Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
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 care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inclisiran with Usual Care | Experimental | Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) |
|
| Usual Care | No Intervention | Usual Care Alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inclisiran | Drug | Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline to Day 330 in LDL-C | Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330 | Baseline and Day 330 |
| Achievement of LDL-C < 70 mg/dL at Day 330 | Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 70 mg/dL at Day 330 | Day 330 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in LDL-C | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit | Baseline, Day 90, Day 270 and Day 330 |
| Average Percent Change From Baseline in LDL-C Levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Arkansas Baptist Clinic | Jonesboro | Arkansas | 72401 | United States | ||
| Central Cardiology Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42132192 | Derived | Knowlton KU, Navar AM, Anderson JL, Brown AS, Muhlestein JB, Kleeman K, Sarwat S, Abbas CA, Ramirez MA, Grines CL, Abo-Auda WS, Desai NR. Low-Density Lipoprotein Cholesterol Lowering With Inclisiran Plus Usual Care in Recent Acute Coronary Syndrome: VICTORION-INCEPTION, a Randomized, Controlled, Open-Label Trial. J Am Heart Assoc. 2026 May 19;15(10):e043655. doi: 10.1161/JAHA.125.043655. Epub 2026 May 14. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on www.novctrd.com | View source |
Not provided
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Not provided
Not provided
Not provided
Not provided
Not provided
This study was conducted at 87 study centers. Of the 201 participants randomized to inclisiran + usual care, 1 participant was randomized erroneously and did not receive inclisiran. Of the 199 participants randomized to usual care, 3 participants received commercially available inclisiran as part of their concomitant medications.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Inclisiran With Usual Care | Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care |
| FG001 | Usual Care | Usual Care Alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 20, 2022 | Aug 1, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit
| Baseline, from Day 90 to Day 330 |
| Average Absolute Change From Baseline in LDL-C Levels | Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit | Baseline, From Day 90 to Day 330 |
| Achieving ≥50% Reduction From Baseline in LDL-C | Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330 | Baseline, Day 330 |
| Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) <100 mg/dL (among the subset of participants with baseline LDL-C >= 100 mg/dL) and LDL-C < 55 mg/dL at Day 330 | Day 330 |
| Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp[a]), HDL-C and triglycerides from baseline to Day 330 | Baseline and Day 330 |
| Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330 | Baseline and Day 330 |
| Absolute Change in Lp[a] From Baseline to Day 330 | Absolute change in lipoprotein(a) (Lp[a]) from baseline to Day 330 | Baseline and Day 330 |
| Intensity of Lipid Lowering Therapy | Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change) | Baseline and Day 330 |
| Proportion of Days Covered | Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero. | Baseline through last date of participation, up to 330 Days |
| Discontinuation of Statin Therapy | Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit. Participants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy. | Baseline and Day 330 |
| Bakersfield |
| California |
| 93308 |
| United States |
| The Heart Group Cardiovascular Associates Inc | Fresno | California | 93720 | United States |
| Mission Heritage Medical Group | Mission Viejo | California | 92691 | United States |
| Northbay Clinical Research LLC | Santa Rosa | California | 95405 | United States |
| Clinnova Research Solutions | Torrance | California | 90277 | United States |
| Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Interv Cardiology Med Grp | West Hills | California | 91307 | United States |
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | United States |
| Colorado Springs Cardiology | Colorado Springs | Colorado | 80907 | United States |
| Colorado Heart and Vascular | Lakewood | Colorado | 80228 | United States |
| Cardiology Ass of Fairfield County | Stamford | Connecticut | 06905 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| George Washington Univ Medical Ctr | Washington D.C. | District of Columbia | 20037 | United States |
| Nova Clinical Research LLC | Bradenton | Florida | 34209 | United States |
| Teradan Clinical trials LLC | Brandon | Florida | 33511 | United States |
| Clearwater Cardiovascular and Interventional Consultants | Clearwater | Florida | 33756 | United States |
| Cardiology Research Associates | Daytona Beach | Florida | 32117 | United States |
| Holy Cross Hospital Inc | Fort Lauderdale | Florida | 33308 | United States |
| Baptist Health Research Institute | Jacksonville | Florida | 32207 | United States |
| Reliant Medical Research | Miami | Florida | 33165 | United States |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | United States |
| Innovation Medical Group LLC | Palmetto Bay | Florida | 33157 | United States |
| Cardiology Consultants | Pensacola | Florida | 32501 | United States |
| Theia Clinical Research Ctrs LLC | Tampa | Florida | 33613 | United States |
| Morehouse School Of Medicine | Atlanta | Georgia | 30310 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Ellipsis Group | Atlanta | Georgia | 30342 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Northwest Heart Clinical Rsrch LLC | Arlington Heights | Illinois | 60005 | United States |
| AMITA Heart and Vascular Group | Hinsdale | Illinois | 60521 | United States |
| Franciscan Health Services Research Center | Indianapolis | Indiana | 46237 | United States |
| Cardiovascular Research Of Northwest Indiana, Llc | Munster | Indiana | 46321 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50314 | United States |
| Midwest Heart and Vascular Spec | Overland Park | Kansas | 66211 | United States |
| Tidal Health Peninsula Regional Inc | Salisbury | Maryland | 21804 | United States |
| Sparrow Clincal Research Institute | Lansing | Michigan | 48912 | United States |
| MidMichigan Physicians Group | Midland | Michigan | 48640 | United States |
| St Marys of Ascension Research | Saginaw | Michigan | 48601 | United States |
| Trinity Health Michigan Heart | Ypsilanti | Michigan | 48197 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| CentraCare Heart and Vascular Center | Saint Cloud | Minnesota | 56303 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Cardiology Associates of North MS | Tupelo | Mississippi | 38801 | United States |
| St Louis Heart and Vascular | St Louis | Missouri | 63136 | United States |
| Bryan LGH Heart Inst Intigrated Cardiology Group | Lincoln | Nebraska | 68506 | United States |
| Meridian Clinical Research | Lincoln | Nebraska | 68506 | United States |
| Advanced Heart Care, LLC | Bridgewater | New Jersey | 08807 | United States |
| Cardiovas Assoc of Delaware Valley | Elmer | New Jersey | 08318 | United States |
| Inspira Medical Cent Mullica Hill | Mullica Hill | New Jersey | 08062 | United States |
| Capital Cardiology Associates | Albany | New York | 12211 | United States |
| University At Buffalo | Buffalo | New York | 14203 | United States |
| Bassett Medical Center | Cooperstown | New York | 13326 | United States |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | United States |
| Northwell Health | Manhasset | New York | 11030 | United States |
| Laurelton Heart Specialist PC | Rosedale | New York | 11422 | United States |
| Cary Research Group | Cary | North Carolina | 27511 | United States |
| Moses Cone Hospital-Lebauer CV Research Foundation | Greensboro | North Carolina | 27403 | United States |
| Clinical Trials Of America LLC | Lenoir | North Carolina | 28645 | United States |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | United States |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| St John Health System | Bartlesville | Oklahoma | 74006 | United States |
| Bend Memorial Clinic | Bend | Oregon | 97701 | United States |
| University of Pittsburgh Medical Center HABOT | Erie | Pennsylvania | 16550 | United States |
| Lancaster General Health | Lancaster | Pennsylvania | 17602 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | United States |
| Covenant Medical Group | Knoxville | Tennessee | 37916 | United States |
| Baylor Scott and White Heart and Vascular Hospital | Dallas | Texas | 75226 | United States |
| Vilo Research Group LLC | Houston | Texas | 77017 | United States |
| Texas Heart Medical Group | Houston | Texas | 77030 | United States |
| UT Physicians Memorial Hermann | Houston | Texas | 77030 | United States |
| Northwest Houston Cardiology PA | Houston | Texas | 77070 | United States |
| West Houston Area Clinical Trial Consultants | Houston | Texas | 77094 | United States |
| The Heart Institute of East Texas | Lufkin | Texas | 75904 | United States |
| CardioVoyage LLC | McKinney | Texas | 75071 | United States |
| Research Group of North Texas | Sunnyvale | Texas | 75182 | United States |
| Tyler Cardiovascular Consultants | Tyler | Texas | 75701 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23608 | United States |
| York Clinical Research | Norfolk | Virginia | 23504 | United States |
| Dominion Medical Associates | Richmond | Virginia | 23219 | United States |
| Carilion Clinic | Roanoke | Virginia | 24013 | United States |
| Selma Medical Associates | Winchester | Virginia | 22601 | United States |
| MultiCare Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Full Analysis Set | Full Analysis Set (FAS) included all randomized participants |
|
| Safety Set | Safety Set included all participants who received study treatment. Participants in the usual care treatment group who had data collected at the baseline visit were included in the Safety Set. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inclisiran With Usual Care | Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care |
| BG001 | Usual Care | Usual Care Alone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline to Day 330 in LDL-C | Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330 | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had LDL-C values at baseline and Day 330. | Posted | Least Squares Mean | 97.5% Confidence Interval | Percent change in LDL-C | Baseline and Day 330 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Achievement of LDL-C < 70 mg/dL at Day 330 | Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) < 70 mg/dL at Day 330 | Full Analysis Set (FAS) comprised all randomized participants. | Posted | Number | 97.5% Confidence Interval | Percentage of participants | Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in LDL-C | Absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) by visit | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had LDL-C values at baseline and Day 90, Day 270 and Day 330 respectively. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline, Day 90, Day 270 and Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Percent Change From Baseline in LDL-C Levels | Average percent change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had at least one LDL-C change from baseline value available. | Posted | Least Squares Mean | 95% Confidence Interval | Average percent change in LDL-C | Baseline, from Day 90 to Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Absolute Change From Baseline in LDL-C Levels | Average absolute change from baseline in low-density lipoprotein cholesterol (LDL-C) levels to each post-baseline visit | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had at least one LDL-C change from baseline value available. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline, From Day 90 to Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achieving ≥50% Reduction From Baseline in LDL-C | Percentage of participants achieving ≥50% reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at Day 330 | Full Analysis Set (FAS) comprised all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline, Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL | Percentage of participants achieving low-density lipoprotein cholesterol (LDL-C) <100 mg/dL (among the subset of participants with baseline LDL-C >= 100 mg/dL) and LDL-C < 55 mg/dL at Day 330 | Full Analysis Set (FAS) comprised all randomized participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Percent change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, lipoprotein(a) (Lp[a]), HDL-C and triglycerides from baseline to Day 330 | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330. | Posted | Least Squares Mean | 95% Confidence Interval | Percent change | Baseline and Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330 | Absolute change in apolipoprotein B, very-low-density lipoprotein (VLDL), non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol, HDL-C and triglycerides from baseline to Day 330 | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Lp[a] From Baseline to Day 330 | Absolute change in lipoprotein(a) (Lp[a]) from baseline to Day 330 | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had values at baseline and Day 330. | Posted | Least Squares Mean | 95% Confidence Interval | nmol/L | Baseline and Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Intensity of Lipid Lowering Therapy | Percentage of participants by intensity of lipid lowering therapy (dose decrease, increase or no change) | Full Analysis Set (FAS) comprised all randomized participants. The number of participants analyzed corresponds to the number of subjects who had a record for Day 330 study visit date. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Day 330 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Days Covered | Total number of days on either statin, ezetimibe, or PCSK9 inhibiting monoclonal antibody therapies divided by total number of study days. If a participant did not take any of the 3 medications, then the total number of days was assumed to be zero. | Full Analysis Set (FAS) comprised all randomized participants. | Posted | Least Squares Mean | 95% Confidence Interval | Proportion of days | Baseline through last date of participation, up to 330 Days |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Discontinuation of Statin Therapy | Percentage of participants discontinuing statin therapy. Discontinuation of statin therapy was defined as no statin use ≥ 30 days before the end-of-study visit. Participants for whom it could not be ascertained that they were on statin therapy at the end of study or who discontinued from the study early were assumed to have discontinued statin therapy. | Full Analysis Set (FAS) comprised all randomized participants. Participants with Medical History of Statin Intolerance were excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline and Day 330 |
|
|
Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of 330 days.
All safety analyses were conducted in the Safety Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inclisiran + Usual Care | Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran) + usual care | 0 | 203 | 32 | 203 | 52 | 203 |
| EG001 | Usual Care | Usual Care Alone | 2 | 197 | 34 | 197 | 35 | 197 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Microcytic anaemia | Blood and lymphatic system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac perfusion defect | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Heart failure with preserved ejection fraction | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Varicella zoster virus infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (27.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (27.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Renal artery thrombosis | Renal and urinary disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Obstructive sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (27.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (27.0) | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (27.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (27.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (27.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (27.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | + 1 862 778 8300 | Novartis.email@Novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 29, 2024 | Aug 1, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006949 | Hyperlipidemias |
| D050197 | Atherosclerosis |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C585830 | ALN-PCS |
Not provided
Not provided
Not provided
| Male |
|
| Black or African American |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| American Indian or Alaska Native |
|
| Unknown |
|
| Multiple |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|