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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
ARCH
Aortic Arch Related Cerebral Hazard



Principal Investigator
Geoffrey A. Donnan

PI Address
NSRI, Level 1, Neurosciences Building, Austin Hospital, 300 Waterdale Road, Heidelberg Heights, Victoria 3081, Australia
Email: gdonnan@unimelb.edu.au

Contact Address
European Coordinator:
Pierre Amarenco, Dep of Neurology and Stroke Centre, Bichat Hospital, 46 rue Henri Huchard, 75018, Paris, France, pierre.amarenco@bch.aphp.fr

Contact Email
gdonnan@unimelb.edu.au

Sponsor



Study Size Actual:368
Study Size Planned:925
Centers Actual:10
Centers Planned:15
Max Time from onset:6 Months
Follow-up Duration:2 Years
ISRCTN#NCT00235248
Status:
As of June 2005, 135 parients had been randoized. Trial is ongoing, and is currently recruiting both subjects and centers.

Purpose:
To compare the efficacy of anticoagulant therapy (warfarin) with that of anti-platelet therapy (aspirin in combination with clopidogrel) in preventing stroke in high-risk patients with aortic arch atheromas.

Interventions:
Aspirin (stroke prevention)
Antiplatelet agent; inhibits thromboxane A2
Clopidogrel
Antiplatelet agent
Warfarin
Anticoagulant (Vitamin K antagonist)

Location(s):
Australia, Europe

Year Started: 2002

Design:
Open-label, multicenter, randomized, controlled trial.

Inclusion Criteria
Patients with an ischemic stroke within 6 months, and an aortic arch atheroma that is either mobile or >= 4mm thick will be eligible for this trial.

Patient Involvement:
Patients will be randomized to receive either warfarin titrated to yield an international normalized ratio (INR) of 2.0-3.0 or 75-325 mg of aspirin plus 75 mg clopidogrel per day. Patients will be followed by 4 monthly reviews from randomization to the end of the study.

Primary Outcome:
Recurrent stroke, acute myocardial infarction, peripheral embolism, vascular death.

Source of Information:
Presented at the 28th International Stroke Conference (February 2003). Presented at 14th European Stroke Conference (May 2005). Correspondence with trial coordinator. Presented at International Stroke Conference (February 2008).

Web Links and Publications:
Aortic arch atheroma.
Int J Stroke 2006 May;1(2):74-80

Aortic Arch Related Cerebral Hazard (ARCH).
Ongoing Clinical Trials Session, 28th International Stroke Conference, 2003 [PDF Format]

ARCH
ClinicalTrials.gov

Myocardial Ischemia Research

This information last updated on: 1/23/2009

Reviewed on: 07/16/2009.

UID: 476

   

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