Acute Coronary Syndrome (ACS)
Conditions
Keywords
Lipoprotein(a), ASCVD, Acute Coronary Syndrome (ACS), STEMI, NSTEMI, pelacarsen (TQJ230)
Brief summary
CTQJ230A1US13 is a randomized, double-blind, placebo-controlled, multicenter phase IIIb study designed to evaluate the efficacy, safety, tolerability, and coronary plaque effects of early pelacarsen (TQJ230) initiation in participants with elevated Lp(a) and recent acute coronary syndrome (ACS).
Detailed description
This study consists of Lp(a) measurement and additional screening assessments, a double-blind treatment period of 18 months, and a 16-week safety follow up period from the last dose. Efficacy, safety, and tolerability of pelacarsen (TQJ230) compared to placebo will be assessed throughout the study, with primary analysis at Day 180 and final analysis at Day 540.
Interventions
DRUGPelacarsen
Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
DRUGPlacebo
Placebo subcutaneously (s.c.) once a month (QM)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Lp(a) ≥ 150 nmol/L * Within 10 days of hospitalization for ACS event and meets all of the following criteria: * Clinical syndrome consistent with spontaneous cardiac ischemia * Diagnosis of ACS: ST-elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI)
Exclusion criteria
* Uncontrolled hypertension * Heart failure New York Heart Association (NYHA) class IV * History of malignancy of any organs * History of hemorrhagic stroke or other major bleeding * Platelet count ≤ LLN * Active liver disease or hepatic dysfunction * Significant kidney disease * Contraindication for CCTA or severe contrast allergy * Pregnant or nursing women Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in log-transformed Lp(a) concentration | Baseline, Day 180 | Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with Lp(a) < 105 nmol/L | Day 180 and Day 540 | Proportion of participants with Lipoprotein A (Lp(a)) \< 105 nmol/L |
| Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest | 22 months | Proportion of participants with: * Treatment-emergent adverse events (TEAEs) * Treatment-emergent serious adverse events (TESAEs) * TEAEs or TESAEs leading to study drug discontinuation * TEAEs of special interest |
| Summary of observed values for Glomerular Filtration Rate (GFR) | Up to 18 months | Summary of observed values in GFR (Safety laboratory parameters) |
| Change from baseline in Glomerular Filtration Rate (GFR) | Baseline and up to 18 months | Change from baseline in GFR (Safety laboratory parameters) |
| Summary of observed values for Heart Rate (HR) | Up to 18 months | Summary of observed values for HR (electrocardiogram) |
| Change from baseline in Heart Rate (HR) | Baseline and up to 18 months | Change from baseline in HR (electrocardiogram) |
| Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 18 months | Summary of observed values for SBP and DBP (vital signs) |
| Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to 18 months | Change from baseline in SBP and DBP (vital signs) |
| Change from baseline to Day 540 in non-calcified coronary plaque volume | Baseline and Day 540 | Change from baseline to Day 540 in non-calcified coronary plaque volume, as assessed by CCTA |
Contacts
CONTACTNovartis Pharmaceuticals
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed