Treat Stroke to Target (TST)
This study is currently recruiting participants.
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborators:
Pfizer
AstraZeneca
Merck
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01252875
First received: December 2, 2010
Last updated: October 30, 2012
Last verified: October 2012
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Purpose
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 titrate the dosage to achieve the target assigned by randomization in monotherapy or in combination with ezetimibe or other drugs.
The primary end-point is the occurrence of recurrent non fatal stroke, non fatal MI, and vascular death in each group.
3760 patients will be recruited and followed during three years.
| Condition | Intervention |
|---|---|
|
Ischemic Stroke Transient Ischemic Attack Atherosclerotic Stenosis |
Procedure: Target : 100 mg/dL (+/-10 mg/dL) Procedure: 70 mg/dL |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | EVALUATION OF TWO SECONDARY CARE STRATEGIES AFTER STROKE OR TRANSIENT ISCHEMIC ATTACK (TIA): ACHEIVED TARGET LDL-C TO 100 mg/dL (+/- 10,mg/dL) OR LESS THAN 70 mg/dL. |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Recurrent of non fatal stroke, non fatal IM, and vascular death [ Time Frame: each three weeks until target is not achieved then each 6 months ] [ Designated as safety issue: No ]Recurrent of non fatal stroke, non fatal IM, and vascular death
Secondary Outcome Measures:
- Recurrent of fatal and non fatal stroke, stroke and TIA. [ Time Frame: each three weeks until target is not achieved then each 6 months ] [ Designated as safety issue: No ]Recurrent of fatal and non fatal stroke, stroke and TIA, major coronary event (MI, sudden death, coronary revascularization for an ACS), any coronary endpoints (MI, hospitalization for ACS, coronary revascularization), any revascularization procedures (coronary, carotid, peripheral), carotid revascularization (either surgical or endovascular), vascular death, total death
| Estimated Enrollment: | 3760 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | September 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
LDL-C to100 mg/dL (+/-10 mg/dL)
Target : 100 mg/dL (+/-10 mg/dL): Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of 100 mg/dL(+/-10 mg/dL). |
Procedure: Target : 100 mg/dL (+/-10 mg/dL)
Statin +/- other lipid lowering therapy during 3 years, Target : LDL-C =100 mg/dL (+/-10 mg/dL), recording recurrent non fatal stroke, non fatal MI, and vascular death and others endpoints such as new onset diabetes, hemorrhagic strokes.
Other Name: treat to target
|
|
LDL-C < 70 mg/dL
70 mg/dL: Patients recruited in this arm will receive statin +/-other lipid lowering therapy in order to reach a LDL-C concentration of less than 70 mg/dL.
|
Procedure: 70 mg/dL
Statin +/-lipid lowering therapy during 3 years, Target : LDL-C concentration of less than 70 mg/dL, recording recurrent of non fatal stroke, non fatal IM, and vascular death and others endpoints such as: new onset diabetes, hemorrhagic strokes.
Other Name: treat to target
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- • 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 AFSSAPS 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 Criteria:
- • 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252875
Contacts
| Contact: Pierre Amarenco, MD | +33 (0) 1 40 25 87 26 | pierre.amarenco@bch.aphp.fr |
Locations
| France | |
| BICHAT HOSPITAL Department of neurology and stroke center | Recruiting |
| Paris, France, 75018 | |
| Contact: Pierre Amarenco, MD +33 (0) 1 40 25 87 26 ext 87 24 pierre.amarenco@bch.aphp.fr | |
| BICHAT HOSPITAL Departement of Neurology | Recruiting |
| Paris, France, 75018 | |
| Contact: Pierre AMARENCO, Pr, MD, PhD +33(0)1 40 25 87 26 Pierre.amarenco@bch.aphp.fr | |
| Principal Investigator: Pierre AMARENCO, Pr, MD, PhD | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pfizer
AstraZeneca
Merck
Investigators
| Principal Investigator: | Pierre Amarenco, MD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01252875 History of Changes |
| Other Study ID Numbers: | P081244 |
| Study First Received: | December 2, 2010 |
| Last Updated: | October 30, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
LDL-C Cholesterol Stroke |
Transient ischemic attack Statin Lipid lowering therapy |
Additional relevant MeSH terms:
|
Ischemic Attack, Transient Ischemia Stroke Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction |
ClinicalTrials.gov processed this record on May 21, 2013