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Trial registered on ANZCTR
Registration number
ACTRN12610000152022
Ethics application status
Approved
Date submitted
12/11/2009
Date registered
15/02/2010
Date last updated
17/11/2021
Date data sharing statement initially provided
17/11/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Rescue percutaneous coronary intervention (PCI) after fibrinolytics for the treatment of heart attack
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Scientific title
Randomised clinical trial to evaluate ACUITY bleeding rates in ST elevation myocardial infarction (STEMI) patients undergoing rescue percutaneous coronary intervention (PCI) post failed fibrinolysis, treated with bivalirudin or heparin and a glycoprotein IIb/IIIa inhibitor.
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Secondary ID [1]
1403
0
None
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Universal Trial Number (UTN)
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Trial acronym
RESCUE PCI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
STEMI
252187
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Condition category
Condition code
Cardiovascular
252385
252385
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0
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment with bivalirudin (Angiomax). The recommended dosage of Angiomax for patients undergoing PCI is an intravenous (IV) bolus dose of 0.75 mg/kg followed by an IV infusion at a rate of 1.75 mg/kg/hour for the duration of the procedure, or for up to four hours post-PCI, as clinically indicated.
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Intervention code [1]
241543
0
Treatment: Drugs
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Comparator / control treatment
Herparin plus one of 3 glycoprotein IIb/IIIa inhibitors (abciximab, eptifibatide or tirofiban). The dose of heparin will be tailored to the clinical setting. In patients undergoing PCI, target activated clotting time (ACT) may be as low as 200 seconds with adjunctive IIb/IIIa inhibitors and this can be achieved with a weight adjusted heparin bolus at 30–70 U/kg heparin. Abciximab will be given as 0.25 mg/kg bolus 10-60 min before intervention, then 0.125mcg/kg/min (max 10 mcg/min) continuous infusion for 12 hrs. Eptifibatide is given as an intravenous bolus of 180 microgram/kg administered immediately prior to the procedure, followed by a second bolus of 180 microgram/kg ten minutes after the first bolus injection. Simultaneously with the first bolus, a continuous infusion should be started at a dose of 1.0 -2.0 microgram/kg/minute. The infusion is continued until hospital discharge or up to a maximum of 18 to 24 hours post-PCI. A minimum of 12 hours of infusion is recommended. Tirofiban is administered intravenously, initially at 0.4 mcg/kg/min for 30 min; then 0.1 mcg/kg/min; usual duration is 48-108 hours. The infusion may continue through angiography and up to 12-24 hours.
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Control group
Active
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Outcomes
Primary outcome [1]
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ACUITY (major and minor) bleeding at 30 days.
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Assessment method [1]
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Timepoint [1]
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30 days following randomisation.
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Secondary outcome [1]
262243
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Infarct size assessed as the area under the curve (AUC) of creatine kinase-myocardial band isoenzyme (CKMB) levels.
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Assessment method [1]
262243
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Timepoint [1]
262243
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Infarct size assessed following randomisation and before discharge from hospital.
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Eligibility
Key inclusion criteria
1. Patients with STEMI presenting within 12 hours of onset of symptoms
2. Administration of fibrinolytic therapy and failed reperfusion
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Contraindication to fibrinolytic therapy
2. Known hypersensitivity or contraindication to bivalirudin, heparin or glycoprotein inhibitors (GPI).
3. Severe renal impairment
4. Inability to give informed consent
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/04/2010
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Actual
9/08/2010
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Date of last participant enrolment
Anticipated
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Actual
7/07/2015
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Date of last data collection
Anticipated
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Actual
7/10/2015
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Sample size
Target
410
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
244012
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Commercial sector/Industry
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Name [1]
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The Medicines Company
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Address [1]
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8 Sylvan Way, Parsippany, NJ 07054
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Country [1]
244012
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United States of America
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Primary sponsor type
Individual
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Name
Professor John French
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Address
Liverpool Hospital
Department of Cardiology
Elizabeth St, Liverpool
NSW 2170
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Country
Australia
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Secondary sponsor category [1]
251363
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None
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Name [1]
251363
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Address [1]
251363
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Country [1]
251363
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
244119
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Ethics committee address [1]
244119
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Ethics committee country [1]
244119
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Date submitted for ethics approval [1]
244119
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18/12/2009
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Approval date [1]
244119
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09/07/2010
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Ethics approval number [1]
244119
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Ethics committee name [2]
309859
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Concord Repatriation General Hospital Human Research Ethics Committee
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Ethics committee address [2]
309859
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Hospital Rd, Concord NSW 2139, Sydney.
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Ethics committee country [2]
309859
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Australia
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Date submitted for ethics approval [2]
309859
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18/12/2009
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Approval date [2]
309859
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09/07/2010
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Ethics approval number [2]
309859
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10/09/CRGH/241
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Summary
Brief summary
The purpose of this study is to determine which of two different intravenous anticoagulant strategies, currently in clinical use, is the safest and will have less associated bleeding complications. The study aims to test the hypothesis that use of bivalirudin has a lower rate of bleeding complications compared to heparin and glycoprotein IIb/IIIa inhibitor use.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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John French
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Address
13752
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Department of Cardiology
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
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Country
13752
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Australia
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Phone
13752
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+61 2 9828 3000
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Fax
13752
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Email
13752
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[email protected]
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Contact person for scientific queries
Name
4680
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John French
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Address
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Department of Cardiology
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
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Country
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Australia
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Phone
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+61 2 9828 3000
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Fax
4680
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Reperfusion after Fibrinolytic Therapy (RAFT): An open-label, multi-centre, randomised controlled trial of bivalirudin versus heparin in rescue percutaneous coronary intervention.
2021
https://dx.doi.org/10.1371/journal.pone.0259148
N.B. These documents automatically identified may not have been verified by the study sponsor.
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