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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Calcium heparin; Fondaparinux; Heparin; PENTA

Criteria

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.