NCT07102628 Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
| NCT ID | NCT07102628 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-10-03 |
| Primary Completion | 2027-02-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2025-10-03 with a primary completion date of 2027-02-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Participant eligible for inclusion in this study must meet all the following criteria: At Screening: 1. Signed informed consent must be obtained prior to participation in the study. 2. Males and females, ≥18 years of age at the time of providing written informed consent. 3. Ability to understand study's requirements and provide informed consent and comply with all required study procedures. 4. Hospitalization for a ACS event (STEMI or NSTEMI). 5. Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization. 6. Had a successful PCI (with or without stent) for the qualifying event if a PCI was required. 7. 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 screening or * 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: 8. The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization. 9. Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge. Exclusion Criteria: 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. 1. 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. 2. Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event. 3. 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 \>3x ULN, or total bilirubin elevation \>2x ULN (except participant with Gilbert's syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI). Eligibility will be based on Investigator's judgement for participant who will be randomized. 4. Renal insufficiency (eGFR \<30 mL/min/1.73m2) at the Screening visit. 5. Fasting triglycerides value \>400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit. 6. 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. 7. Secondary hypercholesterolemia (based on medical history). 8. Homozygous familial hypercholesterolemia (based on medical history). 9. Participant on apheresis at the Screening visit. 10. Ongoing or medical history of myopathy at the Screening visit. 11. 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 will be based on Investigator's judgement for participant who will be randomized (who will be switched to or initiated on the protocol-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07102628 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07102628 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07102628 currently recruiting?
Yes, NCT07102628 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07102628 trial being conducted?
This trial is being conducted at Clayton, Australia, Montreal, Canada, Beijing, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT07102628 clinical trial?
NCT07102628 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 300 participants.