Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms (PROTECT-U)

Universitätsmedizin Mannheim

Status and phase: Unknown; Phase 3

Conditions: Unruptured Intracranial Aneurysms

Treatments: Drug: Acetylsalicylic acid; Other: intensive blood pressure control

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT03063541

PROTECT-U_V2.2_20_Feb_2017

2017-000514-35 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment: 776 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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776 participants in 2 patient groups

Acetylsalicylic acid, BP-target 120

Experimental group

Description:

100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg

Treatment:

Other: intensive blood pressure control

Drug: Acetylsalicylic acid

standard care

No Intervention group

Description:

blood pressure management according to guidelines