- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054365
Same Day Discharge After Coronary Stenting Trial
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90033
- University of Southern California
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Delayed Discharge Group (DDG)
D/C at least 24 hours after procedure or at usual discharge time (n =200)
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Early Discharge Group (EDG)
D/C 6 hours after procedure if no indication for extended stay after randomization (n=200)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rev 09-20-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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