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

Unruptured Intracranial Aneurysms Clinical Trial

— PROTECT-U  

Official title:

Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03063541
• Other study ID #: PROTECT-U_V2.2_20_Feb_2017
• Secondary ID: 2017-000514-35
• Status: Recruiting
• Phase: Phase 3
• Start date: September 21, 2017
• Est. completion date: October 2022

Study information

• Verified date: January 2019
• Source: Universitätsmedizin Mannheim
• Contact: Nima Etminan, PD Dr. med.
• Phone: +49 621 383-2360
• Email: Nima.Etminan[@]umm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 776
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Intracranial Aneurysms

Intervention

Drug:
• Acetylsalicylic acid
100 mg daily as one tablet

Other:
• intensive blood pressure control
Patients are encouraged to seek any therapy to have a systolic blood pressure of 120 or below. They will be provided with a blood pressure measurement device and are advised to control blood pressure daily.

Locations

Country	Name	City	State
Germany	Klinik für Neurochirurgie	Aachen
Germany	Neurochirurgische Klinik	Berlin
Germany	Neurochirurgische Klinik	Düsseldorf
Germany	Neurolgische Klinik	Erlangen
Germany	Klinik für Neurochirurgie	Essen
Germany	Department of Neurology and Neurosurgery, Goethe University	Frankfurt am Main	Hessen
Germany	Klinik für Neurochirurgie	Göttingen
Germany	Klinik für Neurochirurgie	Hamburg
Germany	Neurologische Universitätsklinik	Heidelberg
Germany	Department of Neurosurgery, University Hospital Mannheim	Mannheim
Germany	Neurochirurgische Klinik und Poliklinik	München
Germany	Universitätsklinikum Münster	Münster
Netherlands	AMC Department of Neurology	Amsterdam
Netherlands	UMCG	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Neurochirurgisch Centrum CWZ	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Netherlands	UMC	Utrecht

Sponsors (5)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim	KKS Netzwerk, Schwiete Stiftung, Mannheim, Germany, UMC Utrecht, University of Hamburg

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (1)

Vergouwen MD, Rinkel GJ, Algra A, Fiehler J, Steinmetz H, Vajkoczy P, Rutten FH, Luntz S, Hänggi D, Etminan N. Prospective Randomized Open-label Trial to evaluate risk faCTor management in patients with Unruptured intracranial aneurysms: Study protocol. Int J Stroke. 2018 Dec;13(9):992-998. doi: 10.1177/1747493018790033. Epub 2018 Jul 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aneurysm rupture or growth	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)	36 months
Secondary	aneurysm volume	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)	36 months
Secondary	new aneurysm	development of de novo aneurysm on serial imaging	36 months
Secondary	therapy of aneurysm	clipping/coiling during the study period	36 months
Secondary	stroke	any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging	36 months
Secondary	myocard infarction	myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography	36 months
Secondary	vascular death	vascular death (including fatal stroke, fatal myocardial infarction, sudden death)	36 months
Secondary	major bleeding	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	36 months
Secondary	death	death from all other causes	36 months
Secondary	achieved blood pressure	any data on blood pressure management used	36 months
Secondary	Incidence of Treatment-Emergent Adverse and Serious Adverse Events	all adverse and serious adverse events related to the experimental intervention	36 months