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Propective-Randomised Open-label Trial to Evaluate risk faCtor management in patients with Unruptured intracranial aneurysms – PROTECT-U
Propective-Randomised Open-label Trial to Evaluate risk faCtor Management in Patienten mit Unrupturierten intrakraniellen Aneurysmen – PROTECT-U
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Veröffentlicht: | 8. Mai 2019 |
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Objective: Unruptured intracranial aneurysms (UIA) 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. We aim to investigate in patients with an UIA who do not qualify for preventive endovascular or neurosurgical intervention whether a treatment strategy with acetylsalicylic acid (ASA) and intensive blood pressure (BP) reduction reduces the risk of aneurysm rupture or growth, compared to standard of care.
Methods: PROTECT-U is an international, multicentre, prospective, randomised, open-label phase III trial with blinded outcome assessment. Patients, 18 years or older, with an intradural, saccular UIA on MR or CT angiography are eligible, if it is decided to refrain from preventive endovascular or neurosurgical intervention, and to monitor the aneurysm on a regular basis for growth. We hypothesize that a treatment strategy consisting of ASA 100mg/day plus intensive BP treatment (targeted systolic BP<120mmHg, monitored with a home BP measuring device) reduces the risk of aneurysm rupture or growth compared with standard care (no ASA, targeted systolic BP<140mmHg, no home BP measuring device). The primary outcome is aneurysm rupture or growth (increase in any aneurysm diameter by ?≥1mm) on repeated MR or CT angiography within 36±6 months after randomization. We aim to randomize 776 patients 1:1 to the intervention arm or care as usual.
Results: The trial was initiated in 2017 and in November 29th, 2018, a total of 100 patients were included in Germany and The Netherlands. The aneurysm size distributions are: 9.1 mm=2. To date no severe adverse events related to the experimental treatment were detected.
Conclusion: The PROTECT-U trial is the first ever randomized Phase III trial to investigate whether a medical strategy reduces the risk of rupture or growth of intracranial aneurysms in patients not undergoing preventive endovascular or neurosurgical aneurysm treatment.