Tirofiban in Stenting for Long Coronary Lesion

Coronary Artery Disease Clinical Trial

— PETITION  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498003
• Other study ID #: 20111211
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2011
• Last updated: July 13, 2015
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: July 2015
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 748
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periprocedural infarction	definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.	12h after procedure	No
Secondary	major bleeding	The safety outcome of major bleeding according to the Thrombolysis in Myocardial Infarction (TIMI) definition	during hospitalization (up to 2 weeks)	Yes
Secondary	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	No

External Links

•   published results