BAIL-OUT: 'Bail-out Anticoagulation in coronary Intervention TriaL - OUTcomes': a randomised comparison of the real world use of bivalirudin versus abciximab as a 'bail out' anticoagulant following heparin in percutaneous coronary intervention with focus on patient safety

Phase 4

Completed

Conditions: Circulatory System
Coronary artery disease
Ischaemic heart diseases

Registration Number: ISRCTN98978563

Lead Sponsor: niversity Hospitals of Leicester NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

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

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