Coronary Artery Disease
Conditions
Brief summary
The aim of the study is to investigate the efficacy and safety different dose of GPIIb/IIIa inhibitor (tirofiban) in interventional treatment of complex coronary artery disease ,which include bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score\>26,chronic total occlusion disease. The primary endpoint is all-cause mortality. Secondary endpoints are incidence of major bleeding and the rate of site access complication.
Interventions
DRUGtirofiban
Sponsors
Second Hospital of Jilin University
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
* Patients were recruited from those undergoing PCI with a planned placement of an intracoronary stent * Including patients with unstable angina pectoris, acute coronary syndrome or NSTEMI * Experienced ischaemic pain at rest * Lasting 10 minutes and occurring within 7 days before enrollment * As well as one of the following: ECG changes: New or presumably new ST-segment depression greater than or equal to 0.1 mV (1 mm), or transient (\< 30 minutes) ST-segment elevation greater than or equal to 0.1 mV (1 mm) in at least 2 contiguous leads -Abnormal cardiac enzymes within the 24 hours before enrollment, defined as elevated Troponin I defined as elevated Troponin I (above the normal reference - * High-risk angiographic features :lesion/anatomy related bifurcation lesion, left main lesion, multiple vessel disease, intracoronary thrombus, SYNTAX score \> 26 and chronic total occlusion disease.
Exclusion criteria
* Increased bleeding risk: ischaemic stroke within the last year or any previous haemorrhagic stroke, tumour or intracranial aneurysm; * Recent (\<1 month) trauma or major surgery (including bypass surgery); * Active bleeding * Unexplained clinically significant bleeding, thrombocytopenia (platelet count \< 100 x 109/L) or history of thrombocytopenia with GP IIb/IIIa, heparin or enoxaparin therapy * Angina from secondary causes such as severe uncontrolled hypertension (systolic blood pressure \> 180 mm Hg despite treatment) * Valvular disease, congenital heart disease, hypertrophic cardiomyopathy, - Thrombolytic therapy within preceding 24 hours * Receiving antiIIb/IIIa therapy * Creatinine clearance of \<30 mL/min
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net Adverse Clinical Events | 30 days | A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical events | 1 year | a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings |
| any bleedings (BARC class) | 30 days | including all BARC class (class 1-5) |
| Major adverse cardiac and cerebral events (MACCE) | 30 days and 1 year | a composite of all cause death, reinfarction, target vessel revascularization or stroke |
| stent thrombosis | 30 days and 1 year | by ARC definition |
Countries
China
Contacts
Primary ContactLiu Bin, M.D.
Outcome results
None listed