Condition category
Circulatory System
Date applied
05/01/2005
Date assigned
04/02/2005
Last edited
18/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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. In–cath 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

  1. 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.

Additional files

Editorial Notes