Stroke, AcuteobservationNCT06371495
Statins Role in Acute Ischemic Stroke
An observational study of Stroke, Acute, run by Assiut University.
Trial summary
Strokes is amajor cause of death and disabilities in different countried Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- rosuvastatin
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2024to 30 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Adult, Older adult
Study population: people have acute ischemic stroke
Who may be able to join
- .patients.have acute ischemic stroke within 24 hours of onset. 2.patient not received intravenous thrombolysis or mechanical thrombectomy3.patients with no contraindications or hypersensitivity to statins
Who cannot join
- 1. Patient received IV thrombolysis or underwent mechanical thrombectomy 2. patient have acute ischemic stroke with onset of more than 24 hours 3.patients have hypersestivty or contraindication to statin 4:patients refuse to participate in the study
About this study
Official title: Statins in Acute Ischemic Stroke(Role of Statins in Reperfusion in Acute Stroke )
Strokes is amajor cause of death and disabilities in different countried
Read the detailed description
Stroke is a major cause of mortality and disability in modern societies. Statins are effective medications in decreasing cardiovascular events through lipid lowering and pleiotropic effects. Ischemic stroke is burdened with a high morbidity and mortality in our society. However, there are few effective and largely available therapies for this devastating disease. In additon to advancing acute reperfusion therapies, there is a need to develop treatments aimed to promote repair and regeneration of brain tissue damaged by ischemia (neurorecovery)(1,2,3). Therapeutic angiogenesis and vasculogenesis represent novel approaches of regenerative medicine that may help in the cure of patients with acute ischemic stroke. Translation of our knowledge about these processes from the bench to bedside is still underway. Although angiogenesis (the sprouting of new blood vessels from pre-existing vascular structures) is likely to contribute to neurorepair, the finality of the angiogenic response in acute ischemic stroke has not been fully elucidated. The first therapeutic approach to angiogenesis after ischemic stroke would be the modulation of the endogenous angiogenic response. In this setting, early instauration of physical activity, statins, and peroxisome proliferator-activated receptor-γ agonists may enhance angiogenesis and neuroregeneration Statins have been shown to improve the functional outcome of patients after an ischemic stroke. We hypothesized that daily statin intake improves functional outcome after an acute ischemic stroke (4,5,6,7,8) Duplex sonography is the best noninvasive modality for investigation of possible carotid artery stenosis to evaluate the intema media thickness of carotid artery in patients of acute ischemic stroke before and after receiving high dose of statins to evaluate its effectiveness in management and appropriate dose of statins (9.10.11.12,13,14)
- Conditions
- Stroke, Acute
- Being tested
- rosuvastatin
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rosuvastatinDrug
Also called ststins
Stude include three groupsof people GroupA: recieve rosuvastatin 40mg Group B :recive rosuvastatin 20mg Group C: recive placebo 2- Follow up will be done using NIHSS at the onset and modified Rankin scale at the onset and after 1 month and 3 months of the onset.
3- Carotid duplex will be done at the onset and after 1 month and 3 months of the onset.
| Study group | Role | What they receive |
|---|---|---|
| Group ABC | GroupA: recieve rosuvastatin 40mg Receives: Drug: rosuvastatin | |
| Group B | Group B :recive rosuvastatin20 Receives: Drug: rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid duplex will be done at the onset and after 1 month and 3 months of the onset.
measure the carotid thickness through Carotid duplex
Measured: first day and after 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start13 Aug 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Mohamed Sedeq, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371495
- Sponsor's protocol ID
- statins in ischemic stroke
- Acronym
- observation
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gandhi BS, Kanungo MS. Effect of cortisone on monoamine oxidase of the liver of young & old rats. Indian J Biochem Biophys. 1974 Jun;11(2):102-4. No abstract available.
PubMed 4448456
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins in Acute Ischemic Stroke(Role of Statins in Reperfusion in Acute Stroke )
- ClinicalTrials.gov ID
- NCT06371495
- Acronym / sponsor ID
- observation / statins in ischemic stroke
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 13 Aug 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strokes is amajor cause of death and disabilities in different countried
Detailed description
Stroke is a major cause of mortality and disability in modern societies. Statins are effective medications in decreasing cardiovascular events through lipid lowering and pleiotropic effects. Ischemic stroke is burdened with a high morbidity and mortality in our society. However, there are few effective and largely available therapies for this devastating disease. In additon to advancing acute reperfusion therapies, there is a need to develop treatments aimed to promote repair and regeneration of brain tissue damaged by ischemia (neurorecovery)(1,2,3). Therapeutic angiogenesis and vasculogenesis represent novel approaches of regenerative medicine that may help in the cure of patients with acute ischemic stroke. Translation of our knowledge about these processes from the bench to bedside is still underway. Although angiogenesis (the sprouting of new blood vessels from pre-existing vascular structures) is likely to contribute to neurorepair, the finality of the angiogenic response in acute ischemic stroke has not been fully elucidated. The first therapeutic approach to angiogenesis after ischemic stroke would be the modulation of the endogenous angiogenic response. In this setting, early instauration of physical activity, statins, and peroxisome proliferator-activated receptor-γ agonists may enhance angiogenesis and neuroregeneration Statins have been shown to improve the functional outcome of patients after an ischemic stroke. We hypothesized that daily statin intake improves functional outcome after an acute ischemic stroke (4,5,6,7,8) Duplex sonography is the best noninvasive modality for investigation of possible carotid artery stenosis to evaluate the intema media thickness of carotid artery in patients of acute ischemic stroke before and after receiving high dose of statins to evaluate its effectiveness in management and appropriate dose of statins (9.10.11.12,13,14)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ABC | – | Drug: rosuvastatinGroupA: recieve rosuvastatin 40mg |
| Group B | – | Drug: rosuvastatinGroup B :recive rosuvastatin20 |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- people have acute ischemic stroke
Key inclusion criteria (1 listed)
- .patients.have acute ischemic stroke within 24 hours of onset. 2.patient not received intravenous thrombolysis or mechanical thrombectomy3.patients with no contraindications or hypersensitivity to statins
Key exclusion criteria (1 listed)
- 1. Patient received IV thrombolysis or underwent mechanical thrombectomy 2. patient have acute ischemic stroke with onset of more than 24 hours 3.patients have hypersestivty or contraindication to statin 4:patients refuse to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rosuvastatinAlso: ststinsStude include three groupsof people GroupA: recieve rosuvastatin 40mg Group B :recive rosuvastatin 20mg Group C: recive placebo 2- Follow up will be done using NIHSS at the onset and modified Rankin scale at the onset and after 1 month and 3 months of the onset. 3- Carotid duplex will be done at the onset and after 1 month and 3 months of the onset. | Drug | Group ABC, Group B |
Primary outcome
Carotid duplex will be done at the onset and after 1 month and 3 months of the onset.
Time frame: first day and after 3 mounths
measure the carotid thickness through Carotid duplex
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Results publication: PubMed 4448456Gandhi BS, Kanungo MS. Effect of cortisone on monoamine oxidase of the liver of young & old rats. Indian J Biochem Biophys. 1974 Jun;11(2):102-4. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid duplex will be done at the onset and after 1 month and 3 months of the onset. (time frame: first day and after 3 mounths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06371495, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.