Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000214437
Ethics application status
Approved
Date submitted
27/03/2007
Date registered
19/04/2007
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study comparing the efficacy and safety of once-daily oral rivaroxaban with warfarin for the prevention of stroke and embolism in patients with atrial fibrillation.
Scientific title
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation
Secondary ID [1] 357 0
ClinicalTrials.org: NCT00403767
Universal Trial Number (UTN)
Trial acronym
ROCKET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation. 1741 0
Stroke 1742 0
Condition category
Condition code
Stroke 1833 1833 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is comparing the efficacy and safety of rivaroxaban with warfarin for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation. Those subjects assigned to rivaroxaban will receive rivaroxaban 20 mg orally once daily, plus warfarin placebo titrated to a sham International Normalised Ratio. Subjects with moderate renal impairment at screening (defined as calculated creatinine clearance between 30 and 49 ml/min inclusive) will receive a dose adaptation to rivaroxaban 15 mg once daily.
The duration of the treatment period for a given subject will depend on the time required to accrue the required number of adjudicated primary efficacy endpoint events. As a result, the time on study drug will vary from subject to subject, however the expected maximum duration of the study is 32 months, but may extend to 4 years.
Intervention code [1] 1669 0
Prevention
Comparator / control treatment
Those subjects assigned to warfarin will receive warfarin orally once daily titrated to a target INR of 2.5, plus rivaroxaban placebo.
Control group
Active

Outcomes
Primary outcome [1] 2565 0
Primary efficacy outcome is the composite of stroke and non-central nervous system systemic embolism.
Timepoint [1] 2565 0
Measured at the first occurrence from time of randomisation, then every 4 weeks to the end of follow-up period. That is an expected maximum of 32 months, but may extend to 4 years.
Secondary outcome [1] 4421 0
Individual components of the composite primary outcome; vascular death; myocardial infarctiion; disabling stroke; and all-cause mortality.
Timepoint [1] 4421 0
Measured at the first occurrence from time of randomisation, then every 4 weeks to the end of follow-up period. That is an expected maximum of 32 months, but may extend to 4 years.

Eligibility
Key inclusion criteria
Subjects must have documented atrial fibrillation on 2 separate occasions within 6 months before screening.History of prior stroke, transient ischemic attack or non-neurologic systemic embolism believed to be cardiac in origin, OR at least two of the following risk factors: heart failure, hypertension, age 75 years or greater, diabetes mellitus.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Significant mitral stenosis.Transient atrial fibrillation caused by a reversible disorder.Active internal bleeding.Severe disabling stroke.History of intracranial bleeding.Haemorrhagic disorders.

Study design
Purpose of the study
Prevention
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
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/12/2006
Actual
14/12/2006
Date of last participant enrolment
Anticipated
Actual
5/06/2009
Date of last data collection
Anticipated
Actual
3/09/2010
Sample size
Target
14269
Accrual to date
Final
14268
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 496 0
United States of America
State/province [1] 496 0

Funding & Sponsors
Funding source category [1] 1982 0
Commercial sector/Industry
Name [1] 1982 0
Bayer Australia Limited
Country [1] 1982 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] 1795 0
Commercial sector/Industry
Name [1] 1795 0
Johnson & Johnson Pharmaceutical Research & Development L.L.C.
Address [1] 1795 0
One Johnson & Johnson Plaza
New Brunswick, New Jersey, 08933
Country [1] 1795 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3680 0
Rivercity Private Hospital-Redcliffe-Caboolture Health Service District Ethics Committee
Ethics committee address [1] 3680 0
Ethics committee country [1] 3680 0
Australia
Date submitted for ethics approval [1] 3680 0
Approval date [1] 3680 0
06/12/2006
Ethics approval number [1] 3680 0
06/Dec/06
Ethics committee name [2] 3681 0
Peninsula Clinical Research Centre-Redcliffe-Caboolture Health Service District Ethics Committee
Ethics committee address [2] 3681 0
Ethics committee country [2] 3681 0
Australia
Date submitted for ethics approval [2] 3681 0
Approval date [2] 3681 0
14/02/2007
Ethics approval number [2] 3681 0
06/Dec/06
Ethics committee name [3] 3682 0
Caboolture Clinical Research Centre-Redcliffe-Caboolture Health Service District Ethics Committee
Ethics committee address [3] 3682 0
Ethics committee country [3] 3682 0
Australia
Date submitted for ethics approval [3] 3682 0
Approval date [3] 3682 0
14/02/2007
Ethics approval number [3] 3682 0
06/Dec/06

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27772 0
Dr Head of Development, CV and UROL
Address 27772 0
Johnson & Johnson Pharmaceutical Research & Development LLC
One Johnson & Johnson Plaza
New Brunswick, New Jersey 08933
Country 27772 0
United States of America
Phone 27772 0
+1 732 524 0400
Fax 27772 0
Email 27772 0
Not available
Contact person for public queries
Name 10858 0
Judith Ruijter
Address 10858 0
PAREXEL International
PO Box 351
North Ryde BC NSW 1670
Country 10858 0
Australia
Phone 10858 0
+61 2 88700533
Fax 10858 0
+61 2 88700503
Email 10858 0
Judith.Ruijter@Parexel.com
Contact person for scientific queries
Name 1786 0
Dr. Ahmad Hidayat
Address 1786 0
APEX International Clinical Research - Indonesia Office
Ariobimo Sentral 3th Floor Suite 303
Jl. HR. Rasuna Said Kav.X-2 No.5
Jakarta 12950
Country 1786 0
Indonesia
Phone 1786 0
+21 2525740 ext. 371
Fax 1786 0
+62 21 2525883
Email 1786 0
ahmad.hidayat@apex-cro.com

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.