Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms (PROTECT-U)

January 23, 2019 updated by: Nima Etminan, Universitätsmedizin Mannheim

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

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
776

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • Klinik für Neurochirurgie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gerrit A Schubert, Prof. Dr.
      • Berlin, Germany, 13353
        • Recruiting
        • Neurochirurgische Klinik
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Vajkoczy, Prof. Dr.
      • Düsseldorf, Germany, 40225
        • Recruiting
        • Neurochirurgische Klinik
        • Contact:
        • Contact:
          • Kerim Beseoglu, Dr.
      • Erlangen, Germany, 91054
      • Essen, Germany, 45147
        • Recruiting
        • Klinik für Neurochirurgie
        • Contact:
        • Principal Investigator:
          • Ramazan Jabbarli, PhD
      • Göttingen, Germany, 37037
      • Hamburg, Germany, 20246
        • Recruiting
        • Klinik für Neurochirurgie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nils O Schmidt, PD Dr.
      • Heidelberg, Germany, 69120
        • Recruiting
        • Neurologische Universitatsklinik
        • Contact:
          • Peter A Ringleb, Prof. Dr.
          • Phone Number: 8243 +496221 56-
        • Contact:
        • Principal Investigator:
          • Peter A Ringleb, Prof. Dr.
      • Mannheim, Germany, 68167
        • Recruiting
        • Department of Neurosurgery, University Hospital Mannheim
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nima Etminan, PD Dr.med.
        • Sub-Investigator:
          • Daniel Haenggi, Prof. Dr.med.
      • München, Germany, 81675
        • Active, not recruiting
        • Neurochirurgische Klinik und Poliklinik
      • Münster, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster
        • Contact:
        • Principal Investigator:
          • Markus Holling, MD PhD
    • Hessen
      • Frankfurt am Main, Hessen, Germany
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Recruiting
        • AMC Department of Neurology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yvo Roos, Prof. Dr.
      • Groningen, Netherlands
        • Recruiting
        • UMCG
        • Contact:
        • Principal Investigator:
          • Maarten Uyttenboogaart, Dr.
      • Leiden, Netherlands, 2300 RC
        • Recruiting
        • Leiden University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marieke JH Wermer, MD PhD FESO
      • Nijmegen, Netherlands, 6500 GS
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC
        • Contact:
        • Principal Investigator:
          • Bob Roozenbeek, MD PhD
      • Utrecht, Netherlands

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years or older with an intradural, saccular unruptured aneurysm (UIA) in whom it is decided not to intervene with preventive endovascular or neurosurgical repair of the aneurysm and who are monitored on a regular base for aneurysm growth
  • Last aneurysm imaging with either CTA/MRA/DSA within the last 3 months

Exclusion Criteria:

  • All non-saccular UIAs or aneurysms related to arteriovenous malformations
  • Frequent ASA use and/or indication for a vitamin K antagonist, or direct oral anticoagulant (DOAC) treatment at baseline
  • Contra-indication for ASA
  • History of hypersensitivity to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
  • Chronic kidney disease stage IV and V (GFR < 30 mL/min/1.73 m2)
  • Pregnancy and lactation
  • Participation in another clinical trial or observation period of competing trials, respectively
  • Life-expectancy <3 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acetylsalicylic acid, BP-target 120
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
Drug: Acetylsalicylic acid
100 mg daily as one tablet
Other Names:
  • aspirin
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.
No Intervention: standard care
blood pressure management according to guidelines

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
36 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
36 months
new aneurysm
Time Frame: 36 months
development of de novo aneurysm on serial imaging
36 months
therapy of aneurysm
Time Frame: 36 months
clipping/coiling during the study period
36 months
stroke
Time Frame: 36 months
any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging
36 months
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
36 months
vascular death
Time Frame: 36 months
vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
36 months
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
36 months
death
Time Frame: 36 months
death from all other causes
36 months
achieved blood pressure
Time Frame: 36 months
any data on blood pressure management used
36 months
Incidence of Treatment-Emergent Adverse and Serious Adverse Events
Time Frame: 36 months
all adverse and serious adverse events related to the experimental intervention
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsmedizin Mannheim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
UMC Utrecht
University of Hamburg-Eppendorf
KKS Netzwerk
Schwiete Stiftung, Mannheim, Germany

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nima Etminan, PD Dr., UMM, Department of Neurosurgery
  • Principal Investigator: Mervyn D Vergouwen, MD,PhD, UMC Utrecht, Department of Neurology and Neurosurgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROTECT-U_V2.2_20_Feb_2017
  • 2017-000514-35 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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