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Antisense Oligonucleotide

Olpasiran for Cardiovascular Disease

Phase 3
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of ASCVD as evidenced by history of either: Myocardial infarction (presumed type 1 event due to plaque rupture/erosion) and/or Coronary revascularization with percutaneous coronary intervention AND at least 1 additional risk factor.
Age 18 to ≤ 85 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial tests the effect of a drug, olpasiran, to reduce risk of death, heart attack, and coronary revascularization in people with atherosclerotic cardiovascular disease and high Lipoprotein(a).

Who is the study for?
This trial is for adults aged 18 to 85 with a history of heart-related issues like myocardial infarction or stent procedures, plus one additional risk factor. They must have high levels of Lipoprotein(a) in their blood. People with severe kidney problems, certain liver conditions, bleeding disorders, planned heart surgeries, severe heart failure, or those who've had specific RNA treatments can't participate.Check my eligibility
What is being tested?
The study aims to see if Olpasiran can reduce the risk of death from coronary disease and other serious heart events compared to a placebo in people with cardiovascular disease and high Lipoprotein(a). Participants are randomly assigned to receive either Olpasiran or a placebo.See study design
What are the potential side effects?
While the side effects for Olpasiran aren't detailed here, similar medications may cause injection site reactions, liver enzyme changes, flu-like symptoms and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had a heart attack or surgery to open my heart's arteries and have at least one other heart risk factor.
Select...
I am between 18 and 85 years old.
Select...
I have had a heart attack or stent placement and have at least one other risk factor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to CHD death, myocardial infarction, or urgent coronary revascularization, whichever occurs first
Secondary outcome measures
Lipoproteins
Time to CHD death
Time to CHD death or myocardial infarction, whichever occurs first
+8 more

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04270760
11%
Headache
9%
Injection site pain
7%
Myalgia
7%
COVID-19
7%
Injection site erythema
7%
Non-cardiac chest pain
7%
Immunisation reaction
5%
Injection site pruritus
5%
Oedema peripheral
5%
Pain in extremity
5%
Nausea
4%
Type 2 diabetes mellitus
4%
Constipation
4%
Arthralgia
4%
Sinusitis
4%
Abdominal pain
4%
Hypertension
4%
Gastroenteritis
4%
Fatigue
2%
Atrial fibrillation
2%
Injection site reaction
2%
Diverticulitis
2%
Seizure
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
2%
Nasopharyngitis
2%
Dizziness
2%
Anaemia
2%
Upper respiratory tract infection
2%
Campylobacter infection
2%
Urticaria
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 5; Treatment Period: Placebo Q12W
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
Group 5; Extended Safety Follow-up: Placebo Q12W

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OlpasiranExperimental Treatment1 Intervention
Olpasiran will be administered by subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Placebo will be administered by subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,370,391 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
916,834 Total Patients Enrolled

Media Library

Olpasiran (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT05581303 — Phase 3
Cardiovascular Disease Research Study Groups: Placebo, Olpasiran
Cardiovascular Disease Clinical Trial 2023: Olpasiran Highlights & Side Effects. Trial Name: NCT05581303 — Phase 3
Olpasiran (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05581303 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative accepting participants who are over the age of 40?

"The requisite age range for participants of this experiment is between 18-85. Subsequently, there are 29 trials specifically meant to target minors and 449 study opportunities targeting seniors."

Answered by AI

Is this clinical experiment actively recruiting participants?

"According to clinicaltrials.gov, this trial is open for enrolment with the initial listing on December 14th 2022 and the most recent update occurring on January 9th 2023."

Answered by AI

Has Olpasiran received the endorsement of the FDA?

"Given the success of its Phase 3 trials, our experts at Power have rated Olpasiran's safety a 3, signifying that there is ample proof of both efficacy and precautionary measures."

Answered by AI

What type of individuals are ideal for participating in this experiment?

"This clinical trial seeks 6000 individuals who have atherosclerotic cardiovascular disease, with an age range between 18 to 85 years old. In addition, potential candidates must also possess a Lp(a) level of ≥ 200 nmol/L during the screening process."

Answered by AI

At what number of venues is this scientific inquiry taking place?

"Currently, the trial is operational in 46 distinct sites located across Phoenix, Beverly Hills and Toluca Lake as well as other cities. For those wishing to participate it is encouraged that they select a location closest to them so that travelling costs are kept low."

Answered by AI

To what extent is the subject pool being utilized for this research?

"Amgen, the trial's sponsor, must recruit 6,000 suitable patients to run this experiment. This will be accomplished through Elite Clinical Studies LLC in Phoenix and Westside Medical Associates of Los Angeles in Beverly Hills."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Indiana
What site did they apply to?
Nsc Research
Advocate Lutheran General Hospital
NSC Research
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
2

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial
2022. "Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction (OCEAN(a)) - Outcomes Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05581303.
All > Atherosclerosis > Fargo
~4865 spots leftby Dec 2026
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