Status:
COMPLETED
Treat Stroke to Target
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Pfizer
AstraZeneca
Conditions:
Ischemic Stroke
Transient Ischemic Attack
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and...
Detailed Description
The aim of this study is the evaluation of two usual care strategies after stroke or TIA : achieved target LDL-C of 100 mg/dL (+/-10 mg/dL) or less than 70 mg/dL. Investigators will use the statin and...
Eligibility Criteria
Inclusion
- • Recent (less than 3 months) ischemic stroke
- As soon as possible after the event, once the neurologic deficit is stabilized (investigator judgment)
- These ischemic strokes include TIA with ischemic lesion documented by CT or MRI
- • Or recent TIA (less than 15 days)
- without documentation of ischemic lesion on CT/MR imaging
- Must be limb weakness or aphasia lasting more than 10 min
- • And documented atherosclerotic stenosis
- In carotid artery (investigator judgment) (based on the results of Duplex echography, CTA, MRA or X ray- angiography)
- Or in the aortic arch (investigator judgment) (based on TEE or CTA)
- Or in other brain artery: vertebral, basilar or other intracranial artery (based on CTA, MRA, XRA)
- Or in coronary arteries (past history of acute coronary syndrome, coronary revascularization or positive coronary angiography)
- • And
- Statin treatment is indicated, following ANSM guidelines (French drug agency)
- age \>18 years
- rankin score ≤ 4
- patient or a legal representative signs consent
- Patient is affiliated to social security system
Exclusion
- • Ischemic stroke/TIA du to
- arterial dissection (investigator judgment)
- Cardiac source of embolism (e.g., mitral stenosis, endomyocardial fibrosis) without documented atherosclerotic stenosis : a patient with atrial fibrillation or a past history of recent myocardial infarction or calcified aortic stenosis can be randomized if he otherwise fulfils inclusion criteria
- • Symptomatic hemorrhagic stroke
- Presence of microbleeds on gradient echo imaging (T2\*) is not an exclusion criteria.
- Hemorrhagic transformation of an ischemic stroke is not an exclusion criteria
- Uncontrolled hypertension (investigator judgment)
- LDL-C \<100 mg/dL or patients for whom treatment intensification is impossible
- F/U impossible or bad observance anticipated.
- Co-morbid condition that may interfere with the F/U or with the evaluation of primary endpoint
- Participation to another clinical trial
Key Trial Info
Start Date :
March 15 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2019
Estimated Enrollment :
2873 Patients enrolled
Trial Details
Trial ID
NCT01252875
Start Date
March 15 2010
End Date
May 26 2019
Last Update
August 6 2019
Active Locations (2)
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1
BICHAT HOSPITAL Departement of Neurology
Paris, France, 75018
2
BICHAT HOSPITAL Department of neurology and stroke center
Paris, France, 75018