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Monoclonal Antibodies
Cholesterol-Lowering Medication for Heart Attack (EVOLVE-MI Trial)
Phase 4
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age greater than or equal to 18 years
Hospitalized for primary reason of NSTEMI or STEMI due to presumed atherosclerotic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to end of study (approximately 3.5 years)
Awards & highlights
EVOLVE-MI Trial Summary
This trialstudies if a cholesterol-lowering medication can reduce heart attack, stroke and death in people hospitalized for a heart attack.
Who is the study for?
This trial is for adults over 18 who are hospitalized due to a heart attack (NSTEMI or STEMI) presumed to be caused by plaque buildup in the arteries. It's not open to those needing intensive support like pumps or drugs for blood pressure at screening, or if their heart damage isn't due to artery issues.Check my eligibility
What is being tested?
The EVOLVE-MI study tests whether giving Evolocumab with standard cholesterol management right after a heart attack is better than just routine care alone. The goal is to see if this can reduce further heart attacks, strokes, surgeries on arteries, and deaths.See study design
What are the potential side effects?
Evolocumab may cause reactions where it's injected, flu-like symptoms, back pain, high blood pressure episodes, and allergic reactions. Side effects vary from person to person.
EVOLVE-MI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I was hospitalized for a heart attack caused by blocked arteries.
EVOLVE-MI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to end of study (approximately 3.5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to end of study (approximately 3.5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death
Secondary outcome measures
Percentage Change From Baseline in LDL-C
Time to All-Cause Death
Time to Cardiovascular Death
+6 moreEVOLVE-MI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Evolocumab + Routine Lipid ManagementExperimental Treatment2 Interventions
Participants will receive open-label evolocumab every 2 weeks (Q2W) plus routine lipid management.
Group II: Routine Lipid ManagementActive Control1 Intervention
Participants will receive routine lipid management per standard of care (SoC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evolocumab
2011
Completed Phase 4
~13010
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,371 Previous Clinical Trials
1,372,106 Total Patients Enrolled
Colorado Prevention CenterOTHER
12 Previous Clinical Trials
16,634 Total Patients Enrolled
MDStudy DirectorAmgen
914 Previous Clinical Trials
918,579 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have heart damage not caused by blocked arteries, like from an infection or uncontrolled high blood pressure.I need machines or drugs to help my heart and blood pressure work.I was hospitalized for a heart attack caused by blocked arteries.
Research Study Groups:
This trial has the following groups:- Group 1: Evolocumab + Routine Lipid Management
- Group 2: Routine Lipid Management
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Heart Attack Patient Testimony for trial: Trial Name: NCT05284747 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to participate in this medical exploration?
"This medical study is open to a cohort of 4000 stroke patients aged between 18 and 99. In addition, they must have been recently hospitalized for an NSTEMI or STEMI stemming from atherosclerotic disease in order to qualify."
Answered by AI
Could you elucidate the potential risks of Evolocumab combined with Routine Lipid Management?
"A score of 3 is assigned to Evolocumab + Routine Lipid Management, due to its status as a Phase 4 medication--indicating that it has been approved."
Answered by AI
Does this research accept participants of 40 years or older?
"As per the terms of this medical experiment, participants must be between 18 and 99 years old to qualify."
Answered by AI
Are there any slots remaining for potential participants in this experiment?
"According to the official clinicaltrials.gov page, this experiment is still in need of volunteers and has been accepting applications since October 26th 2022. The posting was most recently updated on November 21st 2022."
Answered by AI
How many volunteers have consented to participate in this experiment?
"Affirmative. The information available on clinicaltrials.gov elucidates that this medical research is currently open for recruitment, having been initially posted on October 26th 2022 and updated most recently on November 21st 2022. 4000 participants are being sought out from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Kansas
What site did they apply to?
Ascension Saint Vincent Heart Center
Midwest Heart and Vascular Specialists
Richmond University Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
Would like to maintain a low lipid profile as both my parents suffered strokes.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long with the trial last?
PatientReceived no prior treatments
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