Coronary Artery Disease
Conditions
Keywords
coronary disease, stents, thrombosis, myocardial infarction, prognosis
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.
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
DRUGtirofiban
10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
DRUGnormal saline solution
same use as tirofiban
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| periprocedural infarction | 12h after procedure | definition of periprocedural MI is a CK elevation \>3 times the upper limit of normal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed