Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235248
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2005-10-06
Brief Title:
Aortic Arch Related Cerebral Hazard Trial ARCH
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARCH
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 mgd plus aspirin 75 mgd 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
Hypothesis
The association of clopidogrel 75 mgd plus aspirin 75 mgd 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 eg renal infarct in the preceding 6 months and plaque 4 mm in the thoracic aorta above the origin of the embolized artery
4 mm in the aortic arch or patients with a peripheral event eg renal infarct in the preceding 6 months and plaque 4 mm in the thoracic aorta above the origin of the embolized artery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None