Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms

Phase 3

• Conditions: Unruptured Intracranial Aneurysms
• Interventions: Drug: Acetylsalicylic acid; Other: intensive blood pressure control

• Registration Number: NCT03063541
• Lead Sponsor: Universitätsmedizin Mannheim

Brief Summary

Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below 120 mmHg), and a blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to standard blood pressure management, no blood pressure measuring device)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Study Start: 2017-09-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-23
• Last Update Posted: 2019-01-25
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 776

Inclusion Criteria

• Patients 18 years or older with an intradural, saccular unruptured aneurysm (UIA) in whom it is decided not to intervene with preventive endovascular or neurosurgical repair of the aneurysm and who are monitored on a regular base for aneurysm growth
• Last aneurysm imaging with either CTA/MRA/DSA within the last 3 months

Exclusion Criteria

• All non-saccular UIAs or aneurysms related to arteriovenous malformations
• Frequent ASA use and/or indication for a vitamin K antagonist, or direct oral anticoagulant (DOAC) treatment at baseline
• Contra-indication for ASA
• History of hypersensitivity to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
• Chronic kidney disease stage IV and V (GFR < 30 mL/min/1.73 m2)
• Pregnancy and lactation
• Participation in another clinical trial or observation period of competing trials, respectively
• Life-expectancy <3 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetylsalicylic acid, BP-target 120	intensive blood pressure control	100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
Acetylsalicylic acid, BP-target 120	Acetylsalicylic acid	100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg

Primary Outcome Measures

Name	Time	Method
aneurysm rupture or growth	36 months	aneurysm rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH) or growth (increase in any aneurysm diameter by ≥1mm) on serial imaging (either two MR or CT angiographies)

Secondary Outcome Measures

Name	Time	Method
therapy of aneurysm	36 months	clipping/coiling during the study period
new aneurysm	36 months	development of de novo aneurysm on serial imaging
major bleeding	36 months	major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates
Incidence of Treatment-Emergent Adverse and Serious Adverse Events	36 months	all adverse and serious adverse events related to the experimental intervention
aneurysm volume	36 months	difference of aneurysm volume (in computerized measurements defined as increase of aneurysm volume in computerized measurements by \>10% and \>3mm3 or aneurysm shape (e.g. development of daughter sac)
death	36 months	death from all other causes
stroke	36 months	any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging
myocard infarction	36 months	myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography
vascular death	36 months	vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
achieved blood pressure	36 months	any data on blood pressure management used

Trial Locations

Locations (14)

UMCG; 🇳🇱 Groningen, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Department of Neurology and Neurosurgery, Goethe University; 🇩🇪 Frankfurt am Main, Hessen, Germany

Neurochirurgische Klinik; 🇩🇪 Düsseldorf, Germany

Neurolgische Klinik; 🇩🇪 Erlangen, Germany

Neurochirurgische Klinik und Poliklinik; 🇩🇪 München, Germany

Neurologische Universitätsklinik; 🇩🇪 Heidelberg, Germany

Department of Neurosurgery, University Hospital Mannheim; 🇩🇪 Mannheim, Germany

AMC Department of Neurology; 🇳🇱 Amsterdam, Netherlands

Neurochirurgisch Centrum CWZ; 🇳🇱 Nijmegen, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

UMC; 🇳🇱 Utrecht, Netherlands

Klinik für Neurochirurgie; 🇩🇪 Hamburg, Germany