Same Day Discharge After Coronary Stenting Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Southern California.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Abbott
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01054365
First received: January 19, 2010
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

In comparison to delayed hospital discharge, a strategy of early hospital discharge of patients who undergo single and multivessel stenting for type A, B, and C lesion(s) using thienopyridine and a hemostatic femoral closure device, is associated with similar clinical outcomes, but greater patient satisfaction and similar cost.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Same Day Discharge After Coronary Stenting Trial

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To compare the strategies, outcomes, and complication rates of early (same day) vs. delayed (day after the procedure) hospital discharge in patients undergoing single and multivessel stenting of type A, B, and C lesions. [ Time Frame: Patients will be followed through hospital course, at 24-72 hours, 7-14 days post discharge and at 30-45 days for clinical evaluation via telephone contact or office visit. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Delayed Discharge Group (DDG)
D/C at least 24 hours after procedure or at usual discharge time (n =200)
Early Discharge Group (EDG)
D/C 6 hours after procedure if no indication for extended stay after randomization (n=200)

Detailed Description:

This study will be a single center prospective, randomized, non-inferiority study of four-hundred patients with stable and unstable angina (CCS class I-IV), type A, B, C lesion(s), single and multivessel disease undergoing single or multivessel coronary artery stenting. All patients will be screened and consented prior to the coronary artery stenting procedure. All patients will receive an oral bolus of a thienopyridine as pre-treatment or immediately after stent implantation. All patients will be anticoagulated with bilvalirudin or heparin during the procedure. Common femoral angiography will be performed at the end of the procedure via the side-arm of the sheath in the ipsilateral oblique view (20-40°). In patients with visible atherosclerotic disease or small common femoral arteries on angiography the size and/or the degree of stenosis will be measured by quantitative angiography. Hemostasis of the femoral-arteriotomy access site will be facilitated by deployment of a hemostatic closure device (StarClose or ProGlide). Patients will be screened and consented prior to cardiac catheterization. If the stenting procedure is performed without complications and the hemostatic closure device successfully deployed the patient will then be evaluated four hours after the completion of the procedure; if there are no complications and the patient is able to ambulate, he/she will be randomized and enrolled into either the early discharge group (EDG) or the delayed discharge group (DDG). Subjects will not be considered enrolled into the study until they have been successfully randomized into either the EDG or DDG group. Patients in the early discharge group (EDG, n=200) will be dismissed from the hospital six hours after hemostatic closure device deployment if the vital signs are stable, no bleeding complications are present, are ambulatory, there are no electrocardiographic changes suggestive of myocardial ischemia and/or arrhythmia and are free of chest pain. Patients in the delayed discharge group (DDG, n=200) will be dismissed from the hospital after the procedure at the discretion of the attending cardiologist but no sooner than 24 hours after PCI. Patients with an indication for extended hospital stay will not be discharged regardless of randomization. A detailed screening log will be kept to track the number of patients screened and consented and will include reason for screening failure (exclusion criteria, procedure related complications, closure device failure, access complication, chest pain, arrhythmias, hemodynamic instability, etc.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This study will include four-hundred consented patients undergoing percutaneous coronary stenting at the University of Southern California Hospital or LA County Hospital, patients in the study group will be discharged the day of the procedure whereas patients in the control group will be discharged at the discretion of the attending cardiologist not earlier than 24 hours after their procedure. Patients will be stratified on the basis of their initial clinical presentation, as determined by the medical history, physical examination, ECG and laboratory studies. Patients must be hemodynamically stable, and able to understand and sign an informed consent.

Criteria

Inclusion Criteria:

  • Patients undergoing single and multivessel stenting of type A, B, and C de novo lesion(s) for the treatment of stable and unstable angina (CCS class I-IV).
  • Patients will be treated with thienopyridine oral bolus, either as a pre-treatment or immediately after stenting, and recommended to be continued on daily.
  • Patients will be anticoagulated with intravenous heparin or bilvalirudin during the procedure and stopped immediately after completion of the procedure.

Arterial access via the femoral artery (Sheath 5, 6, 7 or 8 French) and an arteriotomy site suitable for hemostatic device closure. Suitability for closure, defined as at least 5 mm from a bifurcation, puncture must not include the artery femoralis profunda or the superficial femoral artery, TIMI III coronary flow upon completion of the intervention and Left ventricular ejection fraction (LVEF) less than 40 per cent.

  • Patients who live less than an hour away from the hospital.

Exclusion Criteria:

  • Age less than 30 years old or greater than 80 years old
  • Acute STEMI
  • Non-STEMI with documented troponin greater than 10 at presentation to the catheterization laboratory
  • Cardiogenic shock or hemodynamic instability
  • Severe valvular heart disease
  • Any contraindication to anticoagulation
  • Pregnancy
  • Patients with bleeding diathesis (including thrombocytopenia (platelets less than 100,000), thrombasthenia, Von WilleBrand's disease, or anemia (Hgb less than 10 mg per dl, Hct less than 30) or coagulopathy
  • Patients with a Creatinine greater than 1.5 mg/ml
  • Patients with an INR greater than 1.5
  • Patients with cancer or autoimmune disease
  • Patients who live greater than 60 minutes away from the hospital
  • Patients who will not be able to follow-up
  • Patients with inadequate social or home support (homeless, lives alone, etc)
  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: NCT01054365

Contacts
Contact: Leonardo Clavijo, MD, PhD 323-442-6130 lclavijo@usc.edu
Contact: Ray Matthews, MD 323-442-6130 raymatth@usc.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Leonardo Clavijo, MD, PhD    323-442-6130    lclavijo@usc.edu   
Contact: Ray Matthews, MD    323-442-6130    raymatth@usc.edu   
Sponsors and Collaborators
University of Southern California
Abbott
Investigators
Principal Investigator: Leonardo Clavijo, MD, PhD University of Southern California
  More Information

No publications provided

Responsible Party: Leonardo Clavijo, MD, PhD, University of Southern California
ClinicalTrials.gov Identifier: NCT01054365     History of Changes
Other Study ID Numbers: Rev 09-20-09
Study First Received: January 19, 2010
Last Updated: January 21, 2010
Health Authority: United States: Institutional Review Board

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 July 23, 2014