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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN72335887

Enrollment

1000

Registered

2005-02-04

Start date

2003-10-15

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Circulatory System Angina

Interventions

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 Ab

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: CLINICAL: 1. Patients with recent (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

Design outcomes

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Primary

Measure	Time frame
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.	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026