Either Standard-Dose Weight-Adjusted Heparin or Low-Dose Weight-Adjusted Heparin

Important dates

Study start
1995
Primary completion
1995
Study completion
1995
First posted
Dec 26, 2005
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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