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Tirofiban and Enoxaparin in High Risk Coronary Intervention

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Enoxaparin

Tirofiban

unfractionated heparin

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring enoxaparin, tirofiban, percutaneous intervention, platelet inhibition, CD40L, Mac-1, prothrombin fragment 1+2.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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 that included intraluminal filling defect, angiographically visible thrombus eccentric lesion, type, location in a proximal major vessel and thrombolysis in myocardial infarction (TIMI) flow of II or less

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 Prince Charles Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 High dose tirofiban and enoxaparin

2 tirofiban and unfractionated heparin

Arm Description

Enoxaparin was administered at the commencement of PCI at a dose of 0.75 mg/kg . 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.

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 70 U/kg and additional heparin was given to maintain the activated clotting time (ACT) at 250

Outcomes

Primary Outcome Measures

Thrombus generation as determined by Prothrombin fragment 1+2, D-dimer

Secondary Outcome Measures

A panel of platelet activation markers:P selectin, MAC-1, PMAs, factor V/Va,Platelet inhibition as assessed by whole blood aggregometry

Inflammatory biomarkers :CD40L,vWF and CRP

Full Information

NCT ID

NCT00790387

First Posted

November 11, 2008

Last Updated

March 23, 2010

Sponsor

The Prince Charles Hospital

Collaborators

Sanofi, Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00790387

Brief Title

Tirofiban and Enoxaparin in High Risk Coronary Intervention

Official Title

High Bolus Dose Tirofiban and Enoxaparin Provides Reduced Thrombin Generation and Inflammatory Markers in Patients With High Risk Undergoing Percutaneous Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

June 2004 (undefined)

Primary Completion Date

December 2005 (Actual)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

The Prince Charles Hospital

Collaborators

Sanofi, Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Patients undergoing coronary angioplasty are frequently treated with new drugs that stop blood platelets working and so improve the success of the procedure. Individual patients may vary in the dose of the drug required. New platelet tests have been developed which can be performed near the patient and possibly immediately tell the doctor the degree of platelet inhibition achieved so that the dose can be adjusted accordingly. This study aims to investigate if these platelet tests indicate if new anticoagulants are more effective at inhibiting platelet function than the traditional anticoagulants. The study will demonstrate if these newer drugs improve blood flow through the heart muscle and thereby provide better long term outcomes for patients undergoing percutaneous intervention.

Detailed Description

Objectives: The study assessed the benefit of high bolus dose tirofiban with enoxaparin compared to unfractionated heparin. Introduction: The benefit of the use of glycoprotein IIb/IIa inhibitors with low molecular weight heparins in high risk patients undergoing percutaneous intervention (PCI) over traditional unfractionated heparin (UFH) is debated. Methods; The study is a prospective single center open-label trial of patients with high-risk acute coronary syndrome treated with PCI who were randomised to anticoagulation with UFH or enoxaparin with 'high dose' (25 mcg/kg bolus) tirofiban This study measured a panel of platelet activation markers, inflammatory biomarkers and thrombus generation between the two groups.

6. Conditions and Keywords

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

Acute Coronary Syndrome

Keywords

enoxaparin, tirofiban, percutaneous intervention, platelet inhibition, CD40L, Mac-1, prothrombin fragment 1+2.

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 High dose tirofiban and enoxaparin

Arm Type

Experimental

Arm Description

Arm Title

2 tirofiban and unfractionated heparin

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enoxaparin

Intervention Description

Enoxaparin was administered at the commencement of PCI at a dose of 0.75 mg/kg

Intervention Type

Drug

Intervention Name(s)

Tirofiban

Intervention Type

Drug

Intervention Name(s)

unfractionated heparin

Primary Outcome Measure Information:

Title

Thrombus generation as determined by Prothrombin fragment 1+2, D-dimer

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

A panel of platelet activation markers:P selectin, MAC-1, PMAs, factor V/Va,Platelet inhibition as assessed by whole blood aggregometry

Time Frame

10 minutes , 24 hours

Title

Inflammatory biomarkers :CD40L,vWF and CRP

Time Frame

10 minutes,24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 that included intraluminal filling defect, angiographically visible thrombus eccentric lesion, type, location in a proximal major vessel and thrombolysis in myocardial infarction (TIMI) flow of II or less 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darren L Walters

Organizational Affiliation

The Prince Charles Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Prince Charles Hospital

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

12. IPD Sharing Statement

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Tirofiban and Enoxaparin in High Risk Coronary Intervention

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