Clinical trial NCT01498003: Tirofiban in Stenting for Long Coronary Lesion
Official title: Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: coronary disease
stents
thrombosis
myocardial infarction
prognosis
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 748
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age between 18y\~80y, with symptomatic coronary disease
* At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel

Exclusion Criteria:

* Aspirin or clopidogrel intolerance
* Lesions length less than 40mm, or overlapping stent length less than 40mm
* Bifurcation lesions need to be treated by two stents
* Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)
* Left ventricular ejection fraction less than 0.35
* Baseline estimated GFR less than 30
* Estimated life time less than one year
* Refuse to sign the informed consent

Primary outcomes:
measure: periprocedural infarction
timeFrame: 12h after procedure
Secondary outcomes:
measure: major bleeding
timeFrame: during hospitalization (up to 2 weeks)
measure: major adverse cardiac event
timeFrame: one year after procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: WeiFeng Shen, PhD
role: STUDY_CHAIR
References:
citation: Zhang Q, Wang XL, Liao ML, Hu J, Yang ZK, Ding FH, Zhang JS, Du R, Zhu TQ, Shen WF, Zhang RY. Periprocedural use of tirofiban in elective percutaneous coronary intervention for long coronary lesions in stable patients with overlapping drug-eluting stents--the PETITION study: a prospective, randomized, multicenter study. Catheter Cardiovasc Interv. 2015 Mar;85 Suppl 1:762-9. doi: 10.1002/ccd.25864.