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
| ISRCTN | ISRCTN72335887 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72335887 |
| ClinicalTrials.gov number | NCT00169819 |
| Secondary identifying numbers | H4S-CA-0050 |
- Submission date
- 05/01/2005
- Registration date
- 04/02/2005
- Last edited
- 18/10/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Olivier Bertrand
Scientific
Scientific
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
| Phone | +1 418 656 8711 ext 3136 |
|---|---|
| olivier.bertrand@crhl.ulaval.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single-centre |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | EArly discharge after trans-radial Stenting of coronarY arteries: The EASY study |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Abciximab |
| Primary outcome measure | 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 study start date | 15/10/2003 |
| Completion date | 29/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/10/2003 |
| Date of final enrolment | 29/04/2005 |
Locations
Countries of recruitment
- Canada
Study participating centre
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
G1V 4G5
Canada
Sponsor information
Laval Hospital Research Center (Canada)
Hospital/treatment centre
Hospital/treatment centre
2725 Chemin Ste Foy
Quebec
G1V 4G5
Canada
| Phone | +1 418 656 8711 |
|---|---|
| olivier.bertrand@crhl.ulaval.ca |
Funders
Funder type
Industry
This Study is an Investigator Initiated Trial, which is supported by unrestricted grants from Eli-Lilly and Bristol-Myers-Squibb (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 12/12/2006 | Yes | No |
