Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000581662
Ethics application status
Approved
Date submitted
23/07/2005
Date registered
4/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
PRACTICAL TRIAL
Scientific title
Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increase after Coronary intervention in Acute coronary Lesions
Universal Trial Number (UTN)
Trial acronym
PRACTICAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndromes 708 0
Condition category
Condition code
Cardiovascular 785 785 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clopidogrel Loading Dose 300mg vs 600mg
Intervention code [1] 52 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 1001 0
Troponin I elevated above pre-procedure level and at least five times the upper limit of normal within 24 hours of percutaneous coronary intervention
Timepoint [1] 1001 0
Secondary outcome [1] 1888 0
Laboratory measures of clopidogrel and aspirin resistance.
Timepoint [1] 1888 0
Measured immediately prior to coronary intervention.

Eligibility
Key inclusion criteria
1. abnormal electrocardiogram 2. evidence of myonecrosis (elevated troponin I or T above ULN) at presentation.3. known coronary artery disease with previous MI, PCI, CABG surgery, or positive stress test.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software, blocking
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 869 0
Commercial sector/Industry
Name [1] 869 0
Sanofi Australia
Country [1] 869 0
Australia
Primary sponsor type
Hospital
Name
Cardiology Dept, Royal Perth Hospital
Address
Country
Australia
Secondary sponsor category [1] 736 0
None
Name [1] 736 0
Nil
Address [1] 736 0
Country [1] 736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2134 0
Royal Perth Hospital
Ethics committee address [1] 2134 0
Ethics committee country [1] 2134 0
Australia
Date submitted for ethics approval [1] 2134 0
Approval date [1] 2134 0
Ethics approval number [1] 2134 0
Ethics committee name [2] 2135 0
Fremantle Hospital
Ethics committee address [2] 2135 0
Ethics committee country [2] 2135 0
Australia
Date submitted for ethics approval [2] 2135 0
Approval date [2] 2135 0
Ethics approval number [2] 2135 0
Ethics committee name [3] 2136 0
Sir CHarles Gairdner Hospital
Ethics committee address [3] 2136 0
Ethics committee country [3] 2136 0
Australia
Date submitted for ethics approval [3] 2136 0
Approval date [3] 2136 0
Ethics approval number [3] 2136 0
Ethics committee name [4] 2137 0
Royal Melbourne Hospital
Ethics committee address [4] 2137 0
Ethics committee country [4] 2137 0
Australia
Date submitted for ethics approval [4] 2137 0
Approval date [4] 2137 0
Ethics approval number [4] 2137 0
Ethics committee name [5] 2138 0
Epworth Hospital
Ethics committee address [5] 2138 0
Ethics committee country [5] 2138 0
Australia
Date submitted for ethics approval [5] 2138 0
Approval date [5] 2138 0
Ethics approval number [5] 2138 0
Ethics committee name [6] 2139 0
Concorde Hospital
Ethics committee address [6] 2139 0
Ethics committee country [6] 2139 0
Australia
Date submitted for ethics approval [6] 2139 0
Approval date [6] 2139 0
Ethics approval number [6] 2139 0
Ethics committee name [7] 2140 0
Royal Prince Alfred Hospital
Ethics committee address [7] 2140 0
Ethics committee country [7] 2140 0
Australia
Date submitted for ethics approval [7] 2140 0
Approval date [7] 2140 0
Ethics approval number [7] 2140 0
Ethics committee name [8] 2141 0
Liverpool Hospital
Ethics committee address [8] 2141 0
Ethics committee country [8] 2141 0
Australia
Date submitted for ethics approval [8] 2141 0
Approval date [8] 2141 0
Ethics approval number [8] 2141 0
Ethics committee name [9] 2142 0
Flinders Medical Centre
Ethics committee address [9] 2142 0
Ethics committee country [9] 2142 0
Australia
Date submitted for ethics approval [9] 2142 0
Approval date [9] 2142 0
Ethics approval number [9] 2142 0
Ethics committee name [10] 2143 0
Prince Charles Hospital
Ethics committee address [10] 2143 0
Ethics committee country [10] 2143 0
Australia
Date submitted for ethics approval [10] 2143 0
Approval date [10] 2143 0
Ethics approval number [10] 2143 0

Summary
Brief summary
A multi-centre, randomised, double-blind, clinical trial comparing a 600mg versus 300mg loading dose of Clopidogrel on the Incidence of Myonecrosis and Laboratory Measures of Platelet Inhibition following early Percutaneous Coronary Intervention in Acute Coronary Syndrome patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35344 0
Address 35344 0
Country 35344 0
Phone 35344 0
Fax 35344 0
Email 35344 0
Contact person for public queries
Name 9241 0
Dr Jamie Rankin
Address 9241 0
Cardiology Department
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 9241 0
Australia
Phone 9241 0
+61 8 92242067
Fax 9241 0
+61 8 92243175
Email 9241 0
[email protected]
Contact person for scientific queries
Name 169 0
Louise Ferguson
Address 169 0
Cardiology Department
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 169 0
Australia
Phone 169 0
+61 8 92243181
Fax 169 0
+61 8 92242448
Email 169 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
No additional documents have been identified.