Pre-stroke Cognitive Status and Thrombolytic Therapy

NCT01713491 | Completed DMC

• 2 other identifiers: 2010_04912079
• Study Type: observational
• Target: 205
• Locations: 2 countries
• Sites: 9

Brief Summary

At the acute stage of cerebral ischaemia, the only effective drug that increases the proportion of patients who survive without dependency is thrombolytic therapy by intravenous (i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice with similar results than in trials, in various places of the world including Europe and Japan. Stroke and dementia are closely related. About one patient in ten has dementia before a first-ever stroke, and more than one in three has dementia after a recurrent stroke. Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing cognitive impairment without dementia is associated with a higher rate of institutionalisation within 3 years. In many patients cognitive impairment is due to the summation of the effects of vascular and Alzheimer lesions of the brain. More and more patients nowadays who are eligible for rt-PA are already known as demented at admission. A retrospective study conducted in a cohort of patients with dementia who had an ischaemic stroke and were treated by rtPA suggested that there is no increased risk of cerebral bleeding and death as compared with non demented patients. However, pre-existing cognitive impairment is possibly associated with (i) an increased risk of bleeding in patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect of rt-PA on the brain tissue. Japanese patients differ from European patients by a higher risk of spontaneous intracranial haemorrhage, and a higher proportion of patients with small-vessel diseases. The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive impairment or dementia. The secondary objectives are to determine whether (i) they have an increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients who have a poor outcome is lower than expected from the placebo group of randomised trials for patients with a similar range of baseline severity, and (iii) the influence of the cognitive state on outcome differs between Japanese and European patients.

Conditions

Brain Ischemia; Adverse Effect of Thrombolytic Drugs; Impaired Cognition; Dementia

Keywords

brain ischemia; thrombolytic therapy; Impaired cognition; dementia

Outcome Measures

Primary Outcomes (1)

• Modified Rankin Scale score 0 or 1

  Month-3

Secondary Outcomes (4)

• Symptomatic intracerebral haemorrhage defined according to the ECASS2 definition

  7 days

• Death

  Day 7

• Modified Rankin Scale 0-2

  Month-3

• Death

  Month-3

Study Arms (3)

Cognitively normal

Patients with IQCODE score of 52 or less

Cognitively impaired - no dementia

IQCODE score 53 - 63

Demented

IQCODE score 64 or more

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated by iv tPA for acute cerebral ischaemia in routine practice

You may qualify if:

• All patients treated by iv tPA for cerebral ischaemia in routine practice in participating centres

You may not qualify if:

• index ischaemic stroke sparing MCA territory;
• thrombolytic therapy administered intra-arterially or combined with thrombectomy
• pre-stroke mRS of 2 or more
• impossibility to perform an IQCODE for any reason (no reliable informant available within 48 hours, not fluent in French or in Japanese or in a language spoken by the investigator), except when the patient had been diagnosed as demented by a specialist used to diagnose dementia (e.g. neurologist, psychiatrist, geriatrician) before stroke, or has a MMSE score of 30 at discharge.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (9)

Lille University Hospital

Lille, 59000, France

Location

Fukuoka Redcross Hospital

Fukuoka, Japan

Location

Fukuoka-Higashi Medical center

Fukuoka, Japan

Location

Kyushu Medical Center

Fukuoka, Japan

Location

Kyushu University

Fukuoka, Japan

Location

Kyushu Rosai Hospital

Kitakyushu, Japan

Location

Steel Memorial Yawata Hospital

Kitakyushu, Japan

Location

Kawasaki Medical University

Kurashiki, Japan

Location

St. Mary's Hospital

Kurume, Japan

Location

MeSH Terms

Conditions

Brain Ischemia; Cognition Disorders; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kei Murao, MD

  Lille University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2015
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8); FR (1)