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Electronic Alerts for High Cholesterol (LDL-ALERT Trial)
N/A
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
LDL-ALERT Trial Summary
This trial is focused on the feasibility of implementing an electronic alert system to notify patients and doctors of high LDL-C values. 400 patients will be randomly selected to either receive notifications or not.
Who is the study for?
This trial is for U.S. adults over 18 with cardiovascular issues like heart disease or stroke, who are on statins but not other specific cholesterol drugs, and have LDL (bad) cholesterol levels above 80 mg/dL within the last year.Check my eligibility
What is being tested?
The study tests if an electronic alert system helps manage LDL cholesterol better in patients. It randomly assigns hospitalized and outpatient participants to either receive alerts or no alerts about their LDL levels.See study design
What are the potential side effects?
Since this trial involves an alert-based decision support system rather than a medication, there are no direct side effects from interventions like you would expect with drug trials.
LDL-ALERT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
frequency of prescription of appropriate LDL-lowering therapy
Secondary outcome measures
Change in LDL-C level at next follow-up laboratory test
LDL-ALERT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AlertExperimental Treatment1 Intervention
an on-screen electronic alert will prompt the responsible inpatient provider (inpatient cohort) or the cardiologist of record for the clinic visit (outpatient cohort) as follows:
All patients whose LDL-C is not less than 70 mg/dL and not taking a maximally tolerated statin dose will prompt a recommendation for statin intensification
All patients whose LDL-C is within 20% of 70 mg/dL and who are on a maximally tolerated statin dose but not on ezetimibe or PCSK9 inhibitor will receive a prompt for adding ezetimibe
All patients whose LDL-C is greater than 20% of goal, and on a maximally tolerated statin (±ezetimibe) but not on PCSK9 inhibitor will receive a prompt for initiating PCSK9 inhibitor
Group II: No AlertActive Control1 Intervention
No notification will be issues
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alert
2013
N/A
~85360
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,477 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your most recent cholesterol test showed LDL-C levels higher than 80 mg/dL in the past year.I am taking a statin but not ezetimibe or PCSK9 inhibitors.I am over 18 and have a history of heart or artery disease.I am currently on PCSK9 inhibitor therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Alert
- Group 2: No Alert
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently receiving treatment in this investigation?
"Affirmative. Clinicaltrials.gov's information indicates that this trial is currently searching for participants, with the initial posting dating back to October 8th 2021 and updated on the 21st of same month. The study requires a total of 400 patients from 1 site locations."
Answered by AI
Has recruitment begun for this experiment?
"True, the information accessible on clinicaltrials.gov reveals that this trial is still open to participants and has been since October 8th 2021. The latest update was made on October 21st 2021 and they are currently recruiting 400 patients from 1 site."
Answered by AI
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