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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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)

Detailed Summary:
Sponsor: Universitätsmedizin Mannheim

Current Primary Outcome: aneurysm rupture or growth [ Time Frame: 36 months ]

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)


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome:

  • aneurysm volume [ Time Frame: 36 months ]
    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)
  • new aneurysm [ Time Frame: 36 months ]
    development of de novo aneurysm on serial imaging
  • therapy of aneurysm [ Time Frame: 36 months ]
    clipping/coiling during the study period
  • stroke [ Time Frame: 36 months ]
    any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging
  • myocard infarction [ Time Frame: 36 months ]
    myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography
  • vascular death [ Time Frame: 36 months ]
    vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
  • major bleeding [ Time Frame: 36 months ]
    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
  • death [ Time Frame: 36 months ]
    death from all other causes
  • achieved blood pressure [ Time Frame: 36 months ]
    any data on blood pressure management used
  • safety [ Time Frame: 36 months ]
    adverse and serious adverse events


Information By: Universitätsmedizin Mannheim

Dates:
Date Received: February 20, 2017
Date Started: July 2017
Date Completion: December 2022
Last Updated: February 23, 2017
Last Verified: February 2017