Status:
COMPLETED
Management of LDL-cholesterol With Inclisiran + Usual Care Compared to Usual Care Alone in Participants With a Recent Acute Coronary Syndrome
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acu...
Detailed Description
This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual ...
Eligibility Criteria
Inclusion
- Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
- Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
- Fasting triglycerides \<4.52 mmol/L (\<400 mg/dL) at screening
- Calculated glomerular filtration rate \>20 mL/min by estimated glomerular filtration rate (eGFR)
- Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose
Exclusion
- New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction \<25%.
- Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
- Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 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.
- Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
- Recurrent ACS event within 2 weeks prior to randomization.
- Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.
Key Trial Info
Start Date :
June 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04873934
Start Date
June 24 2021
End Date
August 7 2024
Last Update
October 16 2025
Active Locations (88)
Enter a location and click search to find clinical trials sorted by distance.
1
Northeast Arkansas Baptist Clinic
Jonesboro, Arkansas, United States, 72401
2
Central Cardiology Medical Center
Bakersfield, California, United States, 93308
3
The Heart Group Cardiovascular Associates Inc
Fresno, California, United States, 93720
4
Mission Heritage Medical Group
Mission Viejo, California, United States, 92691