Condition category
Circulatory System
Date applied
07/09/2006
Date assigned
04/01/2007
Last edited
09/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Gershlick

ORCID ID

Contact details

Clinical Sciences Department
Glenfield Hospital
Groby Road
Leicester
LE3 9QP
United Kingdom
+44 (0)116 256 3021
agershlick@aol.com

Additional identifiers

EudraCT number

2006-003343-23

ClinicalTrials.gov number

Protocol/serial number

UHL 10145

Study information

Scientific title

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

Acronym

BAIL-OUT

Study hypothesis

Non-inferiority exists in terms of bleeding complication rates between bivalirudin and abciximab (ReoPro) when used as provisional (Bail-out) anticoagulants during Percutaneous Coronary Intervention (PCI).

Ethics approval

LREC approval was granted on 13/10/2006 by Leicestershire, Northamptonshire and Rutland REC 1, ref: 06/Q2501/197

Study design

Single-centre open-label randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

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 by infusion of 1.75 mg/kg/hr for duration of procedure only and Abciximab bolus and infusion for 12 hours.

Data collected from baseline, day of discharge post PCI and 30 days post PCI.

Intervention type

Drug

Phase

Phase IV

Drug names

Bivalirudin, abciximab (ReoPro), heparin

Primary outcome measures

Major and minor bleeding complication rate

Secondary outcome measures

1. Major Adverse Coronary Events (MACE)
2. Peri-procedural Troponin T level

Overall trial start date

01/11/2006

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

50 per group = 100 patients

Participant 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

Recruitment start date

01/11/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glenfield Hospital
Leicester
LE3 9QP
United Kingdom

Sponsor information

Organisation

University Hospitals of Leicester NHS Trust (UK)

Sponsor details

c/o Professor David Rowbotham
Trust Headquarters
Gwendolen House
Gwendolen Road
Leicester
LE5 4QF
United Kingdom
+44 (0)115 249 0490
djr8@le.ac.uk

Sponsor type

Government

Website

http://www.uhl-tr.nhs.uk/

Funders

Funder type

Government

Funder name

Departmental funding from the University Hospitals of Leicester NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nycomed UK Ltd (UK) will provide a small research grant (to cover consumables and admin costs); Nycomed have no rights to any future publications or input into design or conduct of the study

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes