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

Completed

• Conditions: Angina; Circulatory System

• Registration Number: ISRCTN72335887
• Lead Sponsor: aval Hospital Research Center (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1000

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.