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PITT PCI Xience Registry

This study has been completed.
Information provided by (Responsible Party):
Oscar Marroquin, University of Pittsburgh Identifier:
First received: February 15, 2011
Last updated: January 5, 2016
Last verified: January 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.

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

Further study details as provided by Oscar Marroquin, University of Pittsburgh:

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

Enrollment: 2506
Study Start Date: August 2011
Study Completion Date: December 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
CAD treated with Xience stents
Patients with CAD who undergo successful stenting with the Xience drug-eluting stent will represent the patient population.

  Show Detailed Description


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).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01299207

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

Responsible Party: Oscar Marroquin, Study Principal Investigator, University of Pittsburgh Identifier: NCT01299207     History of Changes
Other Study ID Numbers: 0022189
Study First Received: February 15, 2011
Last Updated: January 5, 2016

Keywords provided by Oscar Marroquin, University of Pittsburgh:
Drug-Eluting Stents
Stent Thrombosis
Dual-Antiplatelet Therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on August 23, 2017