Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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
ACTRN12607000544471
Ethics application status
Not yet submitted
Date submitted
19/10/2007
Date registered
23/10/2007
Date last updated
20/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
"A Randomised, Double-Blind, Placebo-Controlled study to determine the safety and tolerability of E5555 in patients admitted to hospital with symptoms of Acute Coronary Syndrome"
Scientific title
A Randomised, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Clinical Events and Biomarkers in Patients with Non-ST-Segment Elevation Acute Coronary Syndrome
Universal Trial Number (UTN)
Trial acronym
LANCELOT ACS (Acute Coronary Syndrome)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 2371 0
Condition category
Condition code
Cardiovascular 2476 2476 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After a single, orally administered, loading dose of E5555 400 mg on day 1 (four 100 mg active tablets) or placebo 400 mg (four 100 mg placebo tablets), E5555 will be administered orally (po), once daily from day 2 to day 84 (week 12). 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) and 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] 2093 0
Treatment: Drugs
Comparator / control treatment
Control arm:
Placebo (one 50 mg placebo and two 100 mg placebo tablets)
Control group
Placebo

Outcomes
Primary outcome [1] 3484 0
Primary outcome measurement are the major bleeding events and time to event
Timepoint [1] 3484 0
Daily during the hospitalization period and at weeks 2, 4, 8, 12 and 16
Secondary outcome [1] 5816 0
The secondary outcome measurement are the Major Adverse Cardiovascular Events
Timepoint [1] 5816 0
Daily during the hospitalization period and at weeks 2, 4, 8, 12 and 16

Eligibility
Key inclusion criteria
The study will include men and women, aged between 45 and 80 years, inclusive, who have been admitted to hospital with a diagnosis of non-ST segment elevation Acute Coronary Syndrome (ACS). There must be symptoms typical of unstable angina, and able to be randomised and treated within 24 hours of the onset of the pain resulting in this admission. In addition to this, cardiac enzymes must be elevated or electrocardiogram (ECG) changes compatible with ischemia must be present
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 computerised randomisation schedule. The clinical site will then randomise 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
Subject, investigator and sponsor will be kept blinded in the study
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2007
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] 433 0
NSW, Victoria, Queensland, SA, WA
Recruitment outside Australia
Country [1] 506 0
United States of America
State/province [1] 506 0
South Africa, South America, Israel, Europe, the US, Canada and Australia
Country [2] 507 0
United States of America
State/province [2] 507 0

Funding & Sponsors
Funding source category [1] 2622 0
Commercial sector/Industry
Name [1] 2622 0
Eisai Limited
Country [1] 2622 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Eisai Ltd
Address
3 Shortlands
London W6 8EE
UK
Country
United Kingdom
Secondary sponsor category [1] 2371 0
Commercial sector/Industry
Name [1] 2371 0
Pharmaceutical Research Associates Ltd
Address [1] 2371 0
Level 17
Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country [1] 2371 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4646 0
North Coast Area HS EC
Ethics committee address [1] 4646 0
North Coast Area Health Service
PO Box 126
PORT MACQUARIE NSW 2444
Australia
Ethics committee country [1] 4646 0
Australia
Date submitted for ethics approval [1] 4646 0
27/09/2007
Approval date [1] 4646 0
Ethics approval number [1] 4646 0
MNC 02/02

Summary
Brief summary
E5555 is a small molecule that inhibits activation of protease-activated receptor 1 (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 Acute Coronary Syndrome (ACS) and not a replacement for any currently established forms of treatment for Acute Coronary Syndrome (ACS). This study will look at the safety and efficacy of E5555 in patients admitted to hospital with symptoms, and objective evidence, of acute coronary syndrome, for a period of 12 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be 16 weeks. The patients would be seen initially on a daily basis during the hospitalisaiton period, and once discharged, asked to attend clinic for a total of 5 visits over the outpatient phase of the study. Visits will be between 2 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, electrocardiongrams (up to 11 in total); blood draws (8 in total) and regular intake of study medication (three tables taken once a day with breakfast). Continuous electrocardiogram (ECG) monitoring (Holter monitoring) will also be done for the first 48 hours following randomisation. 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 additional blood samples being taken for pharmacokinetics (PK) and platelet aggregation purposes
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27791 0
Address 27791 0
Country 27791 0
Phone 27791 0
Fax 27791 0
Email 27791 0
Contact person for public queries
Name 10877 0
Nimisha Katariya
Address 10877 0
PRA International
Level 17
Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country 10877 0
Australia
Phone 10877 0
+61 2 9289 8542
Fax 10877 0
+61 2 9289 8501
Email 10877 0
katariyanimisha@praintl.com
Contact person for scientific queries
Name 1805 0
Nimisha Katariya
Address 1805 0
PRA International
Level 17
Suite 1701
323 Castlereagh Street
Sydney NSW 2000
Country 1805 0
Australia
Phone 1805 0
+61 2 9289 8542
Fax 1805 0
+61 2 9289 8501
Email 1805 0
katariyanimisha@praintl.com

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.