Tirofiban and Enoxaparin in High Risk Coronary Intervention

NCT00790387 | Completed Phase 4

• 1 other identifier: EC2006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  24 hours

Secondary Outcomes (2)

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

  10 minutes , 24 hours

• Inflammatory biomarkers :CD40L,vWF and CRP

  10 minutes,24 hours

Study Arms (2)

1 High dose tirofiban and enoxaparin

EXPERIMENTAL

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.

Drug: Enoxaparin

2 tirofiban and unfractionated heparin

ACTIVE COMPARATOR

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

Drug: Tirofiban; Drug: unfractionated heparin

Interventions

Enoxaparin DRUG

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

1 High dose tirofiban and enoxaparin

Tirofiban DRUG

2 tirofiban and unfractionated heparin

unfractionated heparin DRUG

2 tirofiban and unfractionated heparin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Prince Charles Hospital: lead
• Sanofi: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Enoxaparin; Tirofiban; Heparin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates; Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Darren L Walters

  The Prince Charles Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: November 11, 2008
• First Posted: November 13, 2008
• Study Start: June 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2006
• Last Updated: March 24, 2010

Record last verified: 2008-11

Locations

AU (1)