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
| Type | Name | Description |
|---|---|---|
| DRUG | tirofiban | 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h |
| DRUG | normal saline solution | same 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.