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Relationship of Activated Clotting Time and Bleeding Related Outcomes in the FUTURA OASIS-8 Trial
Proposal
637
Title of Proposed Research
Relationship of Activated Clotting Time and Bleeding Related Outcomes in the FUTURA OASIS-8 Trial
Lead Researcher
Sripal Bangalore
Affiliation
Sripal Bangalore, MD, MHA, FACC, FSCAI
Funding Source
None
Potential Conflicts of Interest
Data Sharing Agreement Date
24 September 2013
Lay Summary
Activated clotting time (ACT) is used as a measure of degree of anticoagulation (how thin the blood is) in response to the use of unfractionated heparin (UFH) (blood thinner) during percutaneous coronary intervention (PCI) (stenting procedure of the heart arteries). The target goal for ACT is a balance between the risk of ischemic complications (complications due to clotting) (due to inadequate blood thinning reflected by a low ACT) vs. bleeding complications (due to excessive blood thinning reflected by a high ACT). However, the relationship of ACT with bleeding and ischemic events in patients receiving both UFH and low molecular weight heparin (LMWH) is not well defined. In addition, an optimal ACT target for such patients receiving both UFH and LMWH is not well defined. Moreover, most of the prior studies that evaluated ACT and bleeding predated modern use of potent antiplatelet agents (such as clopidogrel and GP IIb/IIIa inhibitors).
Study Data Provided
[{ "PostingID": 48, "Title": "GSK-AR1108888", "Description": "FondaparinUx Trial with Unfractionated Heparin (UFH) during Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A prospective study evaluating the safety of two regimens of adjunctive intravenous UFH during PCI in high risk patients with Unstable Angina/Non ST segment elevation myocardial infarction (UA/NSTEMI) initially treated with subcutaneous fondaparinux and referred for early coronary angiography (OASIS 8)
Medicine: fondaparinux sodium, Condition: Acute Coronary Syndrome, Phase: 4, Clinic" }]
Statistical Analysis Plan
This will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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