Search
Close this search box.

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Studies

Study First Submitted Date 2022-12-02
Study First Posted Date 2022-12-12
Last Update Posted Date 2023-07-25
Start Month Year March 27, 2024
Primary Completion Month Year September 5, 2028
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-25

Conditions

Sequence: 52253029
Name Aortic Stenosis
Downcase Name aortic stenosis

Id Information

Sequence: 40218310
Id Source org_study_id
Id Value CTQJ230A12203

Design Groups

Sequence: 55684950 Sequence: 55684951
Group Type Experimental Group Type Placebo Comparator
Title Pelacarsen (TQJ230) 80mg Title Matching placebo
Description Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously Description Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously

Interventions

Sequence: 52565914 Sequence: 52565915
Intervention Type Drug Intervention Type Drug
Name Pelacarsen (TQJ230) 80mg Name Matching placebo
Description Pelacarsen (TQJ230) 80mg Description Matching placebo

Keywords

Sequence: 79984639 Sequence: 79984640 Sequence: 79984641 Sequence: 79984642 Sequence: 79984643 Sequence: 79984644
Name Cardiovascular Name Lipoprotein(a) Name Lp(a) Name Calcific aortic valve stenosis Name TQJ230 Name Pelacarsen
Downcase Name cardiovascular Downcase Name lipoprotein(a) Downcase Name lp(a) Downcase Name calcific aortic valve stenosis Downcase Name tqj230 Downcase Name pelacarsen

Design Outcomes

Sequence: 177679097 Sequence: 177679098 Sequence: 177679099 Sequence: 177679100 Sequence: 177679101
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Change in peak aortic jet velocity Measure Change in aortic valve calcium score Measure Change in Lp(a) levels Measure Change in fibrocalcific thickening of the aortic valve Measure Time from randomization to first occurrence of composite clinical endpoint event
Time Frame 36 months Time Frame 36 months Time Frame 12 months Time Frame 36 months Time Frame Up to 36 months
Description To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in peak aortic jet velocity by echocardiography Description To demonstrate the superiority of pelacarsen (TQJ230) vs. placebo in slowing the progression of calcific aortic valve stenosis by evaluating the change from baseline to month 36 in aortic valve calcium score by computed tomography Description To assess the effect of pelacarsen (TQJ230) vs. placebo on the reduction of Lp(a) levels from baseline to month 12 Description To assess the effect of pelacarsen (TQJ230) vs. placebo in slowing the progression of CAVS by evaluating the change from baseline to month 36 in fibrocalcific thickening of the aortic valve by contrast CT Description To assess the effect of pelacarsen (TQJ230) vs. placebo in reducing the risk of composite clinical endpoint defined as reaching either: Hospitalization due to symptoms of CAVS Requirement of AVI Death related to CAVS

Browse Conditions

Sequence: 193799696 Sequence: 193799697 Sequence: 193799698 Sequence: 193799699 Sequence: 193799700 Sequence: 193799701 Sequence: 193799702 Sequence: 193799703
Mesh Term Aortic Valve Stenosis Mesh Term Constriction, Pathologic Mesh Term Pathological Conditions, Anatomical Mesh Term Aortic Valve Disease Mesh Term Heart Valve Diseases Mesh Term Heart Diseases Mesh Term Cardiovascular Diseases Mesh Term Ventricular Outflow Obstruction
Downcase Mesh Term aortic valve stenosis Downcase Mesh Term constriction, pathologic Downcase Mesh Term pathological conditions, anatomical Downcase Mesh Term aortic valve disease Downcase Mesh Term heart valve diseases Downcase Mesh Term heart diseases Downcase Mesh Term cardiovascular diseases Downcase Mesh Term ventricular outflow obstruction
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48396094
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Novartis Pharmaceuticals

Overall Officials

Sequence: 29329858
Role Study Director
Name Novartis Pharmaceuticals
Affiliation Novartis Pharmaceuticals

Central Contacts

Sequence: 12028068 Sequence: 12028069
Contact Type primary Contact Type backup
Name Novartis Pharmaceuticals Name Novartis Pharmaceuticals
Phone 1-888-669-6682 Phone +41613241111
Email novartis.email@novartis.com
Role Contact Role Contact

Design Group Interventions

Sequence: 68259713 Sequence: 68259714
Design Group Id 55684950 Design Group Id 55684951
Intervention Id 52565914 Intervention Id 52565915

Eligibilities

Sequence: 30813112
Gender All
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Male and female ≥50 years of age Lp(a) ≥125 nmol/L at the screening visit, measured at the Central laboratory Mild or moderate calcific aortic valve stenosis Exclusion Criteria: Severe calcific aortic valve stenosis Uncontrolled hypertension History of malignancy of any organ system History of hemorrhagic stroke or other major bleeding Platelet count ≤ LLN Active liver disease or hepatic dysfunction Significant kidney disease Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254060701
Registered In Calendar Year 2022
Were Results Reported False
Has Single Facility False
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30559081
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Double
Masking Description Double-blind study
Subject Masked True
Investigator Masked True

Intervention Other Names

Sequence: 26711326 Sequence: 26711327
Intervention Id 52565914 Intervention Id 52565915
Name TQJ230 Name Placebo

Responsible Parties

Sequence: 28925478
Responsible Party Type Sponsor