Antiplatelet Therapy for Silent Brain Infarction

NCT03318744 | Unknown DMC

• 1 other identifier: FirstPHShenyang
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief Summary

Silent brain infarction (SBI) or incidental infarct is common. Recent studies revealed individuals with SBI have an increased risk of future stroke. Even though the 2014 AHA/ASA recommendation for ischemic stroke and transient ischemic attack considered SBI as an entry point for secondary prevention, convincing evidence with regard to the preventive efficacy of antiplatelet therapy against incident stroke in SBI is scant. Investigators examine if antiplatelet therapy can effectively decrease the incidence of future stroke in SBI individuals.

Conditions

Brain Infarction

Keywords

Silent Brain Infarction; Antithrombotics; Antiplatelet; Aspirin; Asymptomatic

Outcome Measures

Primary Outcomes (1)

• composite outcome with any incident stroke, myocardial infarction and all-cause death

  24 months

Secondary Outcomes (1)

• ischemic stroke, intracranial cerebral hemorrhage, any bleeding, independence (mRS≥2)

  24 months

Study Arms (2)

aspirin 100mg

EXPERIMENTAL

Participants will be given aspirin 100mg once per day.

Drug: Aspirin

placebo

PLACEBO COMPARATOR

Participants will be given placebo oral tablets once per day.

Drug: Placebo Oral Tablet

Interventions

Aspirin DRUG

Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.

Also known as: Bayaspirin

aspirin 100mg

Placebo Oral Tablet DRUG

Placebo resembling aspirin tablet will be be given to participants in control arm.

placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• cerebral infarction(s) identified by CT/MRI (≥ 3mm in diameter)
• absence of signs or symptoms of neurological dysfunction ascribed to the lesion(s)
• absence of PMH of neurological dysfunctions due to CNS lesion(s)

You may not qualify if:

• Age under 45 years or above 80 years
• PMH of ICH within 180 days
• PMH of lobar hemorrhage of anytime
• Neuroimaging evidence suggesting cerebral microbleeds
• High risk of bleeding (e.g. recurrent gastrointestinal or genitourinary bleeding, active peptic ulcer disease)
• Anticipated requirement for long-term use (more than 28 days) of anticoagulants (e.g. recurrent deep vein thrombosis)
• Prior long-term use of anticoagulants (more than 28 days) or antiplatelet agents (more than 28 days)
• Prior retinal stroke/TIA (diagnosed either clinically or by imaging)
• Intolerance or contraindications to aspirin (including thrombocytopenia, prolonged INR)
• Prior ipsilateral carotid endarterectomy/stent
• Stenosis of culprit artery ≥ 70% (detected by ultrasound, MRA, CTA or DSA)
• Atrial fibrillation, or acute myocardial infarction, or acute congestive heart failure
• Impaired renal function: glomerular filtration rate\<60
• Mini Mental Status Examination score\<24 (adjusted for age and education)
• Medical contraindication to MRI

Sponsors & Collaborators

• First People's Hospital of Shenyang: lead

Study Sites (1)

Shenyang Brain Hsopital

Shenyang, Liaoning, 110041, China

Location

Related Publications (7)

• Weber R, Weimar C, Wanke I, Moller-Hartmann C, Gizewski ER, Blatchford J, Hermansson K, Demchuk AM, Forsting M, Sacco RL, Saver JL, Warach S, Diener HC, Diehl A; PRoFESS Imaging Substudy Group. Risk of recurrent stroke in patients with silent brain infarction in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) imaging substudy. Stroke. 2012 Feb;43(2):350-5. doi: 10.1161/STROKEAHA.111.631739. Epub 2012 Jan 19.

  PMID: 22267825 BACKGROUND

• Chou CC, Lien LM, Chen WH, Wu MS, Lin SM, Chiu HC, Chiou HY, Bai CH. Adults with late stage 3 chronic kidney disease are at high risk for prevalent silent brain infarction: a population-based study. Stroke. 2011 Aug;42(8):2120-5. doi: 10.1161/STROKEAHA.110.597930. Epub 2011 Jun 23.

  PMID: 21700935 BACKGROUND

• Nakagawa T, Sekizawa K, Nakajoh K, Tanji H, Arai H, Sasaki H. Silent cerebral infarction: a potential risk for pneumonia in the elderly. J Intern Med. 2000 Feb;247(2):255-9. doi: 10.1046/j.1365-2796.2000.00599.x.

  PMID: 10692089 BACKGROUND

• Wang Y, Zhao X, Liu L, Soo YO, Pu Y, Pan Y, Wang Y, Zou X, Leung TW, Cai Y, Bai Q, Wu Y, Wang C, Pan X, Luo B, Wong KS; CICAS Study Group. Prevalence and outcomes of symptomatic intracranial large artery stenoses and occlusions in China: the Chinese Intracranial Atherosclerosis (CICAS) Study. Stroke. 2014 Mar;45(3):663-9. doi: 10.1161/STROKEAHA.113.003508. Epub 2014 Jan 30.

  PMID: 24481975 BACKGROUND

• Caplan LR, Hennerici M. Impaired clearance of emboli (washout) is an important link between hypoperfusion, embolism, and ischemic stroke. Arch Neurol. 1998 Nov;55(11):1475-82. doi: 10.1001/archneur.55.11.1475.

  PMID: 9823834 BACKGROUND

• Gupta A, Giambrone AE, Gialdini G, Finn C, Delgado D, Gutierrez J, Wright C, Beiser AS, Seshadri S, Pandya A, Kamel H. Silent Brain Infarction and Risk of Future Stroke: A Systematic Review and Meta-Analysis. Stroke. 2016 Mar;47(3):719-25. doi: 10.1161/STROKEAHA.115.011889.

  PMID: 26888534 BACKGROUND

• Smith EE, Saposnik G, Biessels GJ, Doubal FN, Fornage M, Gorelick PB, Greenberg SM, Higashida RT, Kasner SE, Seshadri S; American Heart Association Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Functional Genomics and Translational Biology; and Council on Hypertension. Prevention of Stroke in Patients With Silent Cerebrovascular Disease: A Scientific Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2017 Feb;48(2):e44-e71. doi: 10.1161/STR.0000000000000116. Epub 2016 Dec 15.

  PMID: 27980126 BACKGROUND

MeSH Terms

Conditions

Brain Infarction

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yi Sui, MD PhD

  First People's Hospital of Shenyang

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Sui, MD PhD

CONTACT

+86 24 31956417; jakeyisui@icloud.com

Ying Xiao, MMed

CONTACT

+86 24 31956417; 438505109@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 24, 2017
• Study Start: January 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 25, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)