Brain InfarctionPhase 3ARCHNCT00235248
Aortic Arch Related Cerebral Hazard Trial (ARCH)
A Phase 3 study testing Warfarin and Clopidogrel-aspirin in people with Brain Infarction and Transient Ischemic Attack, run by Assistance Publique - Hôpitaux de Paris at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Infarction, Transient Ischemic Attack, Embolism
- What is being tested?
- Warfarin and Clopidogrel-aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2002to Jul 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Duration of symptoms and signs greater than 24 hours
- Neurological signs at the time of randomization with a Rankin Scale grade 3 or less
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
National Stroke Research Institute-Austin Health
Heidelberg Heights, Vic 3081
About this study
Official 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
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.
Read the detailed description
Patients with Transient Ischemic attack or brain infarction of unknown cause (no ipsilateral internal carotid artery origin stenosis greater than 70%, no ipsilateral severe intracranial stenosis of an artery supplying the infarcted area, no definite cardiac source of embolism) in the preceding 6 months and atherosclerotic plaques.
≥ 4 mm in the aortic arch, or patients with a peripheral event (e.g. renal infarct) in the preceding 6 months and plaque ≥ 4 mm in the thoracic aorta above the origin of the embolized artery.
- Conditions
- Brain Infarction, Transient Ischemic Attack, Embolism
- Being tested
- Warfarin, Clopidogrel-aspirin
- Keywords
- TIA/Brain infarct, and plaque>4mm in the aortic arch, Or peripheral embolism, and plaque>4 mm in the thoracic aorta
- Medical subject headings
- Brain Infarction, Ischemic Attack, Transient, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WarfarinDrug
Warfarin
Clopidogrel-aspirinDrug
Clopidogrel-aspirin
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel-aspirin | Experimental | Clopidogrel-aspirin Receives: Drug: Clopidogrel-aspirin |
| Warfarin | Active comparator | Warfarin Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 4 months
Secondary outcomes (8)
Recurrent brain infarction
Recurrent brain infarction
Measured: during the trial
brain infarction and transient ischemic attack (TIA)
brain infarction and transient ischemic attack (TIA)
Measured: during the studing
new vascular events and revascularization procedure
new vascular events and revascularization procedure
Measured: during the trial
vascular death
vascular death
Measured: during the trial
death from all causes
death from all causes
Measured: during the trial
combination of primary end-point and TIA
combination of primary end-point and TIA
Measured: during the trial
revascularization procedures
revascularization procedures
Measured: during the trial
urgent rehospitalization for ischemic
urgent rehospitalization for ischemic
Measured: during the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2005 (estimated)
- Study startFeb 2002
- Primary completionDec 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sanofi, Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Pierre Amarenco, Pr, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00235248
- Sponsor's protocol ID
- P991205
- Acronym
- ARCH
- Status last verified
- Jul 2012
- First submitted
- 6 Oct 2005
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amarenco P, Davis S, Jones EF, Cohen AA, Heiss WD, Kaste M, Laouenan C, Young D, Macleod M, Donnan GA; Aortic Arch Related Cerebral Hazard Trial Investigators. Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques. Stroke. 2014 May;45(5):1248-57. doi: 10.1161/STROKEAHA.113.004251. Epub 2014 Apr 3.
PubMed 24699050
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00235248
- Acronym / sponsor ID
- ARCH / P991205
- Conditions
- Brain Infarction, Transient Ischemic Attack, Embolism
- Keywords
- TIA/Brain infarct, and plaque>4mm in the aortic arch, Or peripheral embolism, and plaque>4 mm in the thoracic aorta
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Sanofi, Bristol-Myers Squibb
- Study start
- Feb 2002
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 10 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with Transient Ischemic attack or brain infarction of unknown cause (no ipsilateral internal carotid artery origin stenosis greater than 70%, no ipsilateral severe intracranial stenosis of an artery supplying the infarcted area, no definite cardiac source of embolism) in the preceding 6 months and atherosclerotic plaques.
≥ 4 mm in the aortic arch, or patients with a peripheral event (e.g. renal infarct) in the preceding 6 months and plaque ≥ 4 mm in the thoracic aorta above the origin of the embolized artery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel-aspirin | Experimental | Drug: Clopidogrel-aspirinClopidogrel-aspirin |
| Warfarin | Active comparator | Drug: WarfarinWarfarin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- One of the 3 following ischemic events in the preceding 6 months:
- 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
Key exclusion criteria (15 listed)
- Other causes of embolism:
- Other exclusion criteria:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WarfarinWarfarin | Drug | Warfarin |
| Clopidogrel-aspirinClopidogrel-aspirin | Drug | Clopidogrel-aspirin |
Primary outcome
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
Time frame: every 4 months
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death
8 secondary outcomes
Recurrent brain infarction
Time frame: during the trial
brain infarction and transient ischemic attack (TIA)
Time frame: during the studing
new vascular events and revascularization procedure
Time frame: during the trial
vascular death
Time frame: during the trial
death from all causes
Time frame: during the trial
combination of primary end-point and TIA
Time frame: during the trial
revascularization procedures
Time frame: during the trial
urgent rehospitalization for ischemic
Time frame: during the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2012.
- Derived from this study: PubMed 24699050Amarenco P, Davis S, Jones EF, Cohen AA, Heiss WD, Kaste M, Laouenan C, Young D, Macleod M, Donnan GA; Aortic Arch Related Cerebral Hazard Trial Investigators. Clopidogrel plus aspirin versus warfarin in patients with stroke and aortic arch plaques. Stroke. 2014 May;45(5):1248-57. doi: 10.1161/STROKEAHA.113.004251. Epub 2014 Apr 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Amarenco, Pr, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Warfarin and Clopidogrel-aspirin in people with Brain Infarction and Transient Ischemic Attack, run by Assistance Publique - Hôpitaux de Paris at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death (time frame: every 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00235248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.