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Coronary Artery DiseasePhase 4NCT00169819

EArly Discharge After Transradial Stenting of CoronarY Arteries: The EASY Study

A Phase 4 study testing Abciximab in people with Coronary Artery Disease and Ischemia, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

HYPOTHESES Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective. Hospitalized patients can be safely returned to the referring center the same day following trans-radial coronary artery stenting. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, Ischemia
What is being tested?
Abciximab
How many people
1,000 participants
Where
1 siteCanada
Study dates
Oct 2003to Apr 2006
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with documented ischemic coronary artery disease and scheduled for possible coronary artery stenting are eligible.
  • Patient must be > 18 years of age.
  • Patient and treating interventional cardiologist agree for randomization.
  • Patient will be informed of the randomization process and will sign an informed consent.
  • Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.

Who cannot join

  • CLINICAL:
  • Patients with recent (< 72 hrs) Q-wave (ST elevation) acute myocardial infarction.
  • History of LV ejection fraction ≤ 30%.
  • Unstable clinical condition.
  • Any complication compromising ambulation
  • Concurrent participation in other investigational study requiring prolonged hospitalization
Show all 26Show fewer
  • Required prolonged hospitalization
  • In-cath lab transient vessel closure
  • Resuscitation per PCI
  • Hemodynamic collapse during PCI
  • Severe entry site complication upon investigator decision
  • Social isolation
  • Serious cognitive disorders
  • Femoral sheath (artery)
  • Persisting chest pain
  • No ASA prior PCI
  • Allergy to ASA or thienopyridines precluding treatment for 30 days
  • Any significant blood dyscrasia
  • PCI without stent implantation (except for bifurcation lesion or re-dilatation for in-stent restenosis)
  • International Normalised Ratio (INR) > 2.0
  • Contraindication to Reopro administration
  • ANGIOGRAPHIC
  • Residual dissection of grade ≥ B of NHBLI classification.
  • Compromised or sub-occluded branch with diameter ≥ 1 mm.
  • Timi < 3 post-stenting
  • Thrombus post-PCI

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Laval Hospital Research Center

    Sainte-Foy, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: A Randomized Trial Comparing Same Day Discharge and a Single Bolus of Abciximab to Overnight Hospitalization and Bolus + Perfusion Abciximab After Uncomplicated Trans-Radial Coronary Artery Stenting

HYPOTHESES

  • Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective.
  • Hospitalized patients can be safely returned to the referring center the same day following trans-radial coronary artery stenting.
  • Abciximab given as a single bolus with optimal trans-radial coronary artery stenting is as safe and effective as bolus + 12 hrs perfusion and does not hamper early discharge.
  • Same-day discharge is cost-effective and increases patient satisfaction.
Read more

OBJECTIVES AND END-POINTS

The objectives of the present study are to assess the effectiveness and safety of same day hospital discharge after uncomplicated coronary artery stenting when a single bolus of Abciximab is used. The primary end-point of the study is the composite of death, myocardial infarction, repeat hospitalization, urgent revascularization, severe thrombocytopenia, access site complications and major bleedings at 30 days following stent implantation.

The secondary end-point is the composite of death, myocardial infarction, repeat target vessel revascularization at 30 days, 6 months and 1 year following stent implantation. Other secondary end-points include the total hospital stay (days) between the index procedure and the first 30 days follow-up, the number of unsolicited medical visits in relation with the percutaneous procedure, index of patient satisfaction and direct and indirect costs.

Read the detailed description

Despite significant improvements in clinical results associated with the current use of stenting and pharmacologic agents there has been little modification in hospitalization duration after percutaneous coronary interventions (PCI). The main reasons associated with prolonged hospitalization after PCI remain 1) the fear of abrupt vessel closure and its associated morbidity 2) the need for prolonged bed rest in case of femoral approach even after use of device closures.

The introduction of coronary stents has been associated with a dramatic decrease in vessel closure once it was recognized that stent deployment required higher pressure balloon inflation and increased antiplatelet therapy. Trans-radial coronary interventions appear safer and more cost-effective than femoral PCI. However, the current use of IIb-IIIa inhibitors prohibits the early discharge of patients following PCI because their pharmacology generally imposes to pursue drug infusion between 18 and 24 hrs following PCI which does not allow same day discharge from the hospital. With Abciximab, however, pharmacologic data indicate that prolonged platelet inhibition (≥ 80%) occurs after a single bolus. Based on the EPIC trial results, it has been recommended to prolong platelet inhibition by a 12 hrs perfusion. By analyzing carefully the EPIC trial results, we hypothesized that after optimal stenting result, a single bolus of Abciximab would suffice. We aim to demonstrate that (1) with trans-radial coronary stenting at least 50% of the entire population referred for PCI could be safely discharged after a few hours observation; (2) a single bolus of Abciximab is at least as effective as current recommended treatment with a bolus + 12 hrs perfusion after uncomplicated stenting. This new regimen could significantly affect current practice, decrease hospital costs and increase patient satisfaction after PCI.

STUDY DESIGN

A prospective randomized single-center study comparing same day hospital discharge to overnight hospitalization after uncomplicated trans-radial coronary artery stenting. Out-patients will be randomized after successful stent implantation to same day discharge or will remain hospitalized at Laval Hospital until the next morning. Hospitalized patients will be randomized after successful stent implantation to either same day discharge at home or to overnight hospitalization (either at the referring center or at Laval Hospital). All eligible patients will be treated with Abciximab that will be administered according to 2 different arms: For patients randomized to same-day discharge, only a bolus of Abciximab will be given, whereas for all remaining patients, Abciximab will be given according to current practice i.e. bolus + 12 hrs perfusion. All patients which will not be eligible post-PCI will enter a registry.

Being tested
Abciximab
Keywords
Same day discharge, Trans-radial, Coronary artery stenting, Abciximab bolus
Medical subject headings
Coronary Artery Disease, Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbciximabDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death, Q & non-Q myocardial infarction (MI), urgent revascularization, repeat hospitalization, severe thrombocytopenia, access site complications, major bleedings, at 30-days.

Secondary outcomes (1)

  1. Death, Q & non-Q MI, repeat target vessel revascularization at 30-days, 6 and 12 mo. Length of hospital stay & unsolicited medical visits at 30-days. Patient satisfaction within 24 hrs and at 30 days, 6 and 12 mo. Direct/indirect cost.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Study completionApr 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169819
Sponsor's protocol ID
H4S-CA-0050
Other IDs
ISRCTN72335887
Status last verified
Feb 2007
First submitted
9 Sep 2005
Last updated
26 Feb 2007
Results posted
No
Data monitoring committee
Yes

Publications

  • Bertrand OF, De Larochelliere R, Rodes-Cabau J, Proulx G, Gleeton O, Nguyen CM, Dery JP, Barbeau G, Noel B, Larose E, Poirier P, Roy L; Early Discharge After Transradial Stenting of Coronary Arteries Study Investigators. A randomized study comparing same-day home discharge and abciximab bolus only to overnight hospitalization and abciximab bolus and infusion after transradial coronary stent implantation. Circulation. 2006 Dec 12;114(24):2636-43. doi: 10.1161/CIRCULATIONAHA.106.638627. Epub 2006 Dec 4.

    PubMed 17145988

  • Rinfret S, Kennedy WA, Lachaine J, Lemay A, Rodes-Cabau J, Cohen DJ, Costerousse O, Bertrand OF. Economic impact of same-day home discharge after uncomplicated transradial percutaneous coronary intervention and bolus-only abciximab regimen. JACC Cardiovasc Interv. 2010 Oct;3(10):1011-9. doi: 10.1016/j.jcin.2010.07.011.

    PubMed 20965458

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Abciximab in people with Coronary Artery Disease and Ischemia, run by Laval University at 1 site in Canada.

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 26 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 26 Feb 2007. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Death, Q & non-Q myocardial infarction (MI), urgent revascularization, repeat hospitalization, severe thrombocytopenia, access site complications, major bleedings, at 30-days.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169819, which also lists 2 linked publications.

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 26 Feb 2007.

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