NCT01252875

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,873

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2019

Completed
Last Updated

August 6, 2019

Status Verified

June 1, 2019

Enrollment Period

9.2 years

First QC Date

December 2, 2010

Last Update Submit

August 2, 2019

Conditions

Ischemic StrokeTransient Ischemic AttackAtherosclerotic Stenosis

Keywords

LDL-CCholesterolStrokeTransient ischemic attackStatinLipid lowering therapy

Outcome Measures

Primary Outcomes (1)

  • recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.

    recurrent ischemic stroke or stroke of undetermined origin, myocardial infarction, urgent coronary or carotid revascularization following new symptoms requiring hospitalization, and vascular death.

    each 6 months

Secondary Outcomes (14)

  • Recurrent nonfatal ischemic stroke

    each 6 months

  • Nonfatal myocardial infarction

    each 6 months

  • Recurrent ischemic stroke, fatal or non

    each 6 months

  • Recurrent ischemic stroke or TIA

    each 6 months

  • Intracranial hemorrhage (intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma)

    each three weeks until target is not achieved then each 6 months

  • +9 more secondary outcomes

Study Arms (2)

LDL-C to100 mg/dL (+/-10 mg/dL)

OTHER

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)

LDL-C < 70 mg/dL

OTHER

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

Interventions

Target : 100 mg/dL (+/-10 mg/dL)PROCEDURE

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.

Also known as: treat to target
LDL-C to100 mg/dL (+/-10 mg/dL)
70 mg/dLPROCEDURE

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.

Also known as: treat to target
LDL-C < 70 mg/dL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • Ischemic stroke/TIA du to
  • arterial dissection (investigator judgment)
  • Symptomatic hemorrhagic stroke
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BICHAT HOSPITAL Departement of Neurology

Paris, 75018, France

Location

BICHAT HOSPITAL Department of neurology and stroke center

Paris, 75018, France

Location

Related Publications (8)

  • Amarenco P, Lavallee PC, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. More Than 50 Percent Reduction in LDL Cholesterol in Patients With Target LDL <70 mg/dL After a Stroke. Stroke. 2023 Aug;54(8):1993-2001. doi: 10.1161/STROKEAHA.123.042621. Epub 2023 Jun 28.

    PMID: 37376989DERIVED

  • Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Yield of Dual Therapy With Statin and Ezetimibe in the Treat Stroke to Target Trial. Stroke. 2022 Nov;53(11):3260-3267. doi: 10.1161/STROKEAHA.122.039728. Epub 2022 Sep 26.

    PMID: 36154103DERIVED

  • Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lavallee PC, Lee BC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators*. Intracranial Hemorrhage in the TST Trial. Stroke. 2022 Feb;53(2):457-462. doi: 10.1161/STROKEAHA.121.035846. Epub 2021 Dec 29.

    PMID: 34963300DERIVED

  • Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Lavallee PC, Mahagne MH, Meseguer E, Nighoghossian N, Steg PG, Vicaut E, Bruckert E; Treat Stroke to Target Investigators; Treat Stroke to Target investigators:. Impact of Lower Versus Higher LDL Cholesterol Targets on Cardiovascular Events After Ischemic Stroke in Patients With Diabetes. Diabetes. 2021 Aug;70(8):1807-1815. doi: 10.2337/db21-0302. Epub 2021 May 12.

    PMID: 33980690DERIVED

  • Amarenco P, Hobeanu C, Labreuche J, Charles H, Giroud M, Meseguer E, Lavallee PC, Gabriel Steg P, Vicaut E, Bruckert E, Touboul PJ. Carotid Atherosclerosis Evolution When Targeting a Low-Density Lipoprotein Cholesterol Concentration <70 mg/dL After an Ischemic Stroke of Atherosclerotic Origin. Circulation. 2020 Aug 25;142(8):748-757. doi: 10.1161/CIRCULATIONAHA.120.046774. Epub 2020 Jun 29.

    PMID: 32594766DERIVED

  • Amarenco P, Kim JS, Labreuche J, Charles H, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Gabriel Steg P, Vicaut E, Bruckert E; Treat Stroke to Target Investigators. Benefit of Targeting a LDL (Low-Density Lipoprotein) Cholesterol <70 mg/dL During 5 Years After Ischemic Stroke. Stroke. 2020 Apr;51(4):1231-1239. doi: 10.1161/STROKEAHA.119.028718. Epub 2020 Feb 20.

    PMID: 32078484DERIVED

  • Amarenco P, Kim JS, Labreuche J, Giroud M, Lee BC, Mahagne MH, Nighoghossian N, Simon T, Steg PG, Touboul PJ, Vicaut E, Yelles N, Bruckert E. Treat stroke to target trial design: First trial comparing two LDL targets in patients with atherothrombotic strokes. Eur Stroke J. 2019 Sep;4(3):271-280. doi: 10.1177/2396987319838100. Epub 2019 Mar 26.

    PMID: 31984235DERIVED

  • Amarenco P, Kim JS, Labreuche J, Charles H, Abtan J, Bejot Y, Cabrejo L, Cha JK, Ducrocq G, Giroud M, Guidoux C, Hobeanu C, Kim YJ, Lapergue B, Lavallee PC, Lee BC, Lee KB, Leys D, Mahagne MH, Meseguer E, Nighoghossian N, Pico F, Samson Y, Sibon I, Steg PG, Sung SM, Touboul PJ, Touze E, Varenne O, Vicaut E, Yelles N, Bruckert E; Treat Stroke to Target Investigators. A Comparison of Two LDL Cholesterol Targets after Ischemic Stroke. N Engl J Med. 2020 Jan 2;382(1):9. doi: 10.1056/NEJMoa1910355. Epub 2019 Nov 18.

    PMID: 31738483DERIVED

MeSH Terms

Conditions

Ischemic StrokeIschemic Attack, TransientStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Pierre Amarenco, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2010

First Posted

December 3, 2010

Study Start

March 15, 2010

Primary Completion

May 26, 2019

Study Completion

May 26, 2019

Last Updated

August 6, 2019

Record last verified: 2019-06

Locations

FR(2)