PITT PCI Xience Registry
|ClinicalTrials.gov Identifier: NCT01299207|
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : January 7, 2016
Stents are devices utilized to treat cholesterol blockages of the coronary (heart) arteries. The introduction of drug-eluting (coated) stents into clinical practice is regarded as a revolutionary breaktrhough, as it has reduced the incidence of re-narrowing of the arteries after percutaneous coronary interventions are performed. There has been, however, concerns of increased risk for clot formation in the heart arteries of patients treated with drug-eluting stents. Therefore, in order to lower the risk of clot formation, it is recommended that patients receiving these types of stents, be treated with dual antiplatelet therapy (blood thinning medication) for one year. The effect of this strategy, however, on clot formation and bleeding complications when utilizing "newer generation" stents, such as the Xience: Everolimus-eluting Stent, have not been well described.
Therefore, the aim of this registry study is to evaluate the risk of adverse cardiovascular events, including mortality, non-fatal myocardial infarction, stent thrombosis, hemorrhagic stroke, and severe bleeding in relation to the timing and discontinuation of dual antiplatelet therapy in patients treated with Xience drug-eluting stents, and compare it to patients that do not discontinue dual antiplatelet therapy.
|Condition or disease|
|Coronary Artery Disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||2506 participants|
|Official Title:||PITT PCI Xience Registry: A Prospective Evaluation of Dual Antiplatelet Therapy Compliance and Outcomes After Treatment With the Xience Stent|
|Study Start Date :||August 2011|
|Primary Completion Date :||February 2015|
|Study Completion Date :||December 2015|
CAD treated with Xience stents
Patients with CAD who undergo successful stenting with the Xience drug-eluting stent will represent the patient population.
- Major Adverse Cardiovascular Events (MACE) [ Time Frame: 24 months ]Combined end-point of all cause mortality, non-fatal myocardial infarction, stent thrombosis, need for repeat revascularization.
- Major Bleeding Events [ Time Frame: 24 months ]A combined endpoint including subarachnoid hemorrhage, intracerebral hemorrhage, other/unspecified intracranial hemorrhage, gastric ulcer or gastrointestinal hemorrhage.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299207
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Oscar C Marroquin, MD||University of Pittsburgh|