PETITION: Tirofiban in Stenting for Long Coronary Lesion

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01498003

Collaborator

(none)

748

Enrollment

Location

Arms

Duration (Months)

24.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: tirofiban Drug: normal saline solution	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

748 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group normal saline was applied to those randomized to control group, with same use as tirofiban	Drug: normal saline solution 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	Drug: tirofiban 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h Other Names: Xinweining, Grand Pharmaceutical Group, Wuhan, China

Arm

Intervention/Treatment

Placebo Comparator: Control group

normal saline was applied to those randomized to control group, with same use as tirofiban

Drug: normal saline solution

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

Drug: tirofiban

10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h

Other Names:

Xinweining, Grand Pharmaceutical Group, Wuhan, China

Outcome Measures

Primary Outcome Measures

periprocedural infarction [12h after procedure]
definition of periprocedural MI is a CK elevation >3 times the upper limit of normal.

Secondary Outcome Measures

major bleeding [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 [one year after procedure]
major adverse cardiac event (MACE) includes cardiac death, target vessel revascularization, and re-occurrence of myocardial infarction after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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