Status:
UNKNOWN
Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
Lead Sponsor:
Second Hospital of Jilin University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 bifurcat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT02294994
Start Date
November 1 2014
End Date
December 1 2016
Last Update
December 2 2014
Active Locations (1)
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1
The sencond hospital of Jilin University
Changchun, Jilin, China, 130041