Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Randomized Controlled Clinical Study to Compare the Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02294994
• Other study ID #: SecondJilinU-1
• Status: Recruiting
• Phase: Phase 4
• First received: November 16, 2014
• Last updated: November 29, 2014
• Start date: November 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Second Hospital of Jilin University
• Contact: Liu Bin, M.D.
• Phone: +86 13500810268
• Email: liubin3333[@]vip.sina.com
• Is FDA regulated: No
• Health authority: Health and Family Planning commission of Jilin Province: China
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• tirofiban

Locations

Country	Name	City	State
China	The sencond hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net Adverse Clinical Events	A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings	30 days	Yes
Secondary	Net adverse clinical events	a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings	1 year	No
Secondary	any bleedings (BARC class)	including all BARC class (class 1-5)	30 days	Yes
Secondary	Major adverse cardiac and cerebral events (MACCE)	a composite of all cause death, reinfarction, target vessel revascularization or stroke	30 days and 1 year	No
Secondary	stent thrombosis	by ARC definition	30 days and 1 year	Yes