A Phase 3 interventional study of Acetylsalicylic acid and intensive blood pressure control in Unruptured Intracranial Aneurysms, sponsored by Universitätsmedizin Mannheim. Status unknown at 18 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-25.
Sponsored by Universitätsmedizin Mannheim · Phase 3, Interventional, and Prevention
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)
427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.
This study's planned enrollment of 776 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.
Browse Intracranial Aneurysm studies →Universitätsmedizin Mannheim is the lead sponsor of 75 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
Drug: Acetylsalicylic acid · Other: intensive blood pressure control
blood pressure management according to guidelines
100 mg daily as one tablet
Also known as: aspirin
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.
aneurysm rupture or growth
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)
Time frame: 36 months
aneurysm volume
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)
Time frame: 36 months
new aneurysm
development of de novo aneurysm on serial imaging
Time frame: 36 months
therapy of aneurysm
clipping/coiling during the study period
Time frame: 36 months
stroke
any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging
Time frame: 36 months
myocard infarction
myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography
Time frame: 36 months
vascular death
vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
Time frame: 36 months
major bleeding
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
Time frame: 36 months
death
death from all other causes
Time frame: 36 months
achieved blood pressure
any data on blood pressure management used
Time frame: 36 months
Incidence of Treatment-Emergent Adverse and Serious Adverse Events
all adverse and serious adverse events related to the experimental intervention
Time frame: 36 months
Plan to share: Undecided
This study is status unknown, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Universitätsmedizin Mannheim