Tirofiban in Stenting for Long Coronary Lesion

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

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.

Interventions

  • Drug: tirofiban
    • 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
  • Drug: normal saline solution
    • same use as tirofiban

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • periprocedural infarction
    • Time Frame: 12h after procedure
    • definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Jiao Tong University School of Medicine
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhang Qi, MD, Vice Director of Cath. Lab – Shanghai Jiao Tong University School of Medicine
  • Overall Official(s)
    • WeiFeng Shen, PhD, Study Chair, Ruijin Hospital

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