Treat Stroke to Target (TST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborators:
Pfizer
AstraZeneca
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01252875
First received: December 2, 2010
Last updated: December 9, 2013
Last verified: December 2013
  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 for eight and a half years maximum.


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 2018
Estimated Primary Completion Date: September 2018 (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 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

  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
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: December 9, 2013
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:
Stroke
Cerebral Infarction
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014