Coronary artery disease Circulatory System Ischaemic heart diseases
Conditions
Interventions
Provisional bivalirudin versus provisional Abciximab following bolus heparin (65 u/kg) during PCI. The trial anticoagulant is given as per normal protocol, i.e., Bivalirudin bolus 0.75 mg/kg followed
Sponsors
University Hospitals of Leicester NHS Trust (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Patients undergoing planned elective PCI at Leicester Glenfield Hospital without requirement for up-front GlycoProtein (GP) IIb IIIa after consent from patient and operator, randomised when Bail out situation is deemed to have occurred by the operator, which requires additional anticoagulation. There will be no limitation of concomitant therapy. All therapeutic regimens will be documented on the Case Report Form (CRF). Indications for additional anticoagulation (and hence randomisation) will include but not be restricted to: 1. Abrupt or side-branch closure 2. Obstructive dissection 3. New or suspected thrombus 4. Impaired or slow coronary blood flow 5. Distal embolisation of thrombus 6. Persistent residual stenosis 7. Unplanned stent placement 8. Prolonged ischaemia 9. Other clinical instability or at discretion of the operator
Exclusion criteria
Exclusion criteria: 1. Any contra-indication to Bivalirudin or ReoPro as per product licence 2. Primary PCI for acute myocardial infarction 3. Uncontrolled sustained Blood Pressure (BP) more than 200/110 mmHg 4. Previous PCI within one month 5. Active bleeding, surgery, trauma or Gastro-Intestinal (GI) bleeding within 6/52 6. Serious intracranial pathology or previous bleed 7. Disseminated malignancy 8. Potential bleeding diathesis or other contra-indication to anticoagulation 9. Platelet count less than 100 10. Serum creatinine more than 350 or dialysis dependent 11. Abciximab within seven days, eptifibitide or tirofiban within 12 hours 12. Any other medical condition, or the presence of extreme age or general frailty which would lead operator to reduce dose or omit anticoagulants in normal practice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major and minor bleeding complication rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major Adverse Coronary Events (MACE) 2. Peri-procedural Troponin T level | — |
Countries
United Kingdom
Outcome results
None listed