Trial Review

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
ACTRN12607000541404
Ethics application status
Approved
Date submitted
19/10/2007
Date registered
22/10/2007
Date last updated
26/11/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomized, Double-Blind, Placebo-Controlled study to determine the safety and tolerability of E5555, and its Effects on Markers of Inflammation in Subjects with Coronary Artery Disease
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease
Universal Trial Number (UTN)
Trial acronym
LANCELOT CAD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 2372 0
Condition category
Condition code
Cardiovascular 2477 2477 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
E5555 will be administered orally (po), once daily from day 1 to day 168 (week 24). E5555 50 mg (one 50 mg active and two 100 mg placebo tablets). E5555 100 mg (one 50 mg placebo, one 100 mg active, and one 100 mg placebo tablet). E5555 200 mg (one 50 mg placebo and two 100 mg active tablets) Control arm: Placebo (one 50 mg placebo and two 100 mg placebo tablets)
Intervention code [1] 2094 0
Treatment: Drugs
Comparator / control treatment
Placebo (one 50 mg placebo and two 100 mg placebo tablets)
Control group
Placebo

Outcomes
Primary outcome [1] 3487 0
The primary outcome measurement are the major bleeding events and time to event
Timepoint [1] 3487 0
Weeks 1, 2, 4, 8, 12, 16, 20, 24 and 28
Secondary outcome [1] 5823 0
The secondary outcome measurement are the Major Adverse Cardiovascular Events
Timepoint [1] 5823 0
Weeks 1, 2, 4, 8, 12, 16, 20, 24 and 28

Eligibility
Key inclusion criteria
The study will include men and women, aged between 45 and 80 years, inclusive, who have confirmed coronary artery disease defined as post-acute coronary syndrome (ACS) (> 4weeks); or myocardial infarction (MI) (>4 weeks) or Post percutaneous coronary intervention (PCI) (> 4 weeks) or coronary artery bypass surgery (CABG) (>12 weeks); or angina pectoris with documented (electrocardiogram or imaging study) ischemia; or angiographically documented lesion occluding =70% of a coronary vessel. Subjects must be at high risk as defined by meeting one or more of the following: Screening high-sensitivity c-reactive protein (hsCRP) = 3.0 mg/L, history of diabetes mellitus, under Rx treatment, documented history of peripheral arterial disease, documented history of thrombo-embolic transient ischemic attack (TIA) or stroke > 1 year prior to screening, documented history of carotid artery disease. All subjects must be receiving low dose aspirin (75-325 mg) and/or clopidogrel 75 mg once daily and/or ticlopidine 250 mg twice daily.
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability or unwillingness to provide fully informed consent to study participation; pregnancy; any history of a bleeding type condition or disorder; severe heart failure or heart rhythm problems; any cardiac surgery within the 12 weeks before admission or any cardiac event, such as heart attack or unstable angina, within the 30 days prior to admission; unstable diabetes requiring frequent alterations to prescribed anti-diabetic medication; any history of liver or kidney problems which causes significant abnormal blood results; the use of any medications shown to have potential adverse interactions with the study medication; recent significant infection or history of chronic infections requiring continuous antibiotic treatment; history of cancer unless adequate treated with no evdence of disease for at least 2 years and participation in any other clinical trial within the 30 days prior to admission.

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 - patients will be randomised through phone and fax via IVRS (Interactive Voice Response System)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be assigned to one of four treatment groups according to a computerized randomization schedule. The clinical site will then randomize patients according to drug kit number generated via an Interactive Voice Response System (IVRS).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 434 0
NSW, Victoria, SA, WA, Queensland
Recruitment outside Australia
Country [1] 494 0
United States of America
State/province [1] 494 0
Argentina, Belgium, Brazil, Canada, Czech Republic, Germany, Hungary, Ireland, Israel, Netherlands, Poland, South Africa, UK, US
Country [2] 495 0
United States of America
State/province [2] 495 0

Funding & Sponsors
Funding source category [1] 2731 0
Commercial sector/Industry
Name [1] 2731 0
Eisai Limited
Country [1] 2731 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisai Limited
Address
3 Shortlands
London W6 8EE
UK
Country
United Kingdom
Secondary sponsor category [1] 2467 0
Commercial sector/Industry
Name [1] 2467 0
PRA International ANZ
Address [1] 2467 0
Suite 1701 Central Square
323 Castlereagh Street
Sydney NSW 2000
Country [1] 2467 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4648 0
Redcliffe- Caboolture Health Service District HREC
Ethics committee address [1] 4648 0
Redcliffe Hospital
Level 2, Anzac Avenue
Redcliffe Qld 4020
Ethics committee country [1] 4648 0
Australia
Date submitted for ethics approval [1] 4648 0
12/09/2007
Approval date [1] 4648 0
12/10/2007
Ethics approval number [1] 4648 0
N/A

Summary
Brief summary
E5555 is a small molecule that inhibits activation of PAR-1, the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for CAD and not a replacement for any currently established forms of treatment for CAD. This study will look at the safety and tolerability of E5555 in CAD patients for a period of 24 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be up to 31 weeks, to allow for a maximum 3 weeks screening period. The patient would be asked to attend clinic for a total of 11 visits over the course of the study, with visits being between 1 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, ECGs (up to 11 in total); blood tests (up to 11 in total) and regular intake of study medication (three tablets taken once a day with breakfast). Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail 3 additional visits and several additional blood samples being taken for pharmacokinetic and pharmacodynamic purposes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27768 0
Address 27768 0
Country 27768 0
Phone 27768 0
Fax 27768 0
Email 27768 0
Contact person for public queries
Name 10854 0
Anandita Roy
Address 10854 0
PRA International, Suite 1701 Central Square 323 Castlereagh Street Sydney NSW 2000
Country 10854 0
Australia
Phone 10854 0
+61 2 9289 8504
Fax 10854 0
+61 2 9289 8501
Email 10854 0
[email protected]
Contact person for scientific queries
Name 1782 0
Anandita Roy
Address 1782 0
PRA International, Suite 1701 Central Square 323 Castlereagh Street Sydney NSW 2000
Country 1782 0
Australia
Phone 1782 0
+61 2 9289 8504
Fax 1782 0
+61 2 9289 8501
Email 1782 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.