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

NCT03063541 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2019-01-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • UMC Utrecht

    collaborator OTHER

  • Schwiete Stiftung, Mannheim, Germany

    collaborator UNKNOWN

  • KKS Netzwerk

    collaborator NETWORK

  • University of Hamburg-Eppendorf

    collaborator OTHER

  • Universitätsmedizin Mannheim

    lead OTHER

Principal Investigators

  • Nima Etminan, PD Dr. · UMM, Department of Neurosurgery

  • Mervyn D Vergouwen, MD,PhD · UMC Utrecht, Department of Neurology and Neurosurgery

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063541 on ClinicalTrials.gov