Tirofiban in Stenting for Long Coronary Lesion

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: tirofiban
* Drug: normal saline solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>normal saline was applied to those randomized to control group, with same use as tirofiban | Drug: normal saline solution<br>* same use as tirofiban<br>|
| Experimental: Tirofiban group<br>after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion | Drug: tirofiban<br>* 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h<br>* Other names: Xinweining, Grand Pharmaceutical Group, Wuhan, China;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| periprocedural infarction | definition of periprocedural MI is a CK elevation >3 times the upper limit of normal. | 12h after procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary disease, stents, thrombosis, myocardial infarction, prognosis