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PITT PCI Xience Registry

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ClinicalTrials.gov Identifier: NCT01299207
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Oscar Marroquin, University of Pittsburgh

Brief Summary:

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
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
Study Start Date : August 2011
Primary Completion Date : February 2015
Study Completion Date : December 2015

Group/Cohort
CAD treated with Xience stents
Patients with CAD who undergo successful stenting with the Xience drug-eluting stent will represent the patient population.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Major Bleeding Events [ Time Frame: 24 months ]
    A combined endpoint including subarachnoid hemorrhage, intracerebral hemorrhage, other/unspecified intracranial hemorrhage, gastric ulcer or gastrointestinal hemorrhage.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  • Undergoing a coronary stenting procedure with the Xience drug-eluting stent
  • Signed informed consent

Exclusion Criteria:

  • Inability to sign informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299207


Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Abbott
Investigators
Principal Investigator: Oscar C Marroquin, MD University of Pittsburgh

Responsible Party: Oscar Marroquin, Study Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01299207     History of Changes
Other Study ID Numbers: 0022189
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Keywords provided by Oscar Marroquin, 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