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

Sponsor
Second Hospital of Jilin University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02294994
Collaborator
(none)
1,000
Enrollment
1
Location
3
Arms
25
Duration (Months)
40
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: half dose tirofiban

Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.075 µg per kilogram per minute for 24 to 36 hours.UFH heparin was administered as a bolus of 100 U/kg before PCI.

Drug: tirofiban
Other Names:
  • GPIIb/IIIa inhibitor
  • aggrastat

    		•
    Active Comparator: recommended-dose Tirofiban

    Tirofiban was administered once the wire had crossed the lesion during PCI with a bolus dose of 25 µg/kg of bodyweight, followed by an infusion of 0.15 µg per kilogram per minute for 18 to 24 hours. UFH heparin was administered as a bolus of 100 U/kg before PCI.

    Drug: tirofiban
    Other Names:
  • GPIIb/IIIa inhibitor
  • aggrastat

    		•
    Placebo Comparator: none tirofiban

    Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.

    Drug: tirofiban
    Other Names:
  • GPIIb/IIIa inhibitor
  • aggrastat

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Net Adverse Clinical Events [30 days]

      A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings

    Secondary Outcome Measures

    1. Net adverse clinical events [1 year]

      a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings

    2. any bleedings (BARC class) [30 days]

      including all BARC class (class 1-5)

    3. Major adverse cardiac and cerebral events (MACCE) [30 days and 1 year]

      a composite of all cause death, reinfarction, target vessel revascularization or stroke

    4. stent thrombosis [30 days and 1 year]

      by ARC definition

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The sencond hospital of Jilin University Changchun Jilin China 130041

    Sponsors and Collaborators

    • Second Hospital of Jilin University

    Investigators

    • Principal Investigator: Liu Bin, M.D., Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT02294994
    Other Study ID Numbers:
    • SecondJilinU-1
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Tirofiban

    Study Results

    No Results Posted as of Dec 2, 2014