PITT PCI Xience Registry
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Purpose
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 |
|---|
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Coronary Artery Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | PITT PCI Xience Registry: A Prospective Evaluation of Dual Antiplatelet Therapy Compliance and Outcomes After Treatment With the Xience Stent |
- Major Adverse Cardiovascular Events (MACE) [ Time Frame: 24 months ] [ Designated as safety issue: No ]Combined end-point of all cause mortality, non-fatal myocardial infarction, stent thrombosis, need for repeat revascularization.
- Major Bleeding Events [ Time Frame: 24 months ] [ Designated as safety issue: No ]A combined endpoint including subarachnoid hemorrhage, intracerebral hemorrhage, other/unspecified intracranial hemorrhage, gastric ulcer or gastrointestinal hemorrhage.
| Estimated Enrollment: | 3500 |
| Study Start Date: | August 2011 |
| Groups/Cohorts |
|---|
|
CAD treated with Xience stents
Patients with CAD who undergo successful stenting with the Xience drug-eluting stent will represent the patient population.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population will consist of all consecutive patients who undergo coronary stenting with the Xience drug-eluting stent in any of the 4 University of Pittsburgh Medical Center's Hospitals (UPMC Presbyterian, UPMC Shadyside, UPMC Mercy, and UPMC Passavant).
Inclusion Criteria:
- Undergoing a coronary stenting procedure with the Xience drug-eluting stent
- Signed informed consent
Exclusion Criteria:
- Inability to sign informed consent.
Contacts and Locations| Contact: Frani M Averbach, MPH, RD | (412) 624-3773 | averbachf@edc.pitt.edu |
| Contact: Elizabeth Passano, MS | (412) 624-5473 | passano@edc.pitt.edu |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: Oscar C Marroquin, MD | |
| Principal Investigator: | Oscar C Marroquin, MD | University of Pittsburgh |
More Information
No publications provided
| Responsible Party: | Oscar Marroquin, Study Principal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT01299207 History of Changes |
| Other Study ID Numbers: | 0022189 |
| Study First Received: | February 15, 2011 |
| Last Updated: | January 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Stents Drug-Eluting Stents Stent Thrombosis Bleeding Dual-Antiplatelet Therapy |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013