Aortic Arch Related Cerebral Hazard Trial (ARCH) - Full Text View

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris National Health and Medical Research Council, Australia Sanofi-Aventis Bristol-Myers Squibb
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00235248

Purpose

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.

Condition	Intervention	Phase
Brain Infarction Transient Ischemic Attack Embolism	Drug: Clopidogrel + aspirin	Phase III

MedlinePlus related topics: Heart Attack Transient Ischemic Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

New vascular events assessed every 4 months including stroke, myocardial infarction (MI), peripheral events, and vascular death

Secondary Outcome Measures:

Recurrent brain infarction
brain infarction and transient ischemic attack (TIA)
new vascular events and revascularization procedure
vascular death
death from all causes
combination of primary end-point and TIA
revascularization procedures
urgent rehospitalization for ischemic

Estimated Enrollment:	650
Study Start Date:	February 2002
Estimated Study Completion Date:	October 2008

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235248

Contacts

Contact: Pierre Amarenco, Pr, MD, PhD

+33(0)-140258726

pierre.amarenco@bch.aphp.fr

Locations

Australia
National Stroke Research Institute-Austin Health	Recruiting
Heidelberg Heights, Australia, Vic 3081
Contact: Geoffrey A. Donnan, Pr, MD, PhD 613-9496-2699 gdonnan@unimelb.edu.au
Contact: Anna Marcon amarcon@nsri.org.au
France
Bichat Hospital Head of Neurology Department	Recruiting
Paris, France, 75018
Contact: Pierre Amarenco, Pr, MD, PhD +33(0)-1 40258726 pierre.amarenco@bch.aphp.fr

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

National Health and Medical Research Council, Australia

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Principal Investigator:

Pierre Amarenco, Pr, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

Study ID Numbers:	P991205, AOM97211
Study First Received:	October 6, 2005
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00235248
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

TIA/Brain infarct
and plaque>4mm in the aortic arch
Or peripheral embolism
and plaque>4 mm in the thoracic aorta

Study placed in the following topic categories:

Ischemic Attack, Transient
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Ischemia
Brain Diseases
Cerebrovascular Disorders
Thrombosis

Embolism and Thrombosis
Necrosis
Aspirin
Embolism
Clopidogrel
Brain Ischemia
Brain Infarction
Infarction

Additional relevant MeSH terms:

Pathologic Processes
Therapeutic Uses
Hematologic Agents
Nervous System Diseases

Platelet Aggregation Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009