A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab

A Multicenter, Randomized Trial Evaluating 30-day and 6-month Clinical Outcomes With Three Different Treatment Strategies (Coronary Angioplasty + Abciximab, Intracoronary Stent + Abciximab, and Intracoronary Stent + Placebo) in Patients Undergoing Percutaneous Coronary Intervention

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271401

Enrollment

2399

Registered

2006-01-02

Start date

1996-07-31

Completion date

1997-09-30

Last updated

2015-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Stents, Angioplasty, Transluminal, Percutaneous Coronary

Brief summary

The purpose of this study is to compare the effectiveness and safety of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and effectiveness of intracoronary stenting with or without abciximab, an anti-platelet therapy, and conventional coronary angioplasty with abciximab in patients undergoing percutaneous coronary intervention. Patients will be randomly assigned to one of three treatment groups: coronary angioplasty plus abciximab, intracoronary stent plus abciximab, or intracoronary stent plus placebo. The primary measures of effectiveness will be a 30-day composite, clinical outcome as determined by the number of deaths, myocardial infarctions, or urgent repeat revascularizations. Please see attached results. Patients will receive one of three different treatments: Coronary angioplasty plus abciximab; Intracoronary stent plus abciximab; or Intracoronary stent plus placebo.

Interventions

OTHERAngioplasty

OTHERIntracoronary Stent

DRUGAbxicimab

DRUGHeparin

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients referred for elective or urgent percutaneous coronary intervention * Who are suitable candidates for either conventional angioplasty or primary intracoronary stent implantation * Having a target artery (native or graft) stenosis of \>= 60% (visual estimation)

Exclusion criteria

* Patients with acute ST-segment elevation myocardial infarction within the previous 12 hours * With a planned staged procedure or having an unprotected left main coronary artery stenosis \> 50% * With active internal bleeding, having a condition that may increase the risk of bleeding, or receiving ongoing treatment with an oral anticoagulant at the time of study entry * Having had a percutaneous coronary intervention within the previous 3 months or prior intracoronary stent placement in a target vessel * Having hypertension with systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 100 mm Hg at the time of study entry, or a platelet count \< 100,000/μL at baseline

Design outcomes

Primary

Measure	Time frame
Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations	Up to 30 days

Secondary

Measure	Time frame
Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status	Up to 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026