NCT03063541

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 776 (estimated)
• Sponsor: Universitätsmedizin Mannheim · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Unruptured Intracranial Aneurysms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-21
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2017-02-24
• Last updated: 2019-01-25

Locations

18 sites across 2 countries: Germany, Netherlands