| NCT ID | NCT06501443 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Hypercholesterolaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 520 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2026-11-27 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 520 participants in total. It began in 2025-02-11 with a primary completion date of 2026-11-27.
⚠ 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
This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.
Eligibility Criteria
Inclusion Criteria: * Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke. * Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization: * Was not in cardiogenic shock. * Did not required invasive hemodynamic, inotropic or vasopressor support. * Participants are required to be eligible for receiving inclisiran in accordance to approved local label. * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization. Exclusion Criteria: * Currently on PCSK9i therapy (within last 3 months) * Current participation in another clinical study with another study drug * Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit * Pregnant or nursing (lactating) women * Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06501443 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hypercholesterolaemia. 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 NCT06501443 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06501443 currently recruiting?
Yes, NCT06501443 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT06501443 trial being conducted?
This trial is being conducted at Corrientes, Argentina, Salvador, Brazil, Belo Horizonte, Brazil, Belo Horizonte, Brazil and 7 additional locations.
Who is sponsoring the NCT06501443 clinical trial?
NCT06501443 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 520 participants.