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New treatment option for Atherosclerotic Cardiovascular Disease
Official title The Prevent Coronary Artery Disease Trial
ClinicalTrials.gov ID: NCT06494501
What this study is testing
What is Inclisiran?
Inclisiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for atherosclerotic cardiovascular disease.
Also referred to as Leqvio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evidence to support primary prevention strategies in adults aged 30-50 years. The researchers have designed a randomized controlled trial to evaluate whether strict control of CVRF in young adults without known cardiovascular disease, will reduce the progression of total atherosclerosis burden, a surrogate endpoint for symptomatic cardiovascular disease, compared with usual care.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 50
You may be able to join if
- Male or female people between 30 to 50 years of age.
- No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease.
- Serum LDL-C \> 1.8 mmol/l (70 mg/dl).
- Presence of subclinical atherosclerosis as assessed by 3DVUS or by the presence of coronary artery calcium (defined as coronary artery calcium score...
- Family history of premature atherosclerotic CVD
You likely can't join if
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or...
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with...
- Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception...
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years.
- History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three...
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in ALT...
See the full eligibility criteria
- Male or female people between 30 to 50 years of age.
- No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease.
- Serum LDL-C \> 1.8 mmol/l (70 mg/dl).
- Presence of subclinical atherosclerosis as assessed by 3DVUS or by the presence of coronary artery calcium (defined as coronary artery calcium score ≥25), independent of risk calculators; and/or high lifetime risk...
- Family history of premature atherosclerotic CVD
- Persistently elevated LDL-C ≥ 160 mg/dl
- Chronic kidney disease
- Metabolic syndrome
- Conditions specific to women (e.g. preeclampsia, premature menopause)
- Inflammatory diseases (especially rheumatoid arthritis, psoriasis, HIV)
- Ethnicity (e.g., South Asian ancestry)
- Persistently elevated triglycerides (≥175 mg/dl)
- Hs-CRP ≥2 mg/L
- Lp(a) levels \>50 mg/dl
- apoB ≥130 mg/dl
- Ankle-brachial index \<0.9
- Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator's [or...
- An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception (failure rate less than 1% per year) (e.g. combined oral...
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years.
- History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization
- Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in ALT, aspartate aminotransferase (AST), \>3x the ULN, or total bilirubin \>2x ULN...
- Known contraindications to anti-lipid therapy
- Known history of alcohol and/or drug abuse within the last 5 years.
- Treatment with other investigational products or devices within 30 days or five half- lives of the screening visit, whichever is longer.
- Planned use of other investigational products or devices during the course of the study.
- Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
- people who are unable to communicate or to cooperate with the investigator.
- Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including people whose cooperation is doubtful due to drug abuse or...
- Unlikely to comply with the protocol requirements, instructions, and study- related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
- Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study.
- Persons directly involved in the conduct of the study.
- Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.
- History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.