Contact information
Type
Scientific
Primary contact
Dr Olivier Bertrand
ORCID ID
Contact details
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
+1 418 656 8711 ext 3136
olivier.bertrand@crhl.ulaval.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00169819
Protocol/serial number
H4S-CA-0050
Study information
Scientific title
Acronym
EArly discharge after trans-radial Stenting of coronarY arteries: The EASY study
Study hypothesis
1. Discharge on the same day after uncomplicated trans-radial coronary artery stenting is safe and effective.
2. Hospitalized patients can be safely returned to the referring center the same day following trans-radial coronary artery stenting.
3. 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.
4. Same-day discharge is cost-effective and increases patient satisfaction.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Angina
Intervention
Patients with stable or unstable angina referred for catheterization and possible percutaneous intervention are eligible.
After diagnostic trans-radial catheterization, patients receive a bolus of Abciximab and undergo dilatation and stent implantation. At the end of the uncomplicated procedure, patients are randomized between group 1: No perfusion of Abciximab and discharge 4-6 hours after PCI and group 2: Standard 12 hours Abciximab perfusion and overnight hospitalization. In case of complications, patients are included in a registry and receive standard 12 hours Abciximab perfusion. Electrocardiogram (ECG) and biology tests (creatine kinase [CK] CK-myocardial band [CK-MB], troponins) are performed before, 4-6 hours after and the next day after PCI. Clinical follow-up is performed at 24 hours, 30 days, 6 months and 1 year after PCI.
Intervention type
Drug
Phase
Not Specified
Drug names
Abciximab
Primary outcome measures
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.
Secondary outcome measures
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.
Overall trial start date
15/10/2003
Overall trial end date
29/04/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Approximately 1000 patients undergoing 'adhoc' percutaneous coronary intervention (PCI) will be randomized.
Inclusion Criteria:
1. Patients with documented ischemic coronary artery disease and scheduled for possible coronary artery stenting are eligible.
2. Patient must be >18 years of age.
3. Patient and treating interventional cardiologist agree for randomization.
4. Patient will be informed of the randomization process and will sign an informed consent.
5. Diagnostic and therapeutic intervention performed through trans-radial/ulnar artery approach.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
CLINICAL:
1. Patients with recent (<72 hrs) Q-wave (ST elevation) acute myocardial infarction
2. History of LV ejection fraction ≤30%
3. Unstable clinical condition
4. Any complication compromising ambulation
5. Concurrent participation in other investigational study requiring prolonged hospitalization
6. Required prolonged hospitalization
7. Incath lab transient vessel closure
8. Resuscitation per PCI
9. Hemodynamic collapse during PCI
10. Severe entry site complication upon investigator decision
11. Social isolation
12. Serious cognitive disorders
13. Femoral sheath (artery)
14. Persisting chest pain
15. No ASA prior PCI
16. Allergy to ASA or thienopyridines precluding treatment for 30 days
17. Any significant blood dyscrasia
18. PCI without stent implantation (except for bifurcation lesion or re-dilatation for in-stent restenosis)
19. International Normalised Ratio (INR) >2.0
20. Contraindication to Reopro administration
ANGIOGRAPHIC:
1. Residual dissection of grade ≥B of NHBLI classification
2. Compromised or sub-occluded branch with diameter ≥ 1 mm
3. Timi <3 post-stenting
4. Thrombus post-PCI
Recruitment start date
15/10/2003
Recruitment end date
29/04/2005
Locations
Countries of recruitment
Canada
Trial participating centre
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
Sponsor information
Organisation
Laval Hospital Research Center (Canada)
Sponsor details
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
+1 418 656 8711
olivier.bertrand@crhl.ulaval.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
This Study is an Investigator Initiated Trial, which is supported by unrestricted grants from Eli-Lilly and Bristol-Myers-Squibb (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&dopt=AbstractPlus&list_uids=17145988
Publication citations
-
Results
Bertrand OF, De Larochellière R, Rodés-Cabau J, Proulx G, Gleeton O, Nguyen CM, Déry JP, Barbeau G, Noël B, Larose E, Poirier P, Roy L, , 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, 114, 24, 2636-2643, doi: 10.1161/CIRCULATIONAHA.106.638627.