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European Ambulance Acute Coronary Syndrome (ACS) Angiography Trial

2014-08-27 03:15:11 | BioPortfolio

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.

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, re-infarction (MI) or non-CABG-related protocol major bleeding.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

ST Segment Elevation Acute Coronary Syndrome

Intervention

Bivalirudin, Heparin

Location

Wilhelminenspital MA 6 - BA 19
Wien
Austria

Status

Recruiting

Source

The Medicines Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:11-0400

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PubMed Articles [13055 Associated PubMed Articles listed on BioPortfolio]

Outcomes in elderly and young patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention with bivalirudin versus heparin: Pooled analysis from the EUROMAX and HORIZONS-AMI trials.

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Efficacy and safety of bivalirudin for percutaneous coronary intervention in acute coronary syndromes: a meta-analysis of randomized-controlled trials.

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A case report of Brugada-like ST-segment elevation probably due to coronary vasospasm.

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Contrast agent dose and slow/no-reflow in percutaneous coronary interventions : A case-control study of patients with non-ST-segment elevation acute coronary syndromes.

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Medical and Biotech [MESH] Definitions

A clinical syndrome defined by MYOCARDIAL ISCHEMIA symptoms; persistent elevation in the ST segments of the ELECTROCARDIOGRAM; and release of BIOMARKERS of myocardial NECROSIS (e.g., elevated TROPONIN levels). ST segment elevation in the ECG is often used in determining the treatment protocol (see also NON-ST ELEVATION MYOCARDIAL INFARCTION).

A piperazine derivative and PLATELET AGGREGATION INHIBITOR that is used to prevent THROMBOSIS in patients with ACUTE CORONARY SYNDROME; UNSTABLE ANGINA and MYOCARDIAL INFARCTION, as well as in those undergoing PERCUTANEOUS CORONARY INTERVENTIONS.

A clinical syndrome characterized by the development of CHEST PAIN at rest with concomitant transient ST segment elevation in the ELECTROCARDIOGRAM, but with preserved exercise capacity.

A malformation that is characterized by a muscle bridge over a segment of the CORONARY ARTERIES. Systolic contractions of the muscle bridge can lead to narrowing of coronary artery; coronary compression; MYOCARDIAL ISCHEMIA; MYOCARDIAL INFARCTION; and SUDDEN CARDIAC DEATH.

A myocardial infarction that does not produce elevations in the ST segments of the ELECTROCARDIOGRAM. ST segment elevation of the ECG is often used in determining the treatment protocol (see also ST Elevation Myocardial Infarction).

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