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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Timepoint [1] 0 0
every 4 months
Secondary outcome [1] 0 0
Recurrent brain infarction
Timepoint [1] 0 0
during the trial
Secondary outcome [2] 0 0
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
Timepoint [3] 0 0
during the trial
Secondary outcome [4] 0 0
vascular death
Timepoint [4] 0 0
during the trial
Secondary outcome [5] 0 0
death from all causes
Timepoint [5] 0 0
during the trial
Secondary outcome [6] 0 0
combination of primary end-point and TIA
Timepoint [6] 0 0
during the trial
Secondary outcome [7] 0 0
revascularization procedures
Timepoint [7] 0 0
during the trial
Secondary outcome [8] 0 0
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
Sex
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
1/02/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2012
Sample size
Target
Accrual to date
Final
350
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00235248