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出境医 / 临床实验 / Statins In Intracerbral Hemorrhage (SATURN)

Statins In Intracerbral Hemorrhage (SATURN)

Study Description
Brief Summary:
The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype.

Condition or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Statins Phase 3

Detailed Description:

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized at 1:1 ratio to either continue the same statin drug and dosage that they are taking at the time of ICH onset or to discontinue it for up to 24 months after ICH. No placebo will be prescribed for those randomized to discontinue statins.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : December 31, 2026
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Statin
The same statin agent and dose that subjects were using at the time of ICH onset.
 Drug: Statins
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
Other Name: HMG CoA
No Intervention: No-statin
Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
Outcome Measures
Primary Outcome Measures :
  1. Recurrent symptomatic ICH [ Time Frame: within 24 months ]

Secondary Outcome Measures :
  1. Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 50 years.
  2. Spontaneous lobar ICH confirmed by CT or MRI scan
  3. Patient was taking a statin drug at the onset of the qualifying/index ICH
  4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
  5. Patient or legally authorized representative, after consultation with physicians, agrees to be randomized to statin continuation (restart) vs. discontinuation

Exclusion Criteria:

  1. Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
  2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
  3. Diabetic patients with history of myocardial infarction or coronary revascularization
  4. History of familial hypercholesterolemia
  5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
  6. Known diagnosis of severe dementia
  7. Inability to obtain informed consent
  8. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
  9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
  10. Pre-morbid mRS >3
  11. ICH score >3 upon presentation.
  12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
  13. Woman of childbearing potential
  14. Concurrent participation in another research protocol for investigation of experimental therapy.
  15. Indication that withdrawal of care will be implemented for the qualifying ICH.
Contacts and Locations

Contacts
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Contact: Magdy Selim, MD, PhD 617-632-8913 mselim@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Magdy Selim, MD, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
NINDS Stroke Trials Network (StrokeNet)
Canadian Stroke Consortium (CSC)
University of Cincinnati
Medical University of South Carolina
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 3, 2019
Last Update Posted Date June 24, 2020
Actual Study Start Date  ICMJE June 10, 2020
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		Recurrent symptomatic ICH [ Time Frame: within 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2019) 		Major Adverse Cerebro- and Cardio-Vascular Events [ Time Frame: Within 24 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statins In Intracerbral Hemorrhage
Official Title  ICMJE STATINS USE IN INTRACEREBRAL HEMORRHAGE PATIENTS
Brief Summary The SATURN trial aims to determine whether continuation vs. discontinuation of statin drugs after spontaneous lobar intracerebral hemorrhage (ICH) is the best strategy; and whether the decision to continue/discontinue statins should be influenced by an individual's Apolipoprotein-E (APOE) genotype.
Detailed Description

SATURN is a multi-center, pragmatic, prospective, randomized, open-label, and blinded end-point assessment (PROBE) clinical trial. A total of 1,456 patients presenting within 7 days of a spontaneous lobar ICH while taking statins will be randomized to one of two treatment strategies: discontinuation vs. continuation of statin therapy (using the same agent and dose that they were using at ICH onset). Participating subjects will undergo baseline testing for APOE genotype and will be followed for 24 months to assess for the occurrence of recurrent symptomatic ICH or major adverse cerebro-/cardio-vascular events (MACCE) during the follow-up period.

Recruitment will take place at ~ 140 sites coordinated through the NIH/NINDS StrokeNet and the Canadian Stroke Consortium.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants will be randomized at 1:1 ratio to either continue the same statin drug and dosage that they are taking at the time of ICH onset or to discontinue it for up to 24 months after ICH. No placebo will be prescribed for those randomized to discontinue statins.
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intracerebral Hemorrhage
Intervention  ICMJE Drug: Statins
Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
Other Name: HMG CoA
Study Arms  ICMJE
  • Active Comparator: Statin
    The same statin agent and dose that subjects were using at the time of ICH onset.
    Intervention: Drug: Statins
  • No Intervention: No-statin
    Subjects will discontinue the statin agent that they were taking at the time of ICH onset. No placebo will be prescribed for these subjects.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 1, 2019) 		1456
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date June 30, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 50 years.
  2. Spontaneous lobar ICH confirmed by CT or MRI scan
  3. Patient was taking a statin drug at the onset of the qualifying/index ICH
  4. Randomization can be carried out within 7 days of the onset of the qualifying ICH
  5. Patient or legally authorized representative, after consultation with physicians, agrees to be randomized to statin continuation (restart) vs. discontinuation

Exclusion Criteria:

  1. Suspected secondary cause for the qualifying ICH, such as an underlying vascular abnormality or tumor, trauma, venous infarction, or hemorrhagic transformation of an ischemic infarct.
  2. History of recent myocardial infarction (attributed to coronary artery disease) or unstable angina within the previous 3 months
  3. Diabetic patients with history of myocardial infarction or coronary revascularization
  4. History of familial hypercholesterolemia
  5. Patients receiving proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors
  6. Known diagnosis of severe dementia
  7. Inability to obtain informed consent
  8. Patients known or suspected of not being able to comply with the study protocol due to alcoholism, drug dependency, or other obvious reasons for noncompliance, such as unable to adhere to the protocol specified visits/assessments.
  9. Life expectancy of less than 24 months due to co-morbid terminal conditions.
  10. Pre-morbid mRS >3
  11. ICH score >3 upon presentation.
  12. Contraindications to continuation/resumption of statin therapy, such as significant elevations of serum creatinine kinase and/or liver transaminases, and rhabdomyolysis
  13. Woman of childbearing potential
  14. Concurrent participation in another research protocol for investigation of experimental therapy.
  15. Indication that withdrawal of care will be implemented for the qualifying ICH.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Magdy Selim, MD, PhD 617-632-8913 mselim@bidmc.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03936361
Other Study ID Numbers  ICMJE 2018C000515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Magdy Selim, Beth Israel Deaconess Medical Center
Study Sponsor  ICMJE Beth Israel Deaconess Medical Center
Collaborators  ICMJE
  • NINDS Stroke Trials Network (StrokeNet)
  • Canadian Stroke Consortium (CSC)
  • University of Cincinnati
  • Medical University of South Carolina
Investigators  ICMJE Not Provided
PRS Account Beth Israel Deaconess Medical Center
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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