NCT00398463

Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance

Tailoring Treatment With Tirofiban in Patients Showing Resistance to Aspirin and/or Resistance to Clopidogrel

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 263 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.

Detailed description

This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel. This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.

Conditions

• Angioplasty, Transluminal, Percutaneous Coronary

Interventions

Type	Name	Description
DRUG	Tirofiban	Tirofiban infusion given as high bolus dose plus standard 14-24 hour infusion
DRUG	Placebo	Saline infusion will be administered for 14-24 hours

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-07-01
• Completion: 2011-05-01
• First posted: 2006-11-10
• Last updated: 2011-07-01

Locations

1 site across 1 country: Italy