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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angioplasty With Abciximab Plus Low-Dose Heparin | Experimental | 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. |
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| Intracoronary Stent With Reo Pro Plus Low Dose Heparin | Experimental | 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). |
|
| Intracoronary Stent With Placebo Plus Standard Dose Heparin | Placebo Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angioplasty | Other |
| ||
| Intracoronary Stent |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations | Up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10636365 | Result | 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. | |
| 9672272 |
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| Other |
|
| Abxicimab | Drug |
|
| Heparin | Drug |
|
| Placebo | Drug |
|
| Result |
| 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. |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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