Same Day Discharge After Coronary Stenting Trial
Completed
Conditions studied: Coronary Artery Disease
In brief
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.
Key facts
- Study ID
- NCT01054365
- Run by
- Leonardo Clavijo
- People needed
- 100
- Starts
- 2009-12-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-04-04
Who can join
Age: 30 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- University of Southern California — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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