Study on Managing Risk Factors in Patients with Unruptured Brain Aneurysms Using Carbasalate Calcium and Intensive Blood Pressure Treatment

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What is this study about?

This clinical trial is focused on studying the management of risk factors in patients with unruptured intracranial aneurysms. An aneurysm is a bulge in a blood vessel in the brain that has not burst. The study will use a treatment strategy involving low-dose Acetylsalicylic Acid (commonly known as aspirin) and intensive blood pressure management. The goal is to see if this approach can reduce the risk of the aneurysm growing or rupturing compared to standard care, which typically involves no aspirin and less frequent blood pressure monitoring.

Participants in the study will be randomly assigned to one of two groups. One group will receive low-dose aspirin and will aim to keep their systolic blood pressure (the top number in a blood pressure reading) below 120 mmHg, with weekly checks using a home blood pressure monitor. The other group will receive standard care, which usually involves treating high blood pressure only if it exceeds 140 mmHg, without the use of aspirin or regular home monitoring. The study will last for a period of up to 120 days, during which participants will be monitored for any changes in their aneurysms through imaging tests like MRI or CT scans.

The primary aim of the study is to determine if the new treatment strategy can effectively reduce the risk of aneurysm rupture or growth. Secondary outcomes will also be observed, such as any changes in aneurysm size or shape, the development of new aneurysms, and any related health events like strokes or heart attacks. The study will also assess the overall safety of the treatment and its impact on participants’ quality of life.

1 joining the study

Upon joining the study, the patient must have at least one unruptured aneurysm and be regularly monitored for aneurysm growth.

The patient must be 18 years or older and have had recent imaging of the aneurysm within the last three months.

The patient must provide written informed consent and, if applicable, use adequate contraception.

2 medication and blood pressure management

The patient will be assigned to a treatment strategy involving low-dose acetylsalicylic acid (81-100 mg per day) and intensive blood pressure management.

The goal is to maintain systolic blood pressure below 120 mmHg, with weekly measurements using a home blood pressure device.

3 standard care group

If assigned to the standard care group, the patient will not receive acetylsalicylic acid and will manage blood pressure according to standard guidelines, which typically recommend treatment if systolic blood pressure exceeds 140 mmHg.

No home device for weekly blood pressure measurements will be provided.

4 monitoring and follow-up

The primary outcome is the rupture or growth of the aneurysm, assessed through regular imaging.

Secondary outcomes include any aneurysm growth or rupture, changes in aneurysm volume or shape, development of new aneurysms, and any related medical events such as stroke or heart attack.

5 trial duration

The trial is expected to continue until June 2029.

The patient’s participation will involve regular follow-ups and assessments throughout the trial period.

Who Can Join the Study?

The patient must have at least one intradural saccular unruptured aneurysm. This means there is a bulge in a blood vessel in the brain that hasn’t burst.
The patient should be 18 years or older.
The patient must have had a recent imaging test, like a CTA (a special type of X-ray) or MRA (a type of MRI), within the last 3 months to check the aneurysm.
The patient should be able to understand the nature and personal impact of the clinical trial.
The patient must not be legally incapacitated, meaning they should be able to make their own decisions.
The patient needs to provide written informed consent, which is a document that shows they agree to participate in the trial.
For women who can have children, they must use adequate contraception to prevent pregnancy during the trial.

Who Cannot Join the Study?

Patients with a history of allergic reactions to ASA (Aspirin) cannot participate. An allergic reaction is when your body reacts badly to a substance, causing symptoms like rash or difficulty breathing.
Individuals who have bleeding disorders are excluded. A bleeding disorder is a condition where your blood doesn’t clot properly, leading to excessive bleeding.
People currently taking blood thinners are not eligible. Blood thinners are medications that help prevent blood clots but can increase the risk of bleeding.
Patients with uncontrolled high blood pressure cannot join. This means their blood pressure is consistently higher than what is considered safe, even with treatment.
Those with severe kidney disease are excluded. Severe kidney disease means the kidneys are not working well enough to filter waste from the blood.
Individuals with liver disease that affects liver function cannot participate. The liver is an organ that helps process nutrients and filter toxins from the blood.
Pregnant women are not eligible for the study.
People under the age of 18 or over the age of 80 are excluded from participating.
Patients who are unable to give informed consent are not eligible. Informed consent means understanding the study and agreeing to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Kuopio University Hospital	Kuopio	Finland
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Aachen AöR	Aachen	Germany
Oulu University Hospital	Oulu	Finland
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
Turku University Hospital	Turku	Finland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Medical Center Haaglanden	Leidschendam	The Netherlands
Pirkanmaan hyvinvointialue	Tampere	Finland
Umgthejlukxuukqdzycgj Edfcx Aie	Essen	Germany
Uecunpnouwxl Mopyfet Ccpebkc Gttyurvra	Groningen	The Netherlands
Uiywhfxfbyzkctjqamjxu Dfcmfgujaok Alg	Duesseldorf	Germany
Hfsvpmzv Uzeckjkldl Cynyjij Hbnvazvo	Helsinki	Finland
Esyasex Uybcxsgmibqg Mspzqcv Cadhbzs Rbvqoijug (xhnopqa Mbo	Rotterdam	The Netherlands
Sgf Egdsitipe Helmqhej Tugckss	Tilburg	The Netherlands
Anumtmvnu Ucs	Amsterdam	The Netherlands
Gzwyss Uvonttoveg Ffbwtlddd	Frankfurt	Germany

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	21.09.2017
Germany	Recruiting	21.09.2017
The Netherlands	Recruiting	21.09.2017

Trial locations

Investigated drugs:

ASA (Aspirin) is used in this trial at a low dose. It is a medication that helps to prevent blood clots. In this study, it is being tested to see if it can reduce the risk of aneurysm rupture or growth in patients with unruptured intracranial aneurysms.

Intensive Blood Pressure Treatment involves managing blood pressure more aggressively than usual. The goal is to keep the systolic blood pressure below 120 mmHg. This is done with the help of a home blood pressure measuring device, which allows patients to monitor their blood pressure weekly. The study is examining whether this approach can lower the risk of aneurysm complications compared to standard blood pressure management.

Investigated diseases:

Intracranial aneurysm

Intradural Saccular Unruptured Aneurysm – This condition involves a bulging, balloon-like dilation in the wall of a blood vessel within the brain, specifically located inside the dura mater, which is the outermost membrane covering the brain. These aneurysms are saccular, meaning they have a sac-like appearance, and are unruptured, indicating they have not yet burst. Over time, the aneurysm may grow larger, increasing the risk of rupture, which can lead to bleeding in the brain. The progression of this condition can be monitored through imaging techniques like MR or CT angiography to detect any changes in size or shape. Factors such as blood pressure and lifestyle may influence the growth or stability of the aneurysm. Regular monitoring is crucial to assess any potential changes that might require medical intervention.

Trial ID:

2024-517236-22-00

Protocol code:

PROTECT-U

NCT ID:

NCT03063541

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Managing Risk Factors in Patients with Unruptured Brain Aneurysms Using Carbasalate Calcium and Intensive Blood Pressure Treatment

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?