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Treat Stroke to Target (TST)

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ClinicalTrials.gov Identifier: NCT01252875
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : August 6, 2019
Sponsor:
Collaborators:
Pfizer
AstraZeneca
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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 for eight and a half years maximum.


Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack Atherosclerotic Stenosis Procedure: Target : 100 mg/dL (+/-10 mg/dL) Procedure: 70 mg/dL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2873 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : March 15, 2010
Actual Primary Completion Date : May 26, 2019
Actual Study Completion Date : May 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 eight and a half years maximum, 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




Primary Outcome Measures :
  1. recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death. [ Time Frame: each 6 months ]
    recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.


Secondary Outcome Measures :
  1. Recurrent nonfatal ischemic stroke [ Time Frame: each 6 months ]
    Recurrent nonfatal ischemic stroke

  2. Nonfatal myocardial infarction [ Time Frame: each 6 months ]
    Nonfatal myocardial infarction

  3. Recurrent ischemic stroke, fatal or non [ Time Frame: each 6 months ]
    Recurrent ischemic stroke, fatal or non

  4. Recurrent ischemic stroke or TIA [ Time Frame: each 6 months ]
    Recurrent ischemic stroke or TIA

  5. Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma) [ Time Frame: each three weeks until target is not achieved then each 6 months ]
    Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)

  6. All stroke (ischemic or hemorrhagic) [ Time Frame: each three weeks until target is not achieved then each 6 months ]
    All stroke (ischemic or hemorrhagic)

  7. Any major coronary events (including fatal and nonfatal myocardial infarction) [ Time Frame: each 6 months ]
    Any major coronary events (including fatal and nonfatal myocardial infarction)

  8. Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure) [ Time Frame: each 6 months ]
    Any coronary heart disease end-point (myocardial infarction, hospitalization for acute corornary symptoms, coronary revascularization procedure)

  9. Any revascularisation procedure (coronary, carotid, or peripheral artery)) [ Time Frame: each 6 months ]
    Any revascularisation procedure (coronary, carotid, or peripheral artery))

  10. Carotid artery revascularization procedure (urgent following new symptoms or elective) [ Time Frame: each 6 months ]
    Carotid artery revascularization procedure (urgent following new symptoms or elective)

  11. Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…) [ Time Frame: each 6 months ]
    Vascular death (ischemic stroke or undetermined stroke, fatal myocardial infarction, other vascular deaths, sudden death, death of undetermined cause, i.e., without other cause documented such as cancer, infection, accident, suicide, etc…)

  12. All causes deaths [ Time Frame: each 6 months ]
    All causes deaths

  13. Primary endpoint plus intracranial hemorrhage [ Time Frame: each 6 months ]
    Primary endpoint plus intracranial hemorrhage

  14. New onset diabetes [ Time Frame: each 6 months ]
    New onset diabetes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252875


Locations
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France
BICHAT HOSPITAL Departement of Neurology
Paris, France, 75018
BICHAT HOSPITAL Department of neurology and stroke center
Paris, France, 75018
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pfizer
AstraZeneca
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Pierre Amarenco, MD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01252875    
Other Study ID Numbers: P081244
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Assistance Publique - Hôpitaux de Paris:
LDL-C
Cholesterol
Stroke
Transient ischemic attack
Statin
Lipid lowering therapy
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents