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Outpatient Percutaneous Coronary Intervention

This study has been terminated.
(Stopped early due to inability to recruit full 100 subjects over 2 years)
Sponsor:
Collaborators:
St. Jude Medical
The Medicines Company
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00419055
First received: January 4, 2007
Last updated: March 29, 2012
Last verified: March 2012

January 4, 2007
March 29, 2012
August 2004
Not Provided
The primary endpoints are patient satisfaction and safety. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The primary endpoints are patient satisfaction and safety.
Complete list of historical versions of study NCT00419055 on ClinicalTrials.gov Archive Site
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Outpatient Percutaneous Coronary Intervention
Outpatient Percutaneous Coronary Intervention in a Selected, Stable Patient Population

To determine the safety and feasibility of same day discharge after elective coronary percutaneous intervention in a selected stable patient population. The hypothesis to be tested is that in an appropriately selected stable coronary artery disease population post percutaneous coronary intervention, early discharge is safe and feasible.

A select stable population of patients undergoing percutaneous coronary intervention are randomized to standard of care in-hospital stay for one night or early discharge to a nearby hotel. During PCI, patients receive bivalirudin as their anti-coagulant and also must be eligible for an angioseal closure device. Patients that stay overnight in the hotel must be accompanied by a family member. They return to the cath lab the next day for groin check and blood work. Satisfaction questionnaires are filled out by all patients.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients less than 75 years who have undergone PCI

Coronary Artery Disease
Procedure: Early discharge after percutaneous coronary intervenntion
Eligible patients receive Bivalirudin at the standard dose during PCI and all have to be eligible for femoral access seal.
  • 1 Control
    Patients are discharged the day after PCI
    Intervention: Procedure: Early discharge after percutaneous coronary intervenntion
  • 2 Study group
    Patients will be discharged 4-6 hrs after PCI
    Intervention: Procedure: Early discharge after percutaneous coronary intervenntion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
August 2006
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Inclusion Criteria:

  • Patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention

Exclusion Criteria:

  • Patients with acute coronary syndrome, patients with an MI within 30 days, an ejection fraction <30%, those with history of IV Dye allergy, creatinine level>2.2, those with increased risk of infection, those with history of bleeding diathesis or anemia (hemoglobin<11.0 g/dl, platelets <100,000 tho/ul)
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00419055
801441
Yes
University of Pennsylvania
University of Pennsylvania
  • St. Jude Medical
  • The Medicines Company
Principal Investigator: Howard C Herrmann, M.D. University of Pennsylvania
Principal Investigator: Ruchira Glaser, M.D. University of Pennsylvania
University of Pennsylvania
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP