The Effects of Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
Recruitment status was: Not yet recruiting
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of The Effects of a Single High Dose Bolus Tirofiban in Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention|
- The magnitude of platelet aggregation inhibition before randomization, 10 minutes (t=0) and 8 hours (t=8) post tirofiban administration using the Ultegra RPFA assay.
- The difference of flow cytometry and platelet monocyte aggregation between the two groups.
- The incidence of troponin T release 12 hours post PCI among the two groups.
- The difference in mean troponin T between the groups at 12 hours post PCI.
- Major adverse cardiac events (MACE) at 24 hours and 30 days post PCI.
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||December 2008|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00407771
|Amman, Jordan, 11152|
|Principal Investigator:||Imad A Alhaddad, MD||Jordan Cardiovascular Center|