PITT PCI Xience Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Oscar Marroquin, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01299207
First received: February 15, 2011
Last updated: January 11, 2012
Last verified: January 2012
  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
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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  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
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.
  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 ClinicalTrials.gov identifier: NCT01299207

Contacts
Contact: Frani M Averbach, MPH, RD (412) 624-3773 averbachf@edc.pitt.edu
Contact: Elizabeth Passano, MS (412) 624-5473 passano@edc.pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Oscar C Marroquin, MD         
Sponsors and Collaborators
University of Pittsburgh
Abbott
Investigators
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 September 22, 2014