Clinical trial NCT00271401: A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Angioplasty, Transluminal, Percutaneous Coronary
Keywords: Stents
Angioplasty, Transluminal, Percutaneous Coronary
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-02
Enrollment: 2399
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations
timeFrame: Up to 30 days
Secondary outcomes:
measure: Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Topol EJ, Mark DB, Lincoff AM, Cohen E, Burton J, Kleiman N, Talley D, Sapp S, Booth J, Cabot CF, Anderson KM, Califf RM. Outcomes at 1 year and economic implications of platelet glycoprotein IIb/IIIa blockade in patients undergoing coronary stenting: results from a multicentre randomised trial. EPISTENT Investigators. Evaluation of Platelet IIb/IIIa Inhibitor for Stenting. Lancet. 1999 Dec 11;354(9195):2019-24. doi: 10.1016/s0140-6736(99)10018-7.
citation: EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet. 1998 Jul 11;352(9122):87-92. doi: 10.1016/s0140-6736(98)06113-3.