Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol (ORION-10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399370
Recruitment Status : Completed
First Posted : January 16, 2018
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions ASCVD
Elevated Cholesterol
Interventions Drug: Inclisiran Sodium
Drug: Placebo
Enrollment 1561
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Inclisiran Saline Solution
Hide Arm/Group Description

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Period Title: Overall Study
Started 781 780
Completed 721 694
Not Completed 60 86
Arm/Group Title Inclisiran Placebo Total
Hide Arm/Group Description

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

Total of all reporting groups
Overall Number of Baseline Participants 781 780 1561
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 781 participants 780 participants 1561 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
297
  38.0%
333
  42.7%
630
  40.4%
>=65 years
484
  62.0%
447
  57.3%
931
  59.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 781 participants 780 participants 1561 participants
66.4  (8.90) 65.7  (8.89) 66.0  (8.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 781 participants 780 participants 1561 participants
Female
246
  31.5%
232
  29.7%
478
  30.6%
Male
535
  68.5%
548
  70.3%
1083
  69.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 781 participants 780 participants 1561 participants
American Indian or Alaska Native
2
   0.3%
4
   0.5%
6
   0.4%
Asian
9
   1.2%
1
   0.1%
10
   0.6%
Native Hawaiian or Other Pacific Islander
7
   0.9%
3
   0.4%
10
   0.6%
Black or African American
110
  14.1%
87
  11.2%
197
  12.6%
White
653
  83.6%
685
  87.8%
1338
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 781 participants 780 participants 1561 participants
781 780 1561
1.Primary Outcome
Title Percentage Change in LDL-C From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-56.34
(-58.35 to -54.34)
1.30
(-1.24 to 3.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments LS Mean Difference (95% CI) from Placebo
Statistical Test of Hypothesis P-Value <.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -57.64
Confidence Interval (2-Sided) 95%
-60.86 to -54.43
Estimation Comments Represents the least squares mean difference from Placebo
2.Primary Outcome
Title Time-adjusted Percentage Change in LDL-C Levels From Baseline After Day 90 and up to Day 540
Hide Description Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Time Frame Baseline, Day 90 to Day 540
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 790
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-51.27
(-53.00 to -49.54)
2.51
(0.77 to 4.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments LS Mean Difference (95% CI) from Placebo
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -53.78
Confidence Interval (2-Sided) 95%
-56.23 to -51.33
Estimation Comments Represents the least squares mean difference from Placebo
3.Secondary Outcome
Title Absolute Change in LDL-C From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-56.18
(-58.47 to -53.90)
-2.06
(-4.36 to 0.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments LS Mean Difference (95% CI) from Placebo
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -54.12
Confidence Interval (2-Sided) 95%
-57.37 to -50.88
Estimation Comments Represents the least squares mean difference from Placebo
4.Secondary Outcome
Title Time-adjusted Absolute Change in LDL-C From Baseline After Day 90 and up to Day 540
Hide Description Assessments performed at Baseline, Day 90, Day 540, time-adjusted percent change at Day 540 reported
Time Frame Baseline, Day 90 to Day 540
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: mg/dL
-53.66
(-55.41 to -51.92)
-0.39
(-2.14 to 1.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -53.28
Confidence Interval (2-Sided) 95%
-55.75 to -50.80
Estimation Comments Represents the least squares mean difference from Placebo
5.Secondary Outcome
Title Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-69.78
(-73.88 to -65.67)
13.52
(9.28 to 17.77)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -83.80
Confidence Interval (2-Sided) 95%
-89.25 to -77.34
Estimation Comments Represents the least squares mean difference from Placebo
6.Secondary Outcome
Title Percentage Change in Total Cholesterol From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 781
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-33.56
(-35.09 to -32.03)
-0.42
(-1.95 to 1.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -33.13
Confidence Interval (2-Sided) 95%
-35.30 to -30.97
Estimation Comments Represents the least squares mean difference from Placebo
7.Secondary Outcome
Title Percentage Change in Apolipoprotein B (ApoB) From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-44.81
(-46.52 to -43.10)
-1.72
(-3.46 to 0.02)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -43.09
Confidence Interval (2-Sided) 95%
-45.50 to -40.67
Estimation Comments Represents the least squares mean difference from Placebo
8.Secondary Outcome
Title Percentage Change in Non-HDL-C From Baseline to Day 510
Hide Description [Not Specified]
Time Frame Baseline, Day 510
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Inclisiran Placebo
Hide Arm/Group Description:
Inclisiran sodium 300 milligrams (mg) (equivalent to 284 mg inclisiran) administered as a subcutaneous injection on Day 1, Day 90, and then every 6 months.
Placebo administered as a subcutaneous injection of sterile saline solution (0.9% sodium chloride in water for injection) on Day 1, Day 90, and then every 6 months.
Overall Number of Participants Analyzed 781 780
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-47.41
(-49.44 to -45.38)
-0.05
(-2.08 to 1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Inclisiran, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments The a priori threshold for statistical significance was <0.05
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -47.36
Confidence Interval (2-Sided) 95%
-50.25 to -44.47
Estimation Comments Represents the least squares mean difference from Placebo
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Inclisiran Saline Solution
Hide Arm/Group Description

Inclisiran sodium 300 milligrams (mg) will be administered as a SC injection on Day 1, Day 90, then every 6 months.

Inclisiran Sodium: Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.

Placebo will be administered as a SC injection of saline solution on Day 1, Day 90, then every 6 months.

Placebo: Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).

All-Cause Mortality
Inclisiran Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   12/781 (1.54%)   11/778 (1.41%) 
Hide Serious Adverse Events
Inclisiran Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   175/781 (22.41%)   205/778 (26.35%) 
Blood and lymphatic system disorders     
Anaemia  1  3/781 (0.38%)  1/778 (0.13%) 
Haemorrhagic anaemia  1  2/781 (0.26%)  0/778 (0.00%) 
Iron deficiency anaemia  1  0/781 (0.00%)  1/778 (0.13%) 
Leukocytosis  1  0/781 (0.00%)  1/778 (0.13%) 
Leukopenia  1  1/781 (0.13%)  0/778 (0.00%) 
Thrombocytopenia  1  1/781 (0.13%)  0/778 (0.00%) 
Cardiac disorders     
Acute coronary syndrome  1  0/781 (0.00%)  2/778 (0.26%) 
Acute myocardial infarction  1  14/781 (1.79%)  12/778 (1.54%) 
Angina pectoris  1  6/781 (0.77%)  7/778 (0.90%) 
Angina unstable  1  4/781 (0.51%)  10/778 (1.29%) 
Arteriosclerosis coronary artery  1  0/781 (0.00%)  1/778 (0.13%) 
Atrial fibrillation  1  10/781 (1.28%)  8/778 (1.03%) 
Atrial flutter  1  0/781 (0.00%)  1/778 (0.13%) 
Atrioventricular block  1  2/781 (0.26%)  0/778 (0.00%) 
Atrioventricular block complete  1  1/781 (0.13%)  0/778 (0.00%) 
Atrioventricular block second degree  1  0/781 (0.00%)  1/778 (0.13%) 
Bradycardia  1  1/781 (0.13%)  2/778 (0.26%) 
Cardiac arrest  1  1/781 (0.13%)  1/778 (0.13%) 
Cardiac failure  1  0/781 (0.00%)  1/778 (0.13%) 
Cardiac failure acute  1  1/781 (0.13%)  1/778 (0.13%) 
Cardiac failure congestive  1  7/781 (0.90%)  20/778 (2.57%) 
Cardio-respiratory arrest  1  1/781 (0.13%)  0/778 (0.00%) 
Cardiomyopathy  1  2/781 (0.26%)  0/778 (0.00%) 
Coronary artery disease  1  15/781 (1.92%)  22/778 (2.83%) 
Coronary artery occlusion  1  1/781 (0.13%)  2/778 (0.26%) 
Ischaemic cardiomyopathy  1  1/781 (0.13%)  0/778 (0.00%) 
Left ventricular failure  1  3/781 (0.38%)  1/778 (0.13%) 
Mitral valve incompetence  1  0/781 (0.00%)  3/778 (0.39%) 
Myocardial infarction  1  6/781 (0.77%)  6/778 (0.77%) 
Nodal arrythmia  1  0/781 (0.00%)  1/778 (0.13%) 
Palpitations  1  0/781 (0.00%)  1/778 (0.13%) 
Pericardial effusion  1  0/781 (0.00%)  1/778 (0.13%) 
Pericarditis  1  0/781 (0.00%)  2/778 (0.26%) 
Sinus node dysfunction  1  0/781 (0.00%)  2/778 (0.26%) 
Supraventricular tachycardia  1  0/781 (0.00%)  2/778 (0.26%) 
Tachycardia  1  0/781 (0.00%)  1/778 (0.13%) 
Ventricular extrasystoles  1  1/781 (0.13%)  0/778 (0.00%) 
Ventricular fibrillation  1  0/781 (0.00%)  2/778 (0.26%) 
Ventricular tachyarrhythmia  1  1/781 (0.13%)  0/778 (0.00%) 
Ventricular tachycardia  1  2/781 (0.26%)  4/778 (0.51%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  0/781 (0.00%)  1/778 (0.13%) 
Endocrine disorders     
Ectopic hyperthyroidism  1  1/781 (0.13%)  0/778 (0.00%) 
Eye disorders     
Ophthalmic vein thrombosis  1  0/781 (0.00%)  1/778 (0.13%) 
Retinal artery occlusion  1  1/781 (0.13%)  0/778 (0.00%) 
Visual impairment  1  0/781 (0.00%)  1/778 (0.13%) 
Gastrointestinal disorders     
Abdominal pain  1  0/781 (0.00%)  1/778 (0.13%) 
Abdominal pain upper  1  1/781 (0.13%)  0/778 (0.00%) 
Anal fistula  1  0/781 (0.00%)  1/778 (0.13%) 
Colitis ischaemic  1  1/781 (0.13%)  2/778 (0.26%) 
Constipation  1  1/781 (0.13%)  0/778 (0.00%) 
Diarrhoea  1  0/781 (0.00%)  2/778 (0.26%) 
Diverticulum  1  0/781 (0.00%)  1/778 (0.13%) 
Diverticulum intestinal haemorrhagic  1  0/781 (0.00%)  1/778 (0.13%) 
Duodenal polyp  1  1/781 (0.13%)  0/778 (0.00%) 
Enteritis  1  0/781 (0.00%)  1/778 (0.13%) 
Gastritis erosive  1  1/781 (0.13%)  0/778 (0.00%) 
Gastrointestinal haemorrhage  1  0/781 (0.00%)  2/778 (0.26%) 
Intestinal infarction  1  0/781 (0.00%)  1/778 (0.13%) 
Intestinal ischaemia  1  0/781 (0.00%)  1/778 (0.13%) 
Intestinal obstruction  1  0/781 (0.00%)  1/778 (0.13%) 
Larger intestine perforation  1  0/781 (0.00%)  1/778 (0.13%) 
Oesophageal varices haemorrhage  1  1/781 (0.13%)  0/778 (0.00%) 
Pancreatic mass  1  0/781 (0.00%)  1/778 (0.13%) 
Pancreatitis  1  1/781 (0.13%)  0/778 (0.00%) 
Rectal haemorrhage  1  0/781 (0.00%)  1/778 (0.13%) 
Retroperitoneal haemorrhage  1  0/781 (0.00%)  1/778 (0.13%) 
Small intestinal obstruction  1  4/781 (0.51%)  0/778 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/781 (0.13%)  1/778 (0.13%) 
Vomiting  1  0/781 (0.00%)  1/778 (0.13%) 
General disorders     
Asthenia  1  0/781 (0.00%)  3/778 (0.39%) 
Chest pain  1  2/781 (0.26%)  3/778 (0.39%) 
Death  1  2/781 (0.26%)  1/778 (0.13%) 
Gait disturbance  1  0/781 (0.00%)  1/778 (0.13%) 
Hypothermia  1  0/781 (0.00%)  1/778 (0.13%) 
Multiple organ dysfunction syndrome  1  0/781 (0.00%)  1/778 (0.13%) 
Non-cardiac chest pain  1  10/781 (1.28%)  9/778 (1.16%) 
Pyrexia  1  1/781 (0.13%)  0/778 (0.00%) 
Sensation of foreign body  1  1/781 (0.13%)  0/778 (0.00%) 
Ulcer haemorrhage  1  0/781 (0.00%)  1/778 (0.13%) 
Vascular stent restenosis  1  0/781 (0.00%)  1/778 (0.13%) 
Hepatobiliary disorders     
Bile duct stone  1  1/781 (0.13%)  1/778 (0.13%) 
Cholecystitis  1  0/781 (0.00%)  1/778 (0.13%) 
Cholecystitis acute  1  1/781 (0.13%)  2/778 (0.26%) 
Cholelithiasis  1  0/781 (0.00%)  2/778 (0.26%) 
Hepatic cirrhosis  1  1/781 (0.13%)  0/778 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/781 (0.00%)  1/778 (0.13%) 
Infections and infestations     
Anal abscess  1  1/781 (0.13%)  0/778 (0.00%) 
Appendicitis  1  2/781 (0.26%)  1/778 (0.13%) 
Appendicitis perforated  1  1/781 (0.13%)  0/778 (0.00%) 
Arthritis infective  1  1/781 (0.13%)  0/778 (0.00%) 
Bacterial pyelonephritis  1  0/781 (0.00%)  1/778 (0.13%) 
Bronchitis  1  2/781 (0.26%)  2/778 (0.26%) 
Cavernous sinus thrombosis  1  0/781 (0.00%)  1/778 (0.13%) 
Cellulitis  1  4/781 (0.51%)  2/778 (0.26%) 
Clostridium difficile colitis  1  1/781 (0.13%)  1/778 (0.13%) 
Cystitis  1  1/781 (0.13%)  0/778 (0.00%) 
Device related infection  1  1/781 (0.13%)  0/778 (0.00%) 
Diabetic foot infection  1  1/781 (0.13%)  0/778 (0.00%) 
Diverticultis  1  2/781 (0.26%)  2/778 (0.26%) 
Escherichia bacteraemia  1  1/781 (0.13%)  1/778 (0.13%) 
Gangrene  1  0/781 (0.00%)  1/778 (0.13%) 
Gastroenteritis  1  2/781 (0.26%)  0/778 (0.00%) 
Gastroenteritis norovirus  1  0/781 (0.00%)  1/778 (0.13%) 
Infectious colitis  1  0/781 (0.00%)  1/778 (0.13%) 
Influenza  1  2/781 (0.26%)  1/778 (0.13%) 
Localised infection  1  2/781 (0.26%)  0/778 (0.00%) 
Osteomyelitis  1  1/781 (0.13%)  2/778 (0.26%) 
Osteomyelitis acute  1  1/781 (0.13%)  0/778 (0.00%) 
Periorbital cellulitis  1  1/781 (0.13%)  0/778 (0.00%) 
Periotinitis  1  1/781 (0.13%)  0/778 (0.00%) 
Pneumonia  1  11/781 (1.41%)  9/778 (1.16%) 
Pneumonia bacterial  1  1/781 (0.13%)  0/778 (0.00%) 
Pneumonia viral  1  1/781 (0.13%)  0/778 (0.00%) 
Post procedural infection  1  1/781 (0.13%)  0/778 (0.00%) 
Postoperative wound infection  1  0/781 (0.00%)  1/778 (0.13%) 
Pyelonephritis  1  0/781 (0.00%)  1/778 (0.13%) 
Sepsis  1  6/781 (0.77%)  4/778 (0.51%) 
Sepsis syndrome  1  0/781 (0.00%)  1/778 (0.13%) 
Septic shock  1  1/781 (0.13%)  1/778 (0.13%) 
Staphylococcal abscess  1  1/781 (0.13%)  0/778 (0.00%) 
Urinary tract infection  1  0/781 (0.00%)  3/778 (0.39%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  0/781 (0.00%)  1/778 (0.13%) 
Cardiac contusion  1  0/781 (0.00%)  1/778 (0.13%) 
Cardiac valve replacement complication  1  0/781 (0.00%)  1/778 (0.13%) 
Chemical burn  1  1/781 (0.13%)  0/778 (0.00%) 
Contusion  1  1/781 (0.13%)  0/778 (0.00%) 
Craniocerebral injury  1  0/781 (0.00%)  1/778 (0.13%) 
Facial bones fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Fall  1  2/781 (0.26%)  0/778 (0.00%) 
Femoral neck fracture  1  0/781 (0.00%)  2/778 (0.26%) 
Foot fracture  1  1/781 (0.13%)  0/778 (0.00%) 
Gun shot wound  1  0/781 (0.00%)  1/778 (0.13%) 
Head injury  1  1/781 (0.13%)  0/778 (0.00%) 
Hip fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Humerus fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Incisional hernia, obstructive  1  1/781 (0.13%)  0/778 (0.00%) 
Joint dislocation  1  1/781 (0.13%)  0/778 (0.00%) 
Lumbar vertebral fracture  1  1/781 (0.13%)  0/778 (0.00%) 
Multiple injuries  1  1/781 (0.13%)  0/778 (0.00%) 
Occupational exposure to product  1  1/781 (0.13%)  0/778 (0.00%) 
Post procedural haematuria  1  0/781 (0.00%)  1/778 (0.13%) 
Post procedural hawmorrhage  1  1/781 (0.13%)  0/778 (0.00%) 
Procedural pain  1  0/781 (0.00%)  1/778 (0.13%) 
Rib fracture  1  1/781 (0.13%)  1/778 (0.13%) 
Road traffic accident  1  1/781 (0.13%)  1/778 (0.13%) 
Spinal compression fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Subarachnoid haemorrhage  1  0/781 (0.00%)  1/778 (0.13%) 
Subdural haemorrhage  1  0/781 (0.00%)  1/778 (0.13%) 
Thoracic vertebral fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Tibia fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Vascular pseudoaneurysm  1  1/781 (0.13%)  0/778 (0.00%) 
Wrist fracture  1  0/781 (0.00%)  1/778 (0.13%) 
Investigations     
Blood pressure increased  1  0/781 (0.00%)  1/778 (0.13%) 
Metabolism and nutrition disorders     
Dehydration  1  0/781 (0.00%)  2/778 (0.26%) 
Diabetes Mellitus  1  0/781 (0.00%)  2/778 (0.26%) 
Diabetes mellitus inadequate control  1  0/781 (0.00%)  2/778 (0.26%) 
Diabetic ketoacidosis  1  1/781 (0.13%)  1/778 (0.13%) 
Fluid overload  1  1/781 (0.13%)  0/778 (0.00%) 
Gout  1  0/781 (0.00%)  2/778 (0.26%) 
Hypercalcaemia  1  1/781 (0.13%)  0/778 (0.00%) 
Hyperglycaemia  1  3/781 (0.38%)  0/778 (0.00%) 
Hyperkalaemia  1  0/781 (0.00%)  1/778 (0.13%) 
Hypoglycaemia  1  1/781 (0.13%)  0/778 (0.00%) 
Hypokalaemia  1  1/781 (0.13%)  1/778 (0.13%) 
Hyponatraemia  1  0/781 (0.00%)  1/778 (0.13%) 
Hypovolaemia  1  1/781 (0.13%)  1/778 (0.13%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/781 (0.26%)  0/778 (0.00%) 
Arthritis  1  0/781 (0.00%)  1/778 (0.13%) 
Back pain  1  1/781 (0.13%)  2/778 (0.26%) 
Cervical spinal stenosis  1  0/781 (0.00%)  3/778 (0.39%) 
Fracture malunion  1  0/781 (0.00%)  1/778 (0.13%) 
Intervertebral disc degeneration  1  0/781 (0.00%)  1/778 (0.13%) 
Lumbar spinal stenosis  1  1/781 (0.13%)  4/778 (0.51%) 
Muscular weakness  1  0/781 (0.00%)  1/778 (0.13%) 
Musculoskeletal pain  1  0/781 (0.00%)  1/778 (0.13%) 
Osteoarthritis  1  2/781 (0.26%)  2/778 (0.26%) 
Rhabdomyolysis  1  0/781 (0.00%)  1/778 (0.13%) 
Spinal column stenosis  1  1/781 (0.13%)  1/778 (0.13%) 
Spinal osteoarthritis  1  0/781 (0.00%)  2/778 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acute myeloid leukaemia  1  1/781 (0.13%)  0/778 (0.00%) 
Adenocarcinoma  1  0/781 (0.00%)  1/778 (0.13%) 
Adenocarcinoma of colon  1  0/781 (0.00%)  1/778 (0.13%) 
Bladder cancer  1  1/781 (0.13%)  0/778 (0.00%) 
Bladder transitional cell carcinoma  1  0/781 (0.00%)  1/778 (0.13%) 
Bowen's disease  1  3/781 (0.38%)  0/778 (0.00%) 
Breast cancer  1  1/781 (0.13%)  0/778 (0.00%) 
Breast cancer stage 1  1  0/781 (0.00%)  1/778 (0.13%) 
Carcinoid tumour of the stomach  1  0/781 (0.00%)  2/778 (0.26%) 
Clear cell renal cell carcinoma  1  0/781 (0.00%)  1/778 (0.13%) 
Colon cancer metastatic  1  0/781 (0.00%)  1/778 (0.13%) 
Endometrial cancer  1  0/781 (0.00%)  2/778 (0.26%) 
Gastrointestinal lymphoma  1  1/781 (0.13%)  0/778 (0.00%) 
Gastrooesophageal cancer  1  0/781 (0.00%)  1/778 (0.13%) 
Hepatic cancer  1  1/781 (0.13%)  0/778 (0.00%) 
Invasive ductal breast carcinoma  1  0/781 (0.00%)  1/778 (0.13%) 
Liposarcoma recurrent  1  0/781 (0.00%)  1/778 (0.13%) 
Lung adenocarcinoma  1  0/781 (0.00%)  3/778 (0.39%) 
Malignant melanoma  1  0/781 (0.00%)  1/778 (0.13%) 
Meningioma  1  0/781 (0.00%)  1/778 (0.13%) 
Metastases to central nervous system  1  1/781 (0.13%)  0/778 (0.00%) 
Metastases to liver  1  0/781 (0.00%)  2/778 (0.26%) 
Myelodyplastic syndrome  1  0/781 (0.00%)  1/778 (0.13%) 
Non-small cell lung cancer  1  1/781 (0.13%)  1/778 (0.13%) 
Pancreatic carcinoma metastatic  1  0/781 (0.00%)  1/778 (0.13%) 
Prostate cancer  1  4/781 (0.51%)  2/778 (0.26%) 
Prostate cancer recurrent  1  1/781 (0.13%)  1/778 (0.13%) 
Renal cancer  1  1/781 (0.13%)  0/778 (0.00%) 
Renal cell carcinoma  1  1/781 (0.13%)  0/778 (0.00%) 
Squamous cell carcinoma  1  3/781 (0.38%)  2/778 (0.26%) 
Squamous cell carcinoma of lung  1  2/781 (0.26%)  1/778 (0.13%) 
Squamous cell carcinoma of skin  1  5/781 (0.64%)  1/778 (0.13%) 
Nervous system disorders     
Carotid artery disease  1  1/781 (0.13%)  1/778 (0.13%) 
Carotid artery stenosis  1  3/781 (0.38%)  2/778 (0.26%) 
Cerebral haemorrhage  1  1/781 (0.13%)  0/778 (0.00%) 
Cerebral infarction  1  1/781 (0.13%)  1/778 (0.13%) 
Cerebrovascular accident  1  4/781 (0.51%)  3/778 (0.39%) 
Cerebrovascular disorder  1  1/781 (0.13%)  0/778 (0.00%) 
Cervical radiculopathy  1  0/781 (0.00%)  2/778 (0.26%) 
Demetia  1  0/781 (0.00%)  1/778 (0.13%) 
Dizziness  1  3/781 (0.38%)  0/778 (0.00%) 
Headache  1  1/781 (0.13%)  1/778 (0.13%) 
Hemiparesis  1  0/781 (0.00%)  1/778 (0.13%) 
Ischaemic stroke  1  7/781 (0.90%)  4/778 (0.51%) 
Metabolic encephalopathy  1  0/781 (0.00%)  1/778 (0.13%) 
Migraine  1  1/781 (0.13%)  0/778 (0.00%) 
Myelopathy  1  0/781 (0.00%)  1/778 (0.13%) 
Nerve compression  1  0/781 (0.00%)  1/778 (0.13%) 
Normal pressure hydrocephalus  1  0/781 (0.00%)  2/778 (0.26%) 
Presyncope  1  2/781 (0.26%)  0/778 (0.00%) 
Radiculopathy  1  0/781 (0.00%)  1/778 (0.13%) 
Seizure  1  0/781 (0.00%)  1/778 (0.13%) 
Spinal subdural haematoma  1  0/781 (0.00%)  1/778 (0.13%) 
Status migrainosus  1  1/781 (0.13%)  0/778 (0.00%) 
Syncope  1  4/781 (0.51%)  7/778 (0.90%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Inclisiran Saline Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   247/781 (31.63%)   219/778 (28.15%) 
Infections and infestations     
Bronchitis  1  46/781 (5.89%)  30/778 (3.86%) 
Metabolism and nutrition disorders     
Diabetes mellitus  1  120/781 (15.36%)  108/778 (13.88%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  39/781 (4.99%)  39/778 (5.01%) 
Vascular disorders     
Hypertension  1  42/781 (5.38%)  42/778 (5.40%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice-President, Regulatory Operations
Organization: The Medicines Company
Phone: 973-985-0597
EMail: frank.bosley@novartis.com
Layout table for additonal information
Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT03399370    
Other Study ID Numbers: MDCO-PCS-17-04
First Submitted: January 3, 2018
First Posted: January 16, 2018
Results First Submitted: July 1, 2020
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020