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

NCT00271401 | Completed Phase 3

• 1 other identifier: CR006265
• Study Type: interventional
• Target: 2,399
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Angioplasty, Transluminal, Percutaneous Coronary

Keywords

Stents; Angioplasty, Transluminal, Percutaneous Coronary

Outcome Measures

Primary Outcomes (1)

• Number of Participants With any one of these: Deaths, Myocardial Infarctions, or Urgent Repeat Revascularizations

  Up to 30 days

Secondary Outcomes (1)

• Number of Particpants with Angiographic Outcome, Death or Myocardial Infraction and Cardiovascular Functional Status

  Up to 6 months

Study Arms (3)

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.

Other: Angioplasty; Drug: Abxicimab; Drug: Heparin

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).

Other: Intracoronary Stent; Drug: Abxicimab; Drug: Heparin

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).

Other: Intracoronary Stent; Drug: Heparin; Drug: Placebo

Interventions

Angioplasty OTHER

Angioplasty With Abciximab Plus Low-Dose Heparin

Intracoronary Stent OTHER

Intracoronary Stent With Placebo Plus Standard Dose Heparin; Intracoronary Stent With Reo Pro Plus Low Dose Heparin

Abxicimab DRUG

Angioplasty With Abciximab Plus Low-Dose Heparin; Intracoronary Stent With Reo Pro Plus Low Dose Heparin

Heparin DRUG

Angioplasty With Abciximab Plus Low-Dose Heparin; Intracoronary Stent With Placebo Plus Standard Dose Heparin; Intracoronary Stent With Reo Pro Plus Low Dose Heparin

Placebo DRUG

Intracoronary Stent With Placebo Plus Standard Dose Heparin

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Related Publications (2)

• 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.

  PMID: 10636365 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.

  PMID: 9672272 RESULT

MeSH Terms

Interventions

Angioplasty; Heparin

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 2, 2006
• Study Start: July 1, 1996
• Primary Completion: September 1, 1997
• Study Completion: September 1, 1997
• Last Updated: May 25, 2015

Record last verified: 2015-05