Trial Review

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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
Date results information 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
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.
Secondary ID [1] 1403 0
None
Universal Trial Number (UTN)
Trial acronym
RESCUE PCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
STEMI 252187 0
Condition category
Condition code
Cardiovascular 252385 252385 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 241543 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 253257 0
ACUITY (major and minor) bleeding at 30 days.
Timepoint [1] 253257 0
30 days following randomisation.
Secondary outcome [1] 262243 0
Infarct size assessed as the area under the curve (AUC) of creatine kinase-myocardial band isoenzyme (CKMB) levels.
Timepoint [1] 262243 0
Infarct size assessed following randomisation and before discharge from hospital.

Eligibility
Key inclusion criteria
1. Patients with STEMI presenting within 12 hours of onset of symptoms
2. Administration of fibrinolytic therapy and failed reperfusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2010
Actual
9/08/2010
Date of last participant enrolment
Anticipated
Actual
7/07/2015
Date of last data collection
Anticipated
Actual
7/10/2015
Sample size
Target
410
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244012 0
Commercial sector/Industry
Name [1] 244012 0
The Medicines Company
Country [1] 244012 0
United States of America
Primary sponsor type
Individual
Name
Professor John French
Address
Liverpool Hospital
Department of Cardiology
Elizabeth St, Liverpool
NSW 2170
Country
Australia
Secondary sponsor category [1] 251363 0
None
Name [1] 251363 0
Address [1] 251363 0
Country [1] 251363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244119 0
Ethics committee address [1] 244119 0
Ethics committee country [1] 244119 0
Date submitted for ethics approval [1] 244119 0
18/12/2009
Approval date [1] 244119 0
09/07/2010
Ethics approval number [1] 244119 0
Ethics committee name [2] 309859 0
Concord Repatriation General Hospital Human Research Ethics Committee
Ethics committee address [2] 309859 0
Hospital Rd, Concord NSW 2139, Sydney.
Ethics committee country [2] 309859 0
Australia
Date submitted for ethics approval [2] 309859 0
18/12/2009
Approval date [2] 309859 0
09/07/2010
Ethics approval number [2] 309859 0
10/09/CRGH/241

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30505 0
Address 30505 0
Country 30505 0
Phone 30505 0
Fax 30505 0
Email 30505 0
Contact person for public queries
Name 13752 0
John French
Address 13752 0
Department of Cardiology
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
Country 13752 0
Australia
Phone 13752 0
+61 2 9828 3000
Fax 13752 0
Email 13752 0
j.french@unsw.edu.au
Contact person for scientific queries
Name 4680 0
John French
Address 4680 0
Department of Cardiology
Liverpool Hospital
Locked Bag 7103
Liverpool BC
NSW 1871
Country 4680 0
Australia
Phone 4680 0
+61 2 9828 3000
Fax 4680 0
Email 4680 0
j.french@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseReperfusion after Fibrinolytic Therapy (RAFT): An open-label, multi-centre, randomised controlled trial of bivalirudin versus heparin in rescue percutaneous coronary intervention.2021https://dx.doi.org/10.1371/journal.pone.0259148
N.B. These documents automatically identified may not have been verified by the study sponsor.