Tirofiban in Stenting for Long Coronary Lesion

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: normal saline solution; Drug: tirofiban

• Registration Number: NCT01498003
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-12-11
• Study First Submitted QC: 2011-12-20
• Study First Posted: 2011-12-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-13
• Last Update Posted: 2015-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 748

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	normal saline solution	normal saline was applied to those randomized to control group, with same use as tirofiban
Tirofiban group	tirofiban	after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion

Primary Outcome Measures

Name	Time	Method
periprocedural infarction	12h after procedure	definition of periprocedural MI is a CK elevation \>3 times the upper limit of normal.

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac event	one year after procedure	major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge
major bleeding	during hospitalization (up to 2 weeks)	The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition

Trial Locations

Locations (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China