Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161070
Status:
COMPLETED
Last Update Posted:
2007-03-22
First Post:
2005-09-08
Brief Title:
ESPRIT EuropeanAustralasian Stroke Prevention in Reversible Ischaemia Trial
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
ESPRIT EuropeanAustralasian Stroke Prevention in Reversible Ischaemia Trial
Status:
COMPLETED
Status Verified Date:
2007-03
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:
None
Brief Summary:
The objective of ESPRIT was to compare the efficacy and safety of mild anticoagulation or a combination treatment of aspirin and dipyridamole with the efficacy and safety of treatment with aspirin alone after cerebral ischemia of arterial origin
Detailed Description:
Low-dose aspirin ASA at least 30 mgday prevents only 13 of subsequent vascular events after minor cerebral ischemia of arterial origin Anticoagulation AC has been proven highly effective in preventing vascular events after myocardial infarction and after cerebral ischemia in patients with atrial fibrillation A previous study on the effects of AC after cerebral ischemia of arterial origin SPIRIT showed that high intensity AC INR 30 to 45 is not safe but that mild AC INR 20 to 30 was The 2nd European Stroke Prevention Trial ESPS-2 reported a 22 relative risk reduction of the combination of ASA and dipyridamole DIP above that of ASA only its results however are subject to debate
Study design ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack TIA or a non-disabling ischemic stroke to either
A oral AC INR 20 to 30
B the combination of DIP 400 mg daily plus ASA 30-325 mgday or
C ASA only same dose
The mean follow-up was three years Primary outcome was the composite of vascular death stroke myocardial infarction or major bleeding Outcome assessment is blind
Study design ESPRIT was an open randomised controlled trial allocating patients who experienced a transient ischemic attack TIA or a non-disabling ischemic stroke to either
A oral AC INR 20 to 30
B the combination of DIP 400 mg daily plus ASA 30-325 mgday or
C ASA only same dose
The mean follow-up was three years Primary outcome was the composite of vascular death stroke myocardial infarction or major bleeding Outcome assessment is blind
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Eur Com QLK6-CT-2002-02332 | None | None | None |
| Heart Found 97026 | None | None | None |