Fondaparinux Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS)

Completed · Phase 4

Conditions studied: Acute Coronary Syndrome

In brief

The purpose of this study is to compare the safety of two different dose regimens of unfractionated heparin (UFH) during a percutaneous coronary intervention (PCI) procedure in patients with UA (unstable angina)/NSTEMI (non ST segment elevation myocardial infarction) who have been initially treated with fondaparinux.

Key facts

Study ID

NCT00790907

Run by

GlaxoSmithKline

People needed

3235

Starts

2009-02-01

Expected to finish

2010-05-01

Last updated by the study team

2017-03-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presenting or admitted to hospital with symptoms suspected to represent UA or NSTEMI, i.e., clinical history consistent with new onset, or a worsening pattern of, characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than 5 minutes or requiring sublingual nitro-glycerine for relief of the pain).
• Available to be enrolled within 48 hours of the onset of the most recent episode of symptoms.
• Planned coronary angiography, with PCI if indicated, within 72 hours of enrollment where possible.
• At least two of the three following additional criteria:
• Age greater than or equal to 60 years
• Troponin T or I or CK-MB above the upper limit of normal for the local institution;
• Electrocardiogram (ECG) changes compatible with ischemia, i.e., ST depression at least 1 mm in 2 contiguous leads or T wave inversion > 3 mm or any dynamic ST shift or transient ST elevation.
• Written informed consent dated and signed

You may not qualify if…

• Age < 21 years.
• Any contraindication to UFH or fondaparinux
• Contraindication for angiography or PCI at baseline
• Subjects requiring urgent (<120 minutes) coronary angiography as characterized by those with:
• refractory or recurrent angina associated with dynamic ST-deviation
• heart failure
• life-threatening arrhythmias
• hemodynamic instability
• Subjects already receiving treatment with enoxaparin (or other LMWH), bivalirudin or UFH for treatment of the qualifying events unless the last administered (intravenous(i.v.) or s.c.) dose was:
• ≥ 8 hours for low molecular weight heparin (LMWH)
• ≥60 minutes for bivalirudin
• ≥90 minutes for unfractionated heparin (UFH)
• Hemorrhagic stroke within the last 12 months.
• Indication for anti-coagulation other than acute coronary syndrome (ACS) during the index hospitalization.
• Pregnancy or women of childbearing potential who are not using an effective method of contraception.
• Co-morbid condition with life expectancy less than 6 months.
• Currently receiving an experimental pharmacological agent.
• Revascularization procedure already performed for the qualifying event.
• Severe renal insufficiency (i.e., estimated creatinine clearance <20 ml/min)
• Following angiography and confirmation that the subject is to undergo PCI, the subject must also meet all of the following additional criteria in order to be randomised:
• Subjects will have received at least 1 dose of open-label fondaparinux
• The most recent dose of open-label fondaparinux will not have been more than 24 hours before the start of the PCI procedure.

Where it is running

• GSK Investigational Site — Albuquerque, New Mexico, United States
• GSK Investigational Site — Syracuse, New York, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Adrogué, Buenos Aires, Argentina
• GSK Investigational Site — Bahía Blanca, Buenos Aires, Argentina
• GSK Investigational Site — La Plata, Buenos Aires, Argentina
• GSK Investigational Site — Merlo, Buenos Aires, Argentina
• GSK Investigational Site — Quilmes, Buenos Aires, Argentina
• GSK Investigational Site — Quilmes, Buenos Aires, Argentina
• GSK Investigational Site — Rosario, Buenos Aires, Argentina
• GSK Investigational Site — Corrientes, Corrientes Province, Argentina
• GSK Investigational Site — Rosario, Santa Fe Province, Argentina
• GSK Investigational Site — Santa Fe, Santa Fe Province, Argentina
• GSK Investigational Site — Santa Fe, Santa Fe Province, Argentina
• GSK Investigational Site — Buenos Aires, Argentina
• GSK Investigational Site — San Miguel de Tucumán, Argentina
• GSK Investigational Site — Campina Grande do Sul, Paraná, Brazil
• GSK Investigational Site — Curitiba, Paraná, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• GSK Investigational Site — Blumenau, Santa Catarina, Brazil
• GSK Investigational Site — Campinas, São Paulo, Brazil
• GSK Investigational Site — Marília, São Paulo, Brazil
• GSK Investigational Site — Ocala, Florida, United States

Full record on ClinicalTrials.gov

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