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Tests treatment safety and results for Acute Coronary Syndrome
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?
Inclisiran is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute coronary syndrome.
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 purpose of this trial is to learn about the effects of inclisiran in people with serious heart conditions (acute coronary syndromes), when this treatment is started early after hospital admission. To do this, researchers will test the effects of inclisiran compared to placebo, when given with standard treatment.
- 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
- Participant eligible for inclusion in this study must meet all the following criteria: At Screening:
- 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).
You likely can't join if
- Participant meeting any of the following criteria is not eligible for inclusion in this study. Only for Japan: For exclusion criteria 6, investigator...
- Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours...
- Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms...
- Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)
- Cardiogenic shock or mechanical complication of myocardial infarction
- New York Heart Association (NYHA) class IV heart failure
See the full eligibility criteria
- Participant eligible for inclusion in this study must meet all the following criteria: At Screening:
- 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 value at the Screening visit measured by the local lab of:
- 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 ≥100 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or
- LDL-C ≥125 mg/dL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants). At Randomization:
- 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.
- Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization:
- Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of \<90 mmHg due to cardiac failure with associated symptoms requiring inotropes
- Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter)
- 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.
- 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's taking place
- Clayton, Victoria, Australia
- 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
- Chambray-lès-Tours, France
- Montpellier, France
- Nantes, France
- Pessac, France
- Poitiers, France
+ 38 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clayton, Victoria, Australia; Montreal, Quebec, Canada; Québec, Quebec, Canada; Beijing, China, China; Guangzhou, Guangdong, China; Luoyang, Henan, China and 52 more location(s). 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.