Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000343505
Ethics application status
Approved
Date submitted
30/03/2006
Date registered
11/08/2006
Date last updated
4/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
CHAMPION PCI
Scientific title
A Clinical trial comparing Cangrelor
to Clopidogrel in subjects who require percutaneous coronary intervention (PCI) to demonstrate that cangrelor is superior, or at least non-inferior, to that of clopidogrel as measured by a composite of all-cause mortality, myocardial infarction (MI) and ischaemia driven revascularisation (IDR).
Universal Trial Number (UTN)
Trial acronym
CHAMPION PCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unstable Angina 1312 0
Myocardial Infarction 1313 0
Acute Coronary Syndromes 1314 0
Condition category
Condition code
Cardiovascular 1399 1399 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects who fulfill the criteria and are to under go PCI will be randomised on a 1:1 randomisation to receive either 4 placebo capsules orally plus Cangrelor bolus (30ug/kg) & infusion (4 ug/kg/min) for at least 2 hours or the duration of the procedure, whichever is longer. Post infusion be administered 4 Clopidogrel capsules (600mg) orally once. The other group would receive 4 Clopidogrel capsules (600mg) plus Placebo bolus (30 ug/kg) and infusion (4 ug/kg/min) for the duration of the procedure or 2 hours whichever is longer. At the end of the infusion they will receive 4 placebo capsules once. Clopidogrel maintenance is at the physicians discretion.
Intervention code [1] 964 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Active

Outcomes
Primary outcome [1] 1914 0
All cause mortality
Timepoint [1] 1914 0
In the 48 hours after randomisation
Primary outcome [2] 1915 0
Myocardial Infaction
Timepoint [2] 1915 0
In the 48 hours after randomisation
Primary outcome [3] 1916 0
Ischaemic driven revascularization
Timepoint [3] 1916 0
In the 48 hours after randomisation
Secondary outcome [1] 3373 0
All cause mortality and myocardial infarction
Timepoint [1] 3373 0
At 30 days.

Eligibility
Key inclusion criteria
Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation and one of the following:
1. Non ST segment myocardial infarction with Troponin I or T greater than upper limit of normal within 24 hours of randomisation.
2. Unstable angina with ischaemic chest discomfort occurring at rest and lasting longer than 10 minutes within 24 hours of randomisation and with dynamic ECG changes with age greater than 65 years or diabetes.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Glycoprotein IIb/IIIa (GPI) Inhibitor usuage within the previous 12 hours.

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)
Central randomisation by phone/fax
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software(ie computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Active control
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
9000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1533 0
Commercial sector/Industry
Name [1] 1533 0
The Medicines Company
Country [1] 1533 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
The Medicines Company
Address
8 Campus Drive
Parsippany, NJ 07054
Country
United States of America
Secondary sponsor category [1] 1347 0
Hospital
Name [1] 1347 0
Flinders Medical Centre
Address [1] 1347 0
1 Flinders Drive
Bedford Park SA 5042
Country [1] 1347 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2956 0
Flinders Medical Centre
Ethics committee address [1] 2956 0
Ethics committee country [1] 2956 0
Australia
Date submitted for ethics approval [1] 2956 0
Approval date [1] 2956 0
Ethics approval number [1] 2956 0
TMC-CAN-05-02
Ethics committee name [2] 2957 0
Royal Adelaide Hospital
Ethics committee address [2] 2957 0
Ethics committee country [2] 2957 0
Australia
Date submitted for ethics approval [2] 2957 0
Approval date [2] 2957 0
Ethics approval number [2] 2957 0
TMC-CAN-05-02
Ethics committee name [3] 2958 0
The Queen Elizabeth Hospital
Ethics committee address [3] 2958 0
Ethics committee country [3] 2958 0
Australia
Date submitted for ethics approval [3] 2958 0
Approval date [3] 2958 0
Ethics approval number [3] 2958 0
TMC-CAN-05-02
Ethics committee name [4] 2959 0
Holy Spirit Hospital
Ethics committee address [4] 2959 0
Ethics committee country [4] 2959 0
Australia
Date submitted for ethics approval [4] 2959 0
Approval date [4] 2959 0
Ethics approval number [4] 2959 0
TMC-CAN-05-02
Ethics committee name [5] 2960 0
The Canberra Hospital
Ethics committee address [5] 2960 0
Ethics committee country [5] 2960 0
Australia
Date submitted for ethics approval [5] 2960 0
Approval date [5] 2960 0
Ethics approval number [5] 2960 0
TMC-CAN-05-02
Ethics committee name [6] 2961 0
Royal Brisbane
Ethics committee address [6] 2961 0
Ethics committee country [6] 2961 0
Australia
Date submitted for ethics approval [6] 2961 0
Approval date [6] 2961 0
Ethics approval number [6] 2961 0
TMC-CAN-05-02

Summary
Brief summary
Each year over 1 million patients globally undergo diagnostic angiography and are discovered to have atherosclerotic plaque amenable to percutaneous coronary intervention (PCI). This area has been extensively researched and benefit shown with the use of aspirin, and more recently 300mg loading dose and 75mg maintenance dose of clopidogrel. Despite the apparent benefit, many patients still do not receive a loading dose (either deliberately – as there is a reasonable probability of being triaged to CABG) or because there is insufficient time (stable patients undergoing diagnostic angiogram who proceed immediately to PCI). Cangrelor is a new drug being developed, which in early phase trials appears to be safe and well tolerated & will provide platelet inhibition throughout the infusion with full recovery of platelet function within 60min of stopping the infusion. This trial aims to demonstrate the efficacy of cangrelor compared to clopidogrel in patients requiring PCI. The primary endpoints to be measured will be all cause mortality, myocardial infarction (MI) and ischemia driven reinfarction (IDR) at 48hrs and 1 month, then mortality at 1year. This study will employ double blind and double dummy tachniques in addition to an active control. Subjects, Investigators, Study Monitor, Data Analyst and the sponsor The Medicines Company will be blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35146 0
Address 35146 0
Country 35146 0
Phone 35146 0
Fax 35146 0
Email 35146 0
Contact person for public queries
Name 10153 0
Ms Caroline Thomas
Address 10153 0
Cardiology Research
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 10153 0
Australia
Phone 10153 0
+61 8 82044440
Fax 10153 0
+61 8 82045000
Email 10153 0
[email protected]
Contact person for scientific queries
Name 1081 0
Associate Professor Derek Chew
Address 1081 0
Cardiac Services
Flinders Medical Centre
Bedford Park SA 5042
Country 1081 0
Australia
Phone 1081 0
+61 8 84042001
Fax 1081 0
+61 8 84042150
Email 1081 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.