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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00235248




Registration number
NCT00235248
Ethics application status
Date submitted
6/10/2005
Date registered
10/10/2005
Date last updated
10/07/2012

Titles & IDs
Public title
Aortic Arch Related Cerebral Hazard Trial (ARCH)
Scientific title
Prevention of New Vascular Events in Patients With Brain Infarction or Peripheral Embolism and Thoracic Aortic Plaques = 4 mm in Thickness in the Aortic Arch or Descending Aortic Upstream to the Embolized Artery
Secondary ID [1] 0 0
P991205
Universal Trial Number (UTN)
Trial acronym
ARCH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Infarction 0 0
Transient Ischemic Attack 0 0
Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Warfarin
Treatment: Drugs - Clopidogrel-aspirin

Experimental: Clopidogrel-aspirin - Clopidogrel-aspirin

Active Comparator: Warfarin - Warfarin


Treatment: Drugs: Warfarin
Warfarin

Treatment: Drugs: Clopidogrel-aspirin
Clopidogrel-aspirin

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death - New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
Timepoint [1] 0 0
every 4 months
Secondary outcome [1] 0 0
Recurrent brain infarction - Recurrent brain infarction
Timepoint [1] 0 0
during the trial
Secondary outcome [2] 0 0
brain infarction and transient ischemic attack (TIA) - brain infarction and transient ischemic attack (TIA)
Timepoint [2] 0 0
during the studing
Secondary outcome [3] 0 0
new vascular events and revascularization procedure - new vascular events and revascularization procedure
Timepoint [3] 0 0
during the trial
Secondary outcome [4] 0 0
vascular death - vascular death
Timepoint [4] 0 0
during the trial
Secondary outcome [5] 0 0
death from all causes - death from all causes
Timepoint [5] 0 0
during the trial
Secondary outcome [6] 0 0
combination of primary end-point and TIA - combination of primary end-point and TIA
Timepoint [6] 0 0
during the trial
Secondary outcome [7] 0 0
revascularization procedures - revascularization procedures
Timepoint [7] 0 0
during the trial
Secondary outcome [8] 0 0
urgent rehospitalization for ischemic - urgent rehospitalization for ischemic
Timepoint [8] 0 0
during the trial

Eligibility
Key inclusion criteria
Patients of both sexes aged = 18 years with the following 4 inclusion criteria:

- One of the 3 following ischemic events in the preceding 6 months:

- Transient ischemic attack (TIA)

- Non-disabling brain infarcts:

- Inclusion within 6 months after onset

- Duration of symptoms and signs greater than 24 hours

- Neurological signs at the time of randomization with a Rankin Scale grade 3
or less

- With normal computed tomography (CT) scan or CT scan showing a brain infarct
(even hemorrhagic infarct)

- Peripheral embolism

- Atherosclerotic plaque in the thoracic aorta is defined as wall thickness = 4 mm where
the protruding material is the largest, measured at transesophageal echocardiography
with multiplane transducer or a plaque less than 4 mm but with mobile component.

- Informed consent signed

- Life expectancy > 3 years
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Other causes of embolism:

- Cardiac: endocarditis, atrial fibrillation, intra-cardiac thrombus, valvular
prosthesis, rheumatic valvulopathy, left ventricular aneurysm, or ejection
fraction less than 25%

- Atherosclerotic stenosis ipsilateral to the embolic territory: internal carotid
artery stenosis greater than 70%, or severe (judgment of the investigator)
intracranial stenosis, or scheduled carotid endarterectomy (in that case
inclusion is possible 30 days after the procedure)

- Uncommon causes: dissection, vasculitis, procoagulant state, or sickle cell
disease

- Other exclusion criteria:

- Intercurrent illness with life expectancy less than 36 months

- Pregnancy and non-menopausal women

- Unwillingness to participate

- Poor medication compliance expected

- Toxicomania

- Absolute indication for anticoagulant therapy (e.g. atrial fibrillation,
intracardiac thrombus, prosthetic valve)

- Scheduled for carotid endarterectomy (randomization is possible 30 days after
endarterectomy)

- CT scan with an intracranial lesion other than brain infarction (space occupying mass,
intracranial hemorrhage)

- Transesophageal echocardiography (TEE) with plaque = 4 mm in thickness distal to the
supposed embolized artery (judgement of the investigator).

- Contraindication to clopidogrel, aspirin, and oral anticoagulants

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
National Stroke Research Institute-Austin Health - Heidelberg Heights
Recruitment postcode(s) [1] 0 0
Vic 3081 - Heidelberg Heights
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Paris

Funding & Sponsors
Primary sponsor type
Other
Name
Assistance Publique - Hôpitaux de Paris
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Sanofi
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Bristol-Myers Squibb
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The ARCH is a controlled trial with a sequential design and with a prospective, randomized,
open-label, blinded-endpoint (PROBE) methodology. The objective is to compare the efficacy
and tolerance (net benefit) of two antithrombotic strategies in patients with
atherothrombosis of the aortic arch and a recent (less than 6 months) cerebral or peripheral
embolic event.

Hypothesis:

The association of clopidogrel 75 mg/d plus aspirin 75 mg/d is 25% more effective than an
oral anticoagulant (target International Normalized Ratio [INR] 2 to 3) in preventing brain
infarction, brain hemorrhage, myocardial infarction, peripheral embolism, and vascular death.
Trial website
https://clinicaltrials.gov/show/NCT00235248
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pierre Amarenco, Pr, MD, PhD
Address 0 0
Assistance Publique - Hôpitaux de Paris
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications