A Study Comparing the Efficacy and Safety of Intracoronary Stenting With or Without Abciximab, an Anti-Platelet Therapy, and Conventional Coronary Angioplasty With Abciximab
|ClinicalTrials.gov Identifier: NCT00271401|
Recruitment Status : Completed
First Posted : January 2, 2006
Last Update Posted : May 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Angioplasty, Transluminal, Percutaneous Coronary||Other: Angioplasty Other: Intracoronary Stent Drug: Abxicimab Drug: Heparin Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2399 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||July 1996|
|Primary Completion Date :||September 1997|
|Study Completion Date :||September 1997|
Experimental: Angioplasty With Abciximab Plus Low-Dose Heparin
Participants will receive conventional angioplasty/atherectomy along with bolus abciximab 0.25 milligram per kilogram (mg/kg) of body weight followed by a 0.125 microgram per kilogram per minute (mcg/kg/minute) infusion for 12 hours plus 7 unit per kilogram per hour (U/kg/hr) continuous infusion of heparin.
|Other: Angioplasty Drug: Abxicimab Drug: Heparin|
Experimental: Intracoronary Stent With Reo Pro Plus Low Dose Heparin
Participants will receive intracoronary stent along with receive bolus abciximab 0.25 mg/kg of body weight followed by a 0.125 mcg/kg/minute infusion for 12 hours plus 7 U/kg/hr continuous infusion of heparin (low dose).
|Other: Intracoronary Stent Drug: Abxicimab Drug: Heparin|
Placebo Comparator: Intracoronary Stent With Placebo Plus Standard Dose Heparin
Participants will receive intracoronary stent along with bolus placebo followed by placebo infusion for 12 hours plus 10 U/kg/hr continuous infusion of heparin (standard dose).
|Other: Intracoronary Stent Drug: Heparin Drug: Placebo|
- Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations [ Time Frame: Up to 30 days ]
- Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status [ Time Frame: Up to 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271401
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|