Overview

This trial is active, not recruiting.

Condition st segment elevation acute coronary syndrome
Treatments bivalirudin, heparin
Phase phase 3
Sponsor The Medicines Company
Start date February 2010
End date August 2013
Trial size 2218 participants
Trial identifier NCT01087723, TMC-BIV-08-03

Summary

To show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with ST segment elevation Acute Coronary Syndrome (STE-ACS), intended for a primary Percutaneous Coronary Intervention (PCI) management strategy, presenting either via ambulance or to centres where PCI is not performed.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
bivalirudin
0.75 mg/kg bolus followed by 1.75 mg/kg/hr infusion
(Active Comparator)
•Heparin: IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).
heparin
IV bolus at a usual starting dose of 100 U/Kg weight (60 U/kg if GPI is used).

Primary Outcomes

Measure
A composite of death and non-CABG-related protocol major bleeding
time frame: 30 days

Secondary Outcomes

Measure
Death at 1 year
time frame: 30 days and 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: The decision to randomise patients must be made by a qualified physician or paramedic who is present at the time. Subjects may be included in the study if they present either via ambulance or to a centre where PCI is not performed and meet all of the following criteria: 1. Provide written informed consent before initiation of any study related procedures. Patients randomised in the ambulance may initially sign an abridged version. 2. Be aged ≥18 years at the time of randomisation. 3. Have a presumed diagnosis of a STE-ACS with onset of symptoms of >20 minutes and <12 hours with one or more of the following: - ST segment elevation of ≥1 mm in ≥2 contiguous leads - Presumably new left bundle branch block - An infero-lateral MI with ST segment depression of ≥1 mm in ≥2 of leads V1-3) with a positive terminal T wave 4. All patients must be scheduled for angiography +/- PCI (if indicated) <2 hours after first medical contact Exclusion Criteria: Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomisation: 1. Any bleeding diathesis or severe haematological disease or history of intra-cerebral mass, aneurysm, arterio-venous malformation, haemorrhagic stroke, intra-cranial haemorrhage or gastrointestinal or genitourinary bleeding within the last 2-weeks. 2. Patients who have undergone recent surgery (including biopsy) within the last two weeks. 3. Patients on warfarin (not applicable if INR known to be <1.5). 4. Patients who have received UFH, LMWH or bivalirudin immediately before randomisation. 5. Thrombolytic therapy within the last 48 hours. 6. Absolute contraindications or allergy that cannot be pre-medicated to iodinated contrast or to any of the study medications including aspirin or clopidogrel. 7. Contraindications to angiography, including but not limited to severe peripheral vascular disease. 8. If it is known pregnant or nursing mothers. Women of child-bearing age will be asked if they are pregnant or think that they may be pregnant. 9. If it is known a creatinine clearance <30 mL/min or dialysis dependent. 10. Previous enrolment in this study. 11. Treatment with other investigational drugs or devices within the 30 days preceding randomisation or planned use of other investigational drugs or devices in this trial. 12. Patients may not be enrolled if the duration of randomised investigational medicinal product (IMP) anti-thrombin infusion is likely to be less than 30 minutes from the time of onset to the commencement of angiography. 13. Patients may not be enrolled within a primary PCI capable hospital (unless at the time of randomisation the catheter laboratory is not available and the patient requires transfer to another primary PCI capable hospital). 14. Estimated body weight of >120 kg

Additional Information

Description The purpose of the trial is to show that the early administration of bivalirudin improves 30 day outcomes when compared to the current standard of care in patients with STE-ACS, with an onset of symptoms of >20 minutes and <12 hours, intended for a primary PCI management strategy, presenting either via ambulance or to centres where PCI is not performed. All patients are to receive treatment with aspirin (150-325 mg oral or 250-500 mg IV) followed by 75-100 mg/day for at least 1 year and a P2Y12 receptor blocker (such as clopidogrel 300 mg or 600 mg followed by 75 mg daily) as soon as logistically feasible. The primary objectives of the trial are to show that, when compared with standard anti-thrombotic therapies other than bivalirudin (which includes treatment with unfractionated heparin and optional GPI) that at 30 days: • Bivalirudin is superior to control at reducing a composite of death and non-CABG-related protocol major bleeding.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by The Medicines Company.