Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000405415
Ethics application status
Approved
Date submitted
24/07/2007
Date registered
7/08/2007
Date last updated
18/02/2020
Date data sharing statement initially provided
18/02/2020
Date results information initially provided
18/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes.
Scientific title
A Randomized, Double-Blind, Placebo Controlled, Multicentre, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination with Aspirin Alone or with Aspirin and a Thienopyridine in Subjects with Acute Coronary Syndromes. The ATLAS ACS TIMI 46 Study. 39039039-ACS-2001
Secondary ID [1] 450 0
ClinicalTrials.gov: NCT00402597
Universal Trial Number (UTN)
Trial acronym
ATLAS ACS TIMI 46
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 2193 0
Condition category
Condition code
Cardiovascular 2288 2288 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to evaluate the safety and efficacy of rivaroxaban in subjects with recent Acute Coronary Syndrome who are receiving background low-dose aspirin therapy (75 to 100 mg/day) without the intention to use a thienopyridine therapy or with thienopyridine therapy.

There will be 2 stages. Stage 1 will be for dose escalation while Stage 2 will be for dose confirmation.

In Stage 1 there will be 3 total daily dose levels of rivaroxaban or placebo. 5 mg (2.5 mg twice a day or 5 mg once daily), 10 mg (5 mg twice a day or 10 mg daily) and 20 mg (10 mg twice a day or 20 mg daily). Mode of administration is oral. Two more additional dose levels may be added depending on the safety and efficacy profile observed in the first 3 dose levels. Maximum daily dose will not exceed 30 mg. All randomised subjects are planned to receive 6 months of treatment.

In Stage 2, it is intended that a rivaroxaban once daily dose, twice daily dose or both will be selected for comparison to placebo. The dosage will be dependent upon the maximum tolerable dose for individual patient that was discovered during the dose escalation stage. Treatment will also be for 6 months.
Intervention code [1] 1907 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill) - 1 placebo tablet twice daily for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 3179 0
The number of patients with recent ACS taking rivaroxaban with background antiplatelet therapy who experience protocol-defined clinically significant bleeding (assessed by clinical assessment and optionally imaging procedures or laboratory tests as appropriate).
Timepoint: Day 1 to Day 210
Timepoint [1] 3179 0
The analysis of the outcome will be through to 6 months. The events will be collated as they occur over the 6 months.
Secondary outcome [1] 5303 0
The number of patients who experience death (all cause), MI, (or reMI), stroke, or ischemia requiring revascularization (assessed by clinical assessment and optionally imaging procedures or laboratory tests as appropriate).
Timepoint: Day 1 to Day 210
Timepoint [1] 5303 0
The analysis of the outcome will be through to 6 months. The events will be collated as they occur over the 6 months.

Eligibility
Key inclusion criteria
Have symptoms suggestive of ACS and a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction / unstable angina with at least 1 high risk feature. (ST is a section of the electrocardiograph wave.)
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active bleeding or high risk of bleeding or intracranial haemorrhage.Need for continued anticoagulant therapy.Significantly impaired renal or hepatic function.Severe concomitant diseases such as cardiogenic shock, refractory ventricular arrhythmias, or any severe condition that would limit life expectancy to less than 6 months.

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)
The packaging and dosage will be such that the different treatment groups will appear identical. An interactive voice response system (IVRS) will be used to accomplish a blind allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random code.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a double blind trial, meaning that the subjects receiving the treatment and all the researchers are blinded to the treatments.
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2006
Actual
17/11/2006
Date of last participant enrolment
Anticipated
Actual
21/02/2008
Date of last data collection
Anticipated
Actual
19/09/2008
Sample size
Target
3490
Accrual to date
Final
3490
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 2452 0
Commercial sector/Industry
Name [1] 2452 0
Bayer Australia Limited
Country [1] 2452 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bayer Australia Limited
Address
875 Pacific Highway
Pymble NSW 2073
Country
Australia
Secondary sponsor category [1] 2224 0
Commercial sector/Industry
Name [1] 2224 0
Bayer Australia Limited
Address [1] 2224 0
875 Pacific Highway
Pymble NSW 2073
Country [1] 2224 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4307 0
Royal Perth Hospital
Ethics committee address [1] 4307 0
Perth WA
Ethics committee country [1] 4307 0
Australia
Date submitted for ethics approval [1] 4307 0
Approval date [1] 4307 0
12/02/2007
Ethics approval number [1] 4307 0
RA-07/002
Ethics committee name [2] 4308 0
Concord Repatriation General Hospital
Ethics committee address [2] 4308 0
NSW
Ethics committee country [2] 4308 0
Australia
Date submitted for ethics approval [2] 4308 0
Approval date [2] 4308 0
06/02/2007
Ethics approval number [2] 4308 0
CH62/6/2006-125
Ethics committee name [3] 4309 0
The Prince Charles Hospital
Ethics committee address [3] 4309 0
QLD
Ethics committee country [3] 4309 0
Australia
Date submitted for ethics approval [3] 4309 0
Approval date [3] 4309 0
10/01/2007
Ethics approval number [3] 4309 0
EC2692
Ethics committee name [4] 4310 0
The Queen Elizabeth Hospital
Ethics committee address [4] 4310 0
SA
Ethics committee country [4] 4310 0
Australia
Date submitted for ethics approval [4] 4310 0
Approval date [4] 4310 0
22/01/2007
Ethics approval number [4] 4310 0
2006162
Ethics committee name [5] 4311 0
Geelong Cardiology Research Unit
Ethics committee address [5] 4311 0
VIC
Ethics committee country [5] 4311 0
Australia
Date submitted for ethics approval [5] 4311 0
Approval date [5] 4311 0
13/03/2007
Ethics approval number [5] 4311 0
07/01
Ethics committee name [6] 4312 0
Monash Medical Centre
Ethics committee address [6] 4312 0
VIC
Ethics committee country [6] 4312 0
Australia
Date submitted for ethics approval [6] 4312 0
Approval date [6] 4312 0
19/02/2007
Ethics approval number [6] 4312 0
04189
Ethics committee name [7] 4313 0
Box Hill Hospital
Ethics committee address [7] 4313 0
VIC
Ethics committee country [7] 4313 0
Australia
Date submitted for ethics approval [7] 4313 0
Approval date [7] 4313 0
27/02/2007
Ethics approval number [7] 4313 0
E66/0607
Ethics committee name [8] 4314 0
Fremantle Hospital
Ethics committee address [8] 4314 0
WA
Ethics committee country [8] 4314 0
Australia
Date submitted for ethics approval [8] 4314 0
Approval date [8] 4314 0
01/02/2007
Ethics approval number [8] 4314 0
06/575
Ethics committee name [9] 4315 0
Wesley Research Institute
Ethics committee address [9] 4315 0
8/451 Coronation Dr, Auchenflower, QLD 4066
Ethics committee country [9] 4315 0
Australia
Date submitted for ethics approval [9] 4315 0
Approval date [9] 4315 0
14/03/2007
Ethics approval number [9] 4315 0
2007/01

Summary
Brief summary
The purpose of the study is to evaluate the safety of rivaroxaban in subjects with recent acute coronary syndrome and to assess the ability of rivaroxaban to reduce the rate of clinical events in those patients.
Trial website
Trial related presentations / publications
Public notes
FPFV occurred on 17 Nov 2006 in USA at a site where ethical approval was received on 9 Nov 2006. First ethical approval in Australia was on 10 Jan 2007 and first Australian patient visit was 21 Feb 2007

Contacts
Principal investigator
Name 27721 0
Address 27721 0
Country 27721 0
Phone 27721 0
Fax 27721 0
Email 27721 0
Contact person for public queries
Name 11096 0
Dr Phil Aylward
Address 11096 0
Flinders Medical Centre
1 Flinders Drive
Bedford SA 5042
Country 11096 0
Australia
Phone 11096 0
08 82042001
Fax 11096 0
Email 11096 0
phil.alyward@fmc.sa.gov.au
Contact person for scientific queries
Name 2024 0
Dr Phil Aylward
Address 2024 0
1 Flinders Medical Centre
Flinders Drive
Bedford SA 5042
Country 2024 0
Australia
Phone 2024 0
08 82042001
Fax 2024 0
Email 2024 0
phil.alyward@fmc.sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Mega JL, Braunwald E, Mohanavelu S, Burton P, Poul... [More Details]

Documents added automatically
No additional documents have been identified.