Actively Recruiting
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
Led by Novartis Pharmaceuticals · Updated on 2026-04-27
300
Participants Needed
58
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before participation
- Male or female, 18 years or older
- Able to understand study requirements and follow procedures
- Hospitalized for an acute coronary syndrome (STEMI or NSTEMI)
- Receiving treatment for the qualifying ACS event by medical therapy or percutaneous coronary revascularization
- Had a successful PCI for the qualifying event if PCI was needed
- LDL-C value at screening meeting specified thresholds based on previous statin treatment
- Baseline fasting LDL-C 6070 mg/dL at randomization
- Randomization within 7 days of hospital admission and before or at discharge
You will not qualify if you...
- Clinically unstable during hospitalization within 24 hours prior to randomization (including hypotension, arrhythmic events, cardiogenic shock, class IV heart failure, LVEF <20%, uncontrolled severe hypertension)
- Undergoing or scheduled for coronary artery bypass graft surgery for the qualifying event
- Active liver disease or elevated liver enzymes beyond specified levels at screening
- Renal insufficiency with eGFR <30 mL/min/1.73m2 at screening
- Fasting triglycerides >400 mg/dL at randomization
- Expected to reach LDL-C target <55 mg/dL after 4 weeks of statin treatment only
- Secondary hypercholesterolemia or homozygous familial hypercholesterolemia
- On apheresis at screening
- Ongoing or history of myopathy at screening
- Creatine kinase (CK) values 605x upper limit normal at screening confirmed by repeat test
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
2
Novartis Investigative Site
Montreal, Quebec, Canada, H1T 1C8
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3
Novartis Investigative Site
Beijing, China, China, 100037
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4
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
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5
Novartis Investigative Site
Luoyang, Henan, China, 471002
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6
Novartis Investigative Site
Xuzhou, Jiangsu, China, 221003
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7
Novartis Investigative Site
Nanchang, Jiangxi, China, 330009
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8
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325000
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9
Novartis Investigative Site
Beijing, China, 100191
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10
Novartis Investigative Site
Beijing, China, 100730
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11
Novartis Investigative Site
Guangzhou, China, 510260
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12
Novartis Investigative Site
Guangzhou, China, 510280
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13
Novartis Investigative Site
Jining, China, 272011
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14
Novartis Investigative Site
Shanghai, China, 200032
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15
Novartis Investigative Site
Shanghai, China, 200120
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16
Novartis Investigative Site
Tianjin, China, 300052
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17
Novartis Investigative Site
Chambray-lès-Tours, France, 37170
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18
Novartis Investigative Site
Montpellier, France, 34295
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19
Novartis Investigative Site
Nantes, France, 44093
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20
Novartis Investigative Site
Pessac, France, 33604
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21
Novartis Investigative Site
Poitiers, France, 86021
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22
Novartis Investigative Site
Leipzig, Saxony, Germany, 04289
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23
Novartis Investigative Site
Coburg, Germany, 96450
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24
Novartis Investigative Site
Essen, Germany, 45147
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25
Novartis Investigative Site
Hennigsdorf, Germany, 16761
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26
Novartis Investigative Site
Kiel, Germany, 24105
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27
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong, 999077
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28
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
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29
Novartis Investigative Site
Pécs, Baranya, Hungary, 7623
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30
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, Hungary, 4032
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31
Novartis Investigative Site
Budapest, Hungary, 1134
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32
Novartis Investigative Site
Budapest, Hungary, H-1083
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33
Novartis Investigative Site
Miskolc, Hungary, 3526
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34
Novartis Investigative Site
Belagavi, Karnataka, India, 590010
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35
Novartis Investigative Site
Nashik, Maharashtra, India, 422005
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36
Novartis Investigative Site
Bikaner, Rajasthan, India, 334003
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37
Novartis Investigative Site
Chikushino-shi, Fukuka, Japan, 818-8516
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38
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 8028555
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39
Novartis Investigative Site
Kamakura, Kanagawa, Japan, 247-8533
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40
Novartis Investigative Site
Sagamihara, Kanagawa, Japan, 252-0375
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41
Novartis Investigative Site
Bunkyo Ku, Tokyo, Japan, 1138431
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42
Novartis Investigative Site
Gdansk, Poland, 80-214
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43
Novartis Investigative Site
Krakow, Poland, 31 202
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44
Novartis Investigative Site
Opole, Poland, 45-401
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45
Novartis Investigative Site
Seoul, Seoul, South Korea, 06351
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46
Novartis Investigative Site
Seoul, South Korea, 07804
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47
Novartis Investigative Site
Santiago Compostela, A Coruna, Spain, 15706
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48
Novartis Investigative Site
Huelva, Andalusia, Spain, 21005
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49
Novartis Investigative Site
El Palmar, Murcia, Spain, 30120
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50
Novartis Investigative Site
Las Palmas GC, Spain, 35010
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51
Novartis Investigative Site
Madrid, Spain, 28034
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52
Novartis Investigative Site
Madrid, Spain, 28046
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53
Novartis Investigative Site
Salamanca, Spain, 37007
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54
Novartis Investigative Site
Seville, Spain, 41013
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55
Novartis Investigative Site
Valencia, Spain, 46010
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56
Novartis Investigative Site
Bern, Switzerland, 3010
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57
Novartis Investigative Site
Geneva, Switzerland, 1211
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58
Novartis Investigative Site
Lucerne, Switzerland, 6000
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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