Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000232538
Ethics application status
Approved
Date submitted
16/01/2006
Date registered
7/06/2006
Date last updated
9/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The early use of IV (Intra venous)verapamil and nitrates in Acute Myocardial Infarction (AMI)
Scientific title
The early use of Intra Venous verapamil and nitrates and the effects on angiographic patency and infarct size in Acute Myocardial Infarction
Universal Trial Number (UTN)
Trial acronym
IVANA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute ST segment elevation myocardial infarction requiring urgent revascularisation (angioplasty or stent). The ST segment refers to that of QRST complex as represented on a 12 lead ECG(electrocardiogragh) 1210 0
Condition category
Condition code
Cardiovascular 1295 1295 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IV verapamil 2 mg over 5 minutes or saline placebo and glyceryl trinitrate infusion 5mcg per minute( 8 mls per hour) and the patient has given informed consent.
Intervention code [1] 840 0
Treatment: Drugs
Comparator / control treatment
Corresponding saline placebo is administered as soon as the decision for acute intervention(angioplasty or stent) has been made
Control group
Placebo

Outcomes
Primary outcome [1] 1769 0
Angiographic TIMI-3 (term used to state that blood flow through coronary artery is back to normal) flow at time of angiograghy
Timepoint [1] 1769 0
An Xray -angiogram-is taken of the coronary artery at the start of the procedure to see which arteies are blocked and need an angioplasty or stent and which ones are open and do not require treatment.
Secondary outcome [1] 3116 0
Angiographic patency and infarct size measured at time of angiography.(An Xray- angiogram- is taken of the coronary artery at the start of the procedure to see which arteies are blocked and need an angioplasty or stent and which ones are open and do not require treatment).
Timepoint [1] 3116 0

Eligibility
Key inclusion criteria
Acute ST segment elevation myocardial infarction(STEMI) with primary Percutaneous Coronary Intervention.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Contraindications to verapamil/glyceryl trinitrate.

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)
Blinded,numbered and sealed treatment boxes allocated by number sequential randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1421 0
Charities/Societies/Foundations
Name [1] 1421 0
National Heart Foundation of Australia Grant in Aid
Country [1] 1421 0
Australia
Primary sponsor type
Hospital
Name
The Queen Elizabeth Hospital,Cardiology Unit
Address
Adelaide SA
Country
Australia
Secondary sponsor category [1] 1249 0
None
Name [1] 1249 0
Nil
Address [1] 1249 0
Country [1] 1249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2787 0
The Queen Elizabethn Hospital,Cardiology Unit
Ethics committee address [1] 2787 0
AdelaideSA
Ethics committee country [1] 2787 0
Australia
Date submitted for ethics approval [1] 2787 0
Approval date [1] 2787 0
24/02/2005
Ethics approval number [1] 2787 0
Ethics committee name [2] 2788 0
The Lyell McEwin Health Service
Ethics committee address [2] 2788 0
Adelaide SA
Ethics committee country [2] 2788 0
Australia
Date submitted for ethics approval [2] 2788 0
Approval date [2] 2788 0
06/10/2005
Ethics approval number [2] 2788 0
Ethics committee name [3] 2789 0
Flinders Medical Centre
Ethics committee address [3] 2789 0
Adelaide
Ethics committee country [3] 2789 0
Australia
Date submitted for ethics approval [3] 2789 0
Approval date [3] 2789 0
Ethics approval number [3] 2789 0
Ethics committee name [4] 2790 0
Royal Adelaide Hospital
Ethics committee address [4] 2790 0
Adelaide
Ethics committee country [4] 2790 0
Australia
Date submitted for ethics approval [4] 2790 0
Approval date [4] 2790 0
Ethics approval number [4] 2790 0

Summary
Brief summary
To assess if the early use of verapamil and Glyceryl trinitrate improves TIMI 3 flow(term used to state that blood flow through coronary artery is back to normal)Only the study pharmacist was unblinded to treatment allocation. Study drug was sealed in a box and allocated a number in lots of 10. Study staff would allocate the sealed box to the patient by number sequence. All study personel and persons involved in the clinical management of the patient were also blinded to treatment allocation.Emergency unblinding was available if required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35225 0
Address 35225 0
Country 35225 0
Phone 35225 0
Fax 35225 0
Email 35225 0
Contact person for public queries
Name 10029 0
Dr John Beltrame
Address 10029 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 10029 0
Australia
Phone 10029 0
+61 8 82226000
Fax 10029 0
+61 8 82227021
Email 10029 0
[email protected]
Contact person for scientific queries
Name 957 0
Dr John Beltrame
Address 957 0
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 957 0
Australia
Phone 957 0
+61 8 82226000
Fax 957 0
+61 8 82227021
Email 957 0
[email protected]

No information has been provided regarding IPD availability


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
Dimensions AIRole of Coronary Vasoconstriction in Ischemic Heart Disease and Search for Novel Therapeutic Targets2009https://doi.org/10.1253/circj.cj-09-0033
N.B. These documents automatically identified may not have been verified by the study sponsor.