The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention

• Status: Unknown status
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

• The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg) clopidogrel.

• About 44 people will be in the study. The study duration is a single hospitalization period during which the angioplasty will be performed in addition to a 30-day post hospitalization follow-up period.

• Patients taking part in the study will be assigned by chance into two groups.

• Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started immediately after insertion of the sheath.

• Group 2: patients will be treated with equivalent placebo

All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled intervention.

All patients will have platelet function analyses at baseline and following treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jordan Hospital
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Tirofiban

Criteria

Inclusion Criteria:

• Diabetic patients with coronary artery disease undergoing elective percutaneous coronary intervention

Exclusion Criteria:

• Ongoing ST-segment elevation myocardial infarction (MI)

• Administration of abciximab during the previous two weeks

• Serum creatinine more than 2.5 mg/dl (221 micro-mol/L)

• Ongoing bleeding or bleeding diathesis

• Previous stroke in the last six months

• Major surgery within the previous six weeks

• Platelet count <100.000 per cubic mm

• Subjects who received low-molecular-weight heparin, tirofiban, or eptifibatide within the 10 hours prior to randomization

• Subjects on oral anticoagulation medication (coumarin derivatives) within the last 7 days unless PT-INR <1.5 times the control