A Study of Fondaparinux and Heparin in Acute Coronary Syndrome

• Research type

  Research Study

• Full title

  FondaparinUx Trial with UFH during Revascularization in Acute Coronary Syndromes (FUTURA) A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with UA/NSTEMI initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)

• IRAS ID

  5929

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2008-002747-16

• Clinicaltrials.gov Identifier

  00790907

• Research summary

  Unstable angina (UA) is chest pain occurring suddenly, often at rest or with minimal exertion. Non-ST-segment elevation myocardial infarction (NSTEMI) is a minor heart attack defined by changes on an ECG associated with some heart muscle injury. Both clinical conditions are referred to as acute coronary syndromes (ACS) and are a major cause of medical emergencies worldwide. Patients presenting with these conditions are at high risk of recuurent angina, major heart attack and death. Blood thinning drugs such as heparin and fondaparinux, used in this study, and early intervention such as coronary angiography (an invasive procedure to visualise the inside of blood vessels) may improve the outcomes for these patients but are both associated with an increase in bleeding complications. In the main study, patients admitted to hospital with ACS will receive treatment with fondaparinux. If a PCI (percutaneous coronary intervention) ie angioplasty (procedure to restore the blood flow in the vessels of the heart) is not required then the patient will continue with fondaparinux for 8 days or until discharged from hospital. If the patient does require an angioplasty, then they will receive a blinded dose (the study doctor nor patient will not know which dose) of heparin. All patients will be followed up for 30 days. The main aim of the study is to test how safe and effective either a standard or low dose of heparin is in patients already receiving fondaparinux and who require an angioplasty.There are also 2 smaller sub studies for patients requiring angioplasty.These sub-studies (blood and multi vessel disease) will provide doctors with more information on i) how fondaparinux affects blood clotting factors and how these relate to the outcomes of the condition being studied and ii) whether it is better to restore blood flow to one artery compared to unblocking all the affected arteries.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/136

• Date of REC Opinion

  2 Dec 2008

• REC opinion

  Further Information Favourable Opinion