Acute Coronary Syndrome study: Inclisiran
Official title Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
ClinicalTrials.gov ID: NCT07102628
What this study is testing
What is Inclisiran?
an investigational injectable medicine being studied as a potential treatment for acute coronary syndrome is designed to silence the PCSK9 gene in the liver, which can lower LDL‑cholesterol levels
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
- The study aims to learn how inclisiran affects patients with serious heart conditions when started soon after hospital admission, compared to a placebo.
- Who it's for
- Adults who have been admitted to the hospital with an acute coronary syndrome.
- What's involved
- Participants will receive either inclisiran or a placebo along with their usual heart‑care treatment.
- Time commitment
- The study lasts for the duration of the hospital stay and includes follow‑up visits after discharge.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed informed consent must be obtained prior to participation in the study.
- Males and females, ≥18 years of age at the time of providing written informed consent.
- Ability to understand study's requirements and provide informed consent and comply with all required study procedures.
- Hospitalization for a ACS event (STEMI or NSTEMI).
- Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary...
You likely can't join if
- Participant meeting any of the following criteria is not eligible for inclusion in this study.
- Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms...
- Sustained arrhythmic events such as: ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) not resolved before randomization
- Cardiogenic shock or mechanical complication of myocardial infarction
- New York Heart Association (NYHA) class IV heart failure
- Left ventricular ejection fraction \<20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive...
See the full eligibility criteria
- Signed informed consent must be obtained prior to participation in the study.
- Males and females, ≥18 years of age at the time of providing written informed consent.
- Ability to understand study's requirements and provide informed consent and comply with all required study procedures.
- Hospitalization for a ACS event (STEMI or NSTEMI).
- Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.
- Had a successful PCI (with or without stent) for the qualifying event if a PCI was required.
- LDL-C ≥70 mg/dL in participant previously treated with high-intensity statin (atorvastatin ≥40 mg/day or rosuvastatin ≥20 mg/day) or equivalent as per national guidelines and local regulation for at least 4 weeks before...
- LDL-C ≥80 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or
- The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization.
- Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge.
- Participant meeting any of the following criteria is not eligible for inclusion in this study. Only for Japan: For exclusion criteria 6, investigator judgment should be documented in the source data document.
- Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms requiring inotropes
- Sustained arrhythmic events such as: ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) not resolved before randomization
- Cardiogenic shock or mechanical complication of myocardial infarction
- New York Heart Association (NYHA) class IV heart failure
- Left ventricular ejection fraction \<20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities)
- Uncontrolled severe hypertension: systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg prior to randomization despite antihypertensive therapy.
- Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.
- Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation \>3x ULN or aspartate aminotransferase (AST) elevation...
- Renal insufficiency (eGFR \<30 mL/min/1.73m2) at the Screening visit.
- Fasting triglycerides value \>400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit.
- Participant, who based on the Investigator's judgement, could reach the LDL-C target value of \<55 mg/dL after 4 weeks on statin treatment only.
- Secondary hypercholesterolemia (based on medical history).
- Homozygous familial hypercholesterolemia (based on medical history).
- Participant on apheresis at the Screening visit or for whom an apheresis is planned during study (from Day 1 to EOS).
- Ongoing or medical history of myopathy at the Screening visit.
- CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab) , in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI) eligibility...
The study team makes the final eligibility decision.
Where it is enrolling
- Garran, Australian Capital Territory, Australia
- Clayton, Victoria, Australia
- Edmonton, Alberta, Canada
- Hamilton, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Beijing, China, China
- Guangzhou, Guangdong, China
- Luoyang, Henan, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Wenzhou, Zhejiang, China
- Beijing, China
- Fuzhou, China
- Guangzhou, China
- Jining, China
- Shanghai, China
- Tianjin, China
- Hong Kong, Hong Kong, Hong Kong
- Hong Kong, Hong Kong
+ 4 more site(s).
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, but 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Garran, Australian Capital Territory, Australia; Clayton, Victoria, Australia; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Montreal, Quebec, Canada; Québec, Quebec, Canada and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.