Study on the Effects of Continuing or Stopping Simvastatin and Atorvastatin in Patients with Spontaneous Lobar Intracerebral Hemorrhage

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What is this study about?

This clinical trial is focused on studying the effects of certain medications called statins in patients who have experienced a type of stroke known as intracerebral hemorrhage (ICH). Statins, such as simvastatin and atorvastatin, are commonly used to lower cholesterol levels in the blood. The study aims to understand the impact of continuing or stopping the use of statins on the risk of having another ICH. Additionally, the study will look at the effects of stopping statins on the risk of major heart and blood vessel problems, such as heart attacks and strokes.

Participants in the study will be monitored over a period of 24 months. During this time, researchers will compare the outcomes of those who continue taking statins with those who stop. The study will also assess the quality of life and cognitive functions, which relate to thinking and memory, using tools like the EQ-5D questionnaire and the Telephone Montreal Cognitive Assessment (T-MoCA). The study will also explore the role of certain genetic factors, specifically the APOE gene, in the risk of having another ICH.

The goal of this research is to provide better guidance on the use of statins in patients who have had an ICH, helping to balance the benefits of cholesterol management with the potential risks of recurrent bleeding in the brain. This information could be crucial for doctors and patients in making informed decisions about the continuation or discontinuation of statin therapy after an ICH.

1 joining the study

Upon joining the study, eligibility is confirmed. This includes being 50 years or older, having a spontaneous lobar intracerebral hemorrhage (ICH) confirmed by a CT or MRI scan, and having been on a statin drug at the time of the ICH.

Randomization occurs within 7 days of the ICH onset. Agreement to be randomized to either continue or discontinue statin use is required.

2 randomization

Participants are randomly assigned to one of two groups: statin continuation or statin discontinuation.

The purpose is to compare the effects of continuing versus stopping statin use on the risk of recurrent ICH and other health events.

3 medication administration

If assigned to the statin continuation group, participants will continue taking their prescribed statin medication. This could be one of the following: Simvastatin 10 mg, 20 mg, or 40 mg, or Atorvastatin 10 mg, 20 mg, 40 mg, or 60 mg. All medications are taken orally as film-coated tablets.

If assigned to the statin discontinuation group, participants will stop taking their statin medication.

4 follow-up period

The follow-up period lasts for 24 months. During this time, the effects of continuing or discontinuing statins on the risk of recurrent symptomatic ICH and major adverse cardiac and cerebrovascular events (MACCE) are monitored.

MACCE includes events such as ischemic stroke, myocardial infarction, and vascular death.

5 assessment of outcomes

Primary outcomes focus on the risk of recurrent ICH and the occurrence of MACCE.

Secondary outcomes include quality of life, cognitive and functional outcomes, assessed through questionnaires and scales such as the EQ-5D, modified Rankin Scale (mRS), and Telephone Montreal Cognitive Assessment (T-MoCA).

The study also examines the effects of specific genetic factors on the risk of recurrent ICH.

Who Can Join the Study?

Must be 50 years old or older.
Must have had a spontaneous lobar ICH, which is a type of bleeding in the brain, confirmed by a CT or MRI scan. These are special imaging tests that take pictures of the inside of your body.
Must have been taking a statin drug at the time the brain bleeding started. Statins are medications used to lower cholesterol.
Must be able to start the study within 7 days of the brain bleeding event.
Must agree, after talking with the doctors who prescribed the statin, to be randomly assigned to either continue or stop taking the statin.

Who Cannot Join the Study?

Patients who have not experienced a spontaneous lobar ICH (a type of bleeding in the brain that occurs without any obvious cause).
Patients who are not currently taking a statin drug (a medication used to lower cholesterol levels).
Patients who are under the age of 18.
Patients who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain

Other Sites

Site Name	City	Country
Hospital Del Mar	Barcelona	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario Torrecardenas	Almeria	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Fundacio Institut De Recerca De L’Hospital De La Santa Creu I Sant Pau	Barcelona	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Hkabmcxj Ukjfzvshpgapw Dp Ld Pkdtqrsw	Madrid	Spain
Hwbpkqwf Uowgiowgqtgql De Bsmvhjz	Badajoz	Spain
Pigu Twpwj Hfenccux Uqttgdvktqfw	Sabadell	Spain
Hfbmydtq Uopragrgracsf Dcpiummt	Donostia / San Sebastian	Spain
Fetiqvvtk Pvyf La Imcqpsqlwgrwb Bimbltntp Djg Hxrvdeom Ufpktwvxwwraa Lf Pth	Madrid	Spain
Haqeahcl Uqnqajgjpetlx Hjpchsbu Thyay y Ptxrxl Iwgwvyoq Cvzcom djgyxqjflqeikibvw (gcul	Badalona	Spain
Hppyaxiw Vmod dqxzlpdp	Barcelona	Spain
Hswleiox Uavvoztcwtzfd df A Cwhvie	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	21.09.2022

Trial locations

Investigated drugs:

Statins are medications used to lower cholesterol levels in the blood. They work by blocking a substance your body needs to make cholesterol, which can help prevent heart disease and stroke. In this clinical trial, the focus is on understanding the effects of continuing or stopping statins in patients who have experienced a type of stroke called intracerebral hemorrhage. The trial aims to see if stopping statins reduces the risk of having another stroke and to assess the safety of stopping statins in terms of other heart and blood vessel problems.

Investigated diseases:

Cerebral haemorrhage

Spontaneous Lobar Intracerebral Hemorrhage (ICH) – This condition involves bleeding within the brain’s lobes, occurring without any apparent cause such as trauma. It typically results from the rupture of small blood vessels, often linked to high blood pressure or amyloid angiopathy. The bleeding can lead to increased pressure in the brain, causing symptoms like sudden headache, weakness, or changes in vision or speech. As the hemorrhage progresses, it may result in more severe neurological deficits, depending on the location and size of the bleed. Over time, the body may reabsorb the blood, but the initial damage can lead to lasting impairments. The risk of recurrence is a significant concern, especially in individuals with underlying conditions that predispose them to bleeding.

Trial ID:

2024-511465-11-00

Protocol code:

SATURN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Continuing or Stopping Simvastatin and Atorvastatin in Patients with Spontaneous Lobar Intracerebral Hemorrhage

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?