Tirofiban in Stenting for Long Coronary Lesion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

748 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

normal saline solution

Intervention Type DRUG

same use as tirofiban

Tirofiban group

after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion

Group Type EXPERIMENTAL

tirofiban

Intervention Type DRUG

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

Interventions

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tirofiban

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

Intervention Type DRUG

normal saline solution

same use as tirofiban

Intervention Type DRUG

Other Intervention Names

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Xinweining, Grand Pharmaceutical Group, Wuhan, China

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No