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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
tirofiban
Sponsored by
Second Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The sencond hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

half dose tirofiban

recommended-dose Tirofiban

none tirofiban

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Net adverse clinical events
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
any bleedings (BARC class)
including all BARC class (class 1-5)
Major adverse cardiac and cerebral events (MACCE)
a composite of all cause death, reinfarction, target vessel revascularization or stroke
stent thrombosis
by ARC definition

Full Information

First Posted
November 16, 2014
Last Updated
November 29, 2014
Sponsor
Second Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT02294994
Brief Title
Efficacy and Safety of Different Dose of Tirofiban in Interventional Treatment of Complex Coronary Artery Disease
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Hospital of Jilin University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
half dose tirofiban
Arm Type
Experimental
Arm Description
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.
Arm Title
recommended-dose Tirofiban
Arm Type
Active Comparator
Arm Description
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.
Arm Title
none tirofiban
Arm Type
Placebo Comparator
Arm Description
Tirofiban was not administered ,UFH heparin was administered as a bolus of 100 U/kg before PCI.
Intervention Type
Drug
Intervention Name(s)
tirofiban
Other Intervention Name(s)
GPIIb/IIIa inhibitor, aggrastat
Primary Outcome Measure Information:
Title
Net Adverse Clinical Events
Description
A composite of all cause death, reinfarction, urgent target vessel revascularization, stroke and any bleedings
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Net adverse clinical events
Description
a composite of all cause death, any myocardial infarction, any target vessel revascularization, stroke or any bleedings
Time Frame
1 year
Title
any bleedings (BARC class)
Description
including all BARC class (class 1-5)
Time Frame
30 days
Title
Major adverse cardiac and cerebral events (MACCE)
Description
a composite of all cause death, reinfarction, target vessel revascularization or stroke
Time Frame
30 days and 1 year
Title
stent thrombosis
Description
by ARC definition
Time Frame
30 days and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Bin, M.D.
Phone
+86 13500810268
Email
liubin3333@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Bin, M.D.
Organizational Affiliation
Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The sencond hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Bin, M.D.
Phone
+86 13500810268
Email
liubin3333@vip.sina.com

12. IPD Sharing Statement

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

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