Clinical Trials Directory

Trials / Completed

CompletedNCT01498003

Tirofiban in Stenting for Long Coronary Lesion

Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
748 (actual)
Sponsor
Shanghai Jiao Tong University School of Medicine · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.

Detailed description

According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report\[International Journal of Cardiology 2009;134: 231-237\], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.

Conditions

Interventions

TypeNameDescription
DRUGtirofiban10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
DRUGnormal saline solutionsame use as tirofiban

Timeline

Start date
2011-11-01
Primary completion
2014-06-01
Completion
2014-06-01
First posted
2011-12-23
Last updated
2015-07-14

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT01498003. Inclusion in this directory is not an endorsement.