HypertensionNCT04054648
BedMed-Frail: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations?
A study testing Bedtime administration of the participant's pre-existing antihypertensive medications in people with Hypertension and Dementia, run by University of Alberta at 1 site in Canada.
Trial summary
High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Dementia
- What is being tested?
- Bedtime administration of the participant's pre-existing antihypertensive medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2020to 29 Feb 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hypertension diagnosis as indicated by ≥ 2 such billing diagnoses at any time in the administrative claims data by any provider
- ≥ 1 once daily BP lowering medication
- Resident in a participating long term care facility.
Who cannot join
- Personal history of glaucoma or use of glaucoma medications. Glaucoma is an exclusion because nocturnal hypotension (i.e. excessively low blood pressure while sleeping) has been associated with ischemic optic neuropathy in such patients.
- Any patient / family member or treating physician (all of whom will be notified in advance of the LTC facilities participation in this initiative) requesting the patient not participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations? The "BedMed-Frail" Randomized Controlled Trial
High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally. A Spanish study suggests that using blood pressure pills at bedtime, instead of in the morning (when they are most commonly used), reduces death, heart attack, and stroke by more than 50%. If true, a switch to bedtime prescribing would have more impact on the health of those with high blood pressure than whether high blood pressure is treated at all.
BedMed, a community-based Canadian primary care trial, is already running and looking both to validate the findings of this Spanish study and to determine whether there might be unrecognized harms of bedtime use (such as more falls and fractures as a result of lower overnight blood pressure). One very important population that is likely to be more sensitive to the effects of medications, and almost always excluded from randomized trials, are the frail elderly (such as those who are resident in nursing homes). In order to have the greatest information about the safety and effectiveness of bedtime blood pressure medications, the BedMed team is additionally conducting a similar trial to BedMed in nursing homes ("BedMed-Frail" - the subject of this trial registration) to determine whether the risks and benefits of bedtime prescribing differ in this highly understudied population.
Basics of the trial: When patients are admitted to nursing homes, neither they nor their physicians are consulted about the timing of blood pressure medication. Unless explicitly stated to be otherwise, blood pressure pills are instead largely arbitrarily assigned for morning use by default. Given there is evidence that bedtime administration may be safer, the nursing homes participating in BedMed-Frail will have each hypertensive resident randomized to either continue with morning blood pressure medication use, as is their norm, or to have their facility's pharmacist gradually switch each residents blood pressure pills to bedtime. Over a period of roughly 3 years, health outcomes in these facilities will be tracked using routinely collected electronic health data to determine differences in things like hospitalization, death, or hip fractures - and at the end of the study the investigators hope to determine whether or not the recommendations for blood pressure medication timing in frail older adults should differ from those for the general population.
Read the detailed description
The BedMed trial (led out of the University of Alberta and funded by both Alberta Innovates Health Solutions, and the Canadian Institutes for Health Research) is a pragmatic multi-provincial trial intended to determine whether bedtime antihypertensive use, as compared to conventional morning use, reduces major adverse cardiovascular events in community dwelling primary care patients.
BedMed-Frail, led by the same group of investigators, is a complementary but separate randomized trial evaluating whether the risks and benefits of bedtime antihypertensive use differ in a long-term care (LTC) population. To accomplish this, within participating Alberta LTC and supportive living facilities, eligible residents with hypertension will be randomized at the patient level to the antihypertensive medication timing intervention (i.e. bedtime versus continued morning use). Trial outcomes and baseline characteristics are drawn from routinely collected electronic health data - using both provincial administrative health claims data and the Resident Assessment Instrument Minimum Data Set (RAI-MDS), which is a standard instrument for collecting clinical information in Canadian LTC facilities.
BedMed-Frail is event driven, receiving quarterly reporting of total events from the Alberta Support for Patient Oriented Research (SPOR) Unit's Data Platform. Funding permitting, the trial will continue until observation of 368 primary outcome events. Upon observation of half that number, an independent data safety monitoring board (IDSMB) chaired by Dr. James Wright (Cochrane Hypertension Review Group Co-ordinating Editor) will examine all available outcomes. If p is ≤ 0.001 for benefit (the Haybittle-Peto boundary - recommended to reduce the chance of stopping too early and magnifying benefit), or if p is ≤ 0.05 for harm, the IDSMB will apply clinical judgement and make recommendations to the steering committee on whether the trial should break early.
The outcomes of BedMed-Frail are primarily designed to be analogous to the cardiovascular and safety outcomes monitored for in the community BedMed study. However BedMed-Frail is also examining for differences in behaviour issues between groups. Both behavioural problems, and blood pressure, have circadian rhythms. Blood pressure is normally lower overnight and behavioural problems in long term care residents typically worsen during the same period - a phenomenon known as "sundowning". Conceivably, there could be a relationship between the two such that behaviour problems might improve, or worsen, with bedtime antihypertensive use.
- Conditions
- Hypertension, Dementia
- Being tested
- Bedtime administration of the participant's pre-existing antihypertensive medications
- Keywords
- Pragmatic, Primary Care, Chronotherapy, Administrative Data, Behaviourism, Sundowning, Stroke, Myocardial Infarction, Heart Failure, Hip Fracture, Nursing Home, Long Term Care
- Medical subject headings
- Hypertension, Dementia, Stroke, Myocardial Infarction, Heart Failure, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime administration of the participant's pre-existing antihypertensive medicationsOther
Changing the administration time of once daily blood pressure lowering medications, one at a time as tolerated, from morning to bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Bedtime Antihypertensive Medications | Active comparator | The LTC facility's pharmacist will switch all once daily antihypertensive medications, one at a time as tolerated, to bedtime. Blood pressure lowering medications taken more than once per day are left alone. Receives: Other: Bedtime administration of the participant's pre-existing antihypertensive medications |
| Morning Antihypertensive Medications | No intervention | No change to blood pressure medication timing is made. By default, most patients are using once daily antihypertensive medications in the morning at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Major Adverse Cardiovascular Events
Composite of all-cause death and hospital admission or emergency room visit for acute coronary syndrome / myocardial infarction, heart failure, or stroke - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Secondary outcomes (12)
All Cause Mortality
All cause death - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Acute Coronary Syndrome / Myocardial Infarction
Hospitalization or emergency room visit for acute coronary syndrome / myocardial infarction - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Stroke
Hospitalization or emergency room visit for stroke - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Congestive Heart Failure
Hospitalization or emergency room visit for congestive heart failure - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
All Cause Unplanned Hospitalization
All cause hospitalization or emergency room visit excluding elective surgeries or booked procedures / planned follow-up care - as recorded in governmental health claims databases
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Non-vertebral Fracture
Any physician billing (hospital or community) for a fracture other than a vertebral fracture (which might indicate a vertebral compression fracture secondary to osteoporosis, and not trauma)
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Number of Patients with a Fall in the Last 30 days
As recorded in the first quarterly Minimum Data Set (MDS) report recorded at the care facility in the 3 to 6 month window following randomization
Measured: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with "Deteriorated Cognition Relative to Status 90 Days Prior"
As recorded in the first quarterly Minimum Data Set (MDS) report recorded at the care facility in the 3 to 6 month window following randomization
Measured: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with Urinary Incontinence
As recorded in the first quarterly Minimum Data Set (MDS) report recorded at the care facility in the 3 to 6 month window following randomization. Includes "occasionally incontinent" or more frequent, which equates to 2 or more episodes per week.
Measured: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with Partial or Full Thickness Decubitus Skin Ulceration ("Bed Sores")
As recorded in the first quarterly Minimum Data Set (MDS) report recorded at the care facility in the 3 to 6 month window following randomization. Requires some degree of skin breakdown and not just erythema (i.e. stages 2 to 4).
Measured: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Acute Care Costs
Calculated from all hospitalizations using the resource intensity weight (RIW) and length of stay (LOS) as recorded in governmental health claims data
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Total Cost of Care
Acute care costs + medication costs + physician billings + nursing / facility costs as recorded in governmental health claims data. Nursing / facility costs will be estimated from level of care and duration of stay
Measured: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start25 May 2020
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Event-driven Prospective Randomized Open Blinded End-Point (PROBE) Randomized Trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Canadian Institutes of Health Research (CIHR), EnACt, Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Scott R Garrison, MD, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054648
- Sponsor's protocol ID
- Pro00086129
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2019
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Although we hope to make a de-identified participant-level version of our final analytic dataset publicly available on our website (www.PragmaticTrials.ca), and will request to do so, this requires the permission of Alberta Health Services, who must weigh the privacy concerns.
Publications
Garrison SR, Youngson ERE, Perry DA, Campbell FN, Korownyk CS, Green LA, Kolber MR, Kirkwood JEM, Allan GM, Kraut RY, McAlister FA, Hill MD, Bakal JA. Bedtime vs Morning Antihypertensive Medications in Frail Older Adults: The BedMed-Frail Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513812. doi: 10.1001/jamanetworkopen.2025.13812.
PubMed 40354050Garrison SR, Youngson E, Perry DA, Campbell FN, Kolber MR, Korownyk C, Allan GM, Green L, Bakal J. Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial. BMJ Open. 2023 Aug 1;13(8):e074777. doi: 10.1136/bmjopen-2023-074777.
PubMed 37527898
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Potential Benefit of Bedtime Antihypertensive Prescribing Extend to Frail Populations? The "BedMed-Frail" Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04054648
- Acronym / sponsor ID
- Pro00086129
- Conditions
- Hypertension, Dementia
- Keywords
- Pragmatic, Primary Care, Chronotherapy, Administrative Data, Behaviourism, Sundowning, Stroke, Myocardial Infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Innovates Health Solutions, Canadian Institutes of Health Research (CIHR), EnACt, Alberta Health services
- Study start
- 25 May 2020 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 13 Aug 2019 (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.
High blood pressure (present in 1 of 5 Canadian adults) increases the risk of heart attack and stroke. Blood pressure lowering pills reduce this risk - but perhaps not optimally. A Spanish study suggests that using blood pressure pills at bedtime, instead of in the morning (when they are most commonly used), reduces death, heart attack, and stroke by more than 50%. If true, a switch to bedtime prescribing would have more impact on the health of those with high blood pressure than whether high blood pressure is treated at all.
BedMed, a community-based Canadian primary care trial, is already running and looking both to validate the findings of this Spanish study and to determine whether there might be unrecognized harms of bedtime use (such as more falls and fractures as a result of lower overnight blood pressure). One very important population that is likely to be more sensitive to the effects of medications, and almost always excluded from randomized trials, are the frail elderly (such as those who are resident in nursing homes). In order to have the greatest information about the safety and effectiveness of bedtime blood pressure medications, the BedMed team is additionally conducting a similar trial to BedMed in nursing homes ("BedMed-Frail" - the subject of this trial registration) to determine whether the risks and benefits of bedtime prescribing differ in this highly understudied population.
Basics of the trial: When patients are admitted to nursing homes, neither they nor their physicians are consulted about the timing of blood pressure medication. Unless explicitly stated to be otherwise, blood pressure pills are instead largely arbitrarily assigned for morning use by default. Given there is evidence that bedtime administration may be safer, the nursing homes participating in BedMed-Frail will have each hypertensive resident randomized to either continue with morning blood pressure medication use, as is their norm, or to have their facility's pharmacist gradually switch each residents blood pressure pills to bedtime. Over a period of roughly 3 years, health outcomes in these facilities will be tracked using routinely collected electronic health data to determine differences in things like hospitalization, death, or hip fractures - and at the end of the study the investigators hope to determine whether or not the recommendations for blood pressure medication timing in frail older adults should differ from those for the general population.
Detailed description
The BedMed trial (led out of the University of Alberta and funded by both Alberta Innovates Health Solutions, and the Canadian Institutes for Health Research) is a pragmatic multi-provincial trial intended to determine whether bedtime antihypertensive use, as compared to conventional morning use, reduces major adverse cardiovascular events in community dwelling primary care patients.
BedMed-Frail, led by the same group of investigators, is a complementary but separate randomized trial evaluating whether the risks and benefits of bedtime antihypertensive use differ in a long-term care (LTC) population. To accomplish this, within participating Alberta LTC and supportive living facilities, eligible residents with hypertension will be randomized at the patient level to the antihypertensive medication timing intervention (i.e. bedtime versus continued morning use). Trial outcomes and baseline characteristics are drawn from routinely collected electronic health data - using both provincial administrative health claims data and the Resident Assessment Instrument Minimum Data Set (RAI-MDS), which is a standard instrument for collecting clinical information in Canadian LTC facilities.
BedMed-Frail is event driven, receiving quarterly reporting of total events from the Alberta Support for Patient Oriented Research (SPOR) Unit's Data Platform. Funding permitting, the trial will continue until observation of 368 primary outcome events. Upon observation of half that number, an independent data safety monitoring board (IDSMB) chaired by Dr. James Wright (Cochrane Hypertension Review Group Co-ordinating Editor) will examine all available outcomes. If p is ≤ 0.001 for benefit (the Haybittle-Peto boundary - recommended to reduce the chance of stopping too early and magnifying benefit), or if p is ≤ 0.05 for harm, the IDSMB will apply clinical judgement and make recommendations to the steering committee on whether the trial should break early.
The outcomes of BedMed-Frail are primarily designed to be analogous to the cardiovascular and safety outcomes monitored for in the community BedMed study. However BedMed-Frail is also examining for differences in behaviour issues between groups. Both behavioural problems, and blood pressure, have circadian rhythms. Blood pressure is normally lower overnight and behavioural problems in long term care residents typically worsen during the same period - a phenomenon known as "sundowning". Conceivably, there could be a relationship between the two such that behaviour problems might improve, or worsen, with bedtime antihypertensive use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Event-driven Prospective Randomized Open Blinded End-Point (PROBE) Randomized Trial.
| Arm | Type | Receives |
|---|---|---|
| Bedtime Antihypertensive Medications | Active comparator | Other: Bedtime administration of the participant's pre-existing antihypertensive medicationsThe LTC facility's pharmacist will switch all once daily antihypertensive medications, one at a time as tolerated, to bedtime. Blood pressure lowering medications taken more than once per day are left alone. |
| Morning Antihypertensive Medications | No intervention | –No change to blood pressure medication timing is made. By default, most patients are using once daily antihypertensive medications in the morning at baseline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertension diagnosis as indicated by ≥ 2 such billing diagnoses at any time in the administrative claims data by any provider
- ≥ 1 once daily BP lowering medication
- Resident in a participating long term care facility.
Key exclusion criteria (2 listed)
- Personal history of glaucoma or use of glaucoma medications. Glaucoma is an exclusion because nocturnal hypotension (i.e. excessively low blood pressure while sleeping) has been associated with ischemic optic neuropathy in such patients.
- Any patient / family member or treating physician (all of whom will be notified in advance of the LTC facilities participation in this initiative) requesting the patient not participate.
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 |
|---|---|---|
| Bedtime administration of the participant's pre-existing antihypertensive medicationsChanging the administration time of once daily blood pressure lowering medications, one at a time as tolerated, from morning to bedtime. | Other | Bedtime Antihypertensive Medications |
Primary outcome
Composite of Major Adverse Cardiovascular Events
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Composite of all-cause death and hospital admission or emergency room visit for acute coronary syndrome / myocardial infarction, heart failure, or stroke - as recorded in governmental health claims databases
12 secondary outcomes
All Cause Mortality
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Acute Coronary Syndrome / Myocardial Infarction
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Stroke
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Hospitalization for Congestive Heart Failure
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
All Cause Unplanned Hospitalization
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Non-vertebral Fracture
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Number of Patients with a Fall in the Last 30 days
Time frame: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with "Deteriorated Cognition Relative to Status 90 Days Prior"
Time frame: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with Urinary Incontinence
Time frame: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Number of Patients with Partial or Full Thickness Decubitus Skin Ulceration ("Bed Sores")
Time frame: 4.5 Months (Average - will occur within a 3 to 6 month post randomization window)
Acute Care Costs
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Total Cost of Care
Time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 40354050Garrison SR, Youngson ERE, Perry DA, Campbell FN, Korownyk CS, Green LA, Kolber MR, Kirkwood JEM, Allan GM, Kraut RY, McAlister FA, Hill MD, Bakal JA. Bedtime vs Morning Antihypertensive Medications in Frail Older Adults: The BedMed-Frail Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e2513812. doi: 10.1001/jamanetworkopen.2025.13812.
- Derived from this study: PubMed 37527898Garrison SR, Youngson E, Perry DA, Campbell FN, Kolber MR, Korownyk C, Allan GM, Green L, Bakal J. Bedtime versus morning use of antihypertensives in frail continuing care residents (BedMed-Frail): protocol for a prospective, randomised, open-label, blinded end-point pragmatic trial. BMJ Open. 2023 Aug 1;13(8):e074777. doi: 10.1136/bmjopen-2023-074777.
- Individual participant dataSharing planned: Yes. Although we hope to make a de-identified participant-level version of our final analytic dataset publicly available on our website (www.PragmaticTrials.ca), and will request to do so, this requires the permission of Alberta Health Services, who must weigh the privacy concerns.
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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.
Scott R Garrison, MD, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime administration of the participant's pre-existing antihypertensive medications in people with Hypertension and Dementia, run by University of Alberta at 1 site in Canada.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of Major Adverse Cardiovascular Events (time frame: 3 years (Estimate Only - study continues until 368 participants have experienced primary outcome events)). 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 NCT04054648, which also lists 2 linked publications.
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 27 Aug 2024.