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

Subjects presenting at hospital with suspected UA or NSTEMI and who are likely to undergo
angiography (ideally within 72 hours) will be assessed for eligibility and consented.
Suitable subjects will be enrolled and commence treatment with open-label fondaparinux, 2.5
milligram (mg), subcutaneous (s.c.), once daily. Following angiography subjects indicated
for PCI and meeting the additional requirements for randomization will be randomised to
receive one of two dose regimens of UFH either standard dose or low dose immediately prior
to the PCI procedure. Post-PCI, therapy with fondaparinux (2.5 mg, s.c.) may be resumed at
the investigator's discretion for up to a maximum of 8 days or hospital discharge, whichever
is earlier.

Subjects not indicated for PCI, will continue treatment with fondaparinux, 2.5mg, s.c, once
daily for up to 8 days or hospital discharge, whichever is earlier.

All subjects will be followed up for 30 days after randomization/angiography.

The following are inclusion and exclusion criteria for enrollment in the study:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.