Related Experiment Video
Updated: Feb 7, 2026
Author Spotlight: Advancements and Challenges in Surgical Treatments for Postamputation Pain
Published on: March 8, 2024
Prospective Randomized Open-label Trial to evaluate risk faCTor management in patients with Unruptured intracranial
Mervyn DI Vergouwen1, Gabriel Je Rinkel1, Ale Algra1,2
11 Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Centre Utrecht, Utrecht University, Utrecht, the Netherlands.
Rationale:
Unruptured intracranial aneurysms are currently left untreated if the presumed complication risk of preventive endovascular or neurosurgical intervention is higher than the risk of rupture. Aneurysm wall inflammation and blood pressure are attractive modifiable risk factors of aneurysm rupture and growth.
Aim:
To investigate in patients with an unruptured intracranial aneurysm who do not qualify for preventive endovascular or neurosurgical intervention whether a treatment strategy of acetylsalicylic acid 100 mg/day plus intensive blood pressure treatment (targeted systolic blood pressure < 120 mmHg, monitored with a home blood pressure measuring device) reduces the risk of aneurysm rupture or growth compared with care as usual (no acetylsalicylic acid, targeted office systolic blood pressure < 140 mmHg, no home blood pressure measuring device).
Sample Size:
We aim to randomize 776 patients 1:1 to the intervention arm or care as usual.
Design:
Bi-national (Germany and the Netherlands) multicenter, prospective, randomized, open-label phase III trial with blinded outcome assessment.
Outcomes:
The primary outcome is aneurysm rupture or growth (increase in any aneurysm diameter by ≥ 1 mm) on repeated MR or CT angiography within 36 ± 6 months after randomization.
Discussion:
The Prospective Randomized Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U) is the first randomized trial to investigate if a medical strategy reduces the risk of rupture or growth of intracranial aneurysms in patients not undergoing preventive endovascular or neurosurgical aneurysm treatment. Clinical trial Registration: NCT03063541.
More Related Videos
11:58Minimally Invasive Thumb-sized Pterional Craniotomy for Surgical Clip Ligation of Unruptured Anterior Circulation Aneurysms
Published on: August 11, 2015
03:07Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Related Concept Videos
01:26Factors Affecting the Risk of Infection
The integrity and count of the white blood cells help the body resist pathogens and fight infection. When impaired, it reduces the body's resistance to pathogens. The acidic pH levels of the gastrointestinal, genitourinary tracts, and skin...
01:22Aneurysm IV: Nursing Management
01:29Factors Affecting Protein-Drug Binding: Patient-Related Factors
Age stands as a key determinant in protein-drug binding. Neonates, characterized by low albumin content, experience heightened concentrations of unbound drugs such as phenytoin and...
01:21Aneurysm II: Clinical Manifestations and Diagnostic Studies
01:20Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
01:29Appendicitis-II: Diagnostic Studies and Management
Diagnosing Appendicitis
It requires a multifaceted approach, starting with a detailed physical examination to pinpoint the location and nature of the pain and identify any associated symptoms. Laboratory tests play a crucial role. A complete Blood Count (CBC) typically reveals leukocytosis (an increased number of...