Coronary Artery DiseaseNCT01054365
Same Day Discharge After Coronary Stenting Trial
An observational study of Coronary Artery Disease, run by Leonardo Clavijo at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonardo Clavijo
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Leonardo Clavijo, University of Southern California
- Investigators
- Leonardo Clavijo, MD, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054365
- Sponsor's protocol ID
- Rev 09-20-09
- Status last verified
- Jan 2010
- First submitted
- 19 Jan 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Discharge After Coronary Stenting Trial
- ClinicalTrials.gov ID
- NCT01054365
- Acronym / sponsor ID
- Rev 09-20-09
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Leonardo ClavijoUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Dec 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonardo Clavijo, MD, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Leonardo Clavijo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.