Acute Coronary Syndrome (ACS)Phase 3NCT07625306
Lp(a) Lowering Study of Pelacarsen (TQJ230) in Patients in the US With Elevated Lp(a) and Recent ACS (STEMI/NSTEMI) - Lp(a)FRONTIERS PEARL
A Phase 3 study testing Pelacarsen in people with Acute Coronary Syndrome (ACS), run by Novartis Pharmaceuticals.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Coronary Syndrome (ACS)
- What is being tested?
- Pelacarsen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 22 Jan 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- Significant kidney disease
- Contraindication for CCTA or severe contrast allergy
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability, and Coronary Plaque Effects of Early Pelacarsen (TQJ230) Initiation in Patients in the US With Elevated Lp(a) and Recent Acute Coronary Syndrome
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).
Read the 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.
- Conditions
- Acute Coronary Syndrome (ACS)
- Being tested
- Pelacarsen, Placebo
- Keywords
- Lipoprotein(a), ASCVD, Acute Coronary Syndrome (ACS), STEMI, NSTEMI, pelacarsen (TQJ230)
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PelacarsenDrug
Also called TQJ230
Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM)
PlaceboDrug
Placebo subcutaneously (s.c.) once a month (QM)
| Study group | Role | What they receive |
|---|---|---|
| Pelacarsen | Experimental | Pelacarsen (TQJ230) 80 mg s.c. QM Receives: Drug: Pelacarsen |
| Placebo | Placebo comparator | Corresponding placebo s.c. QM Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in log-transformed Lp(a) concentration
Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180
Measured: Baseline, Day 180
Secondary outcomes (9)
Proportion of participants with Lp(a) < 105 nmol/L
Proportion of participants with Lipoprotein A (Lp(a)) < 105 nmol/L
Measured: Day 180 and Day 540
Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest
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
Measured: 22 months
Summary of observed values for Glomerular Filtration Rate (GFR)
Summary of observed values in GFR (Safety laboratory parameters)
Measured: Up to 18 months
Change from baseline in Glomerular Filtration Rate (GFR)
Change from baseline in GFR (Safety laboratory parameters)
Measured: Baseline and up to 18 months
Summary of observed values for Heart Rate (HR)
Summary of observed values for HR (electrocardiogram)
Measured: Up to 18 months
Change from baseline in Heart Rate (HR)
Change from baseline in HR (electrocardiogram)
Measured: Baseline and up to 18 months
Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Summary of observed values for SBP and DBP (vital signs)
Measured: Up to 18 months
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Change from baseline in SBP and DBP (vital signs)
Measured: Baseline and up to 18 months
Change from baseline to Day 540 in non-calcified coronary plaque volume
Change from baseline to Day 540 in non-calcified coronary plaque volume, as assessed by CCTA
Measured: Baseline and Day 540
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Sep 2026
- Primary completion22 Jan 2029 (estimated)
- Study completion22 Jan 2029 (estimated)
Why it stopped: Study terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndrome (ACS)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07625306
- Sponsor's protocol ID
- CTQJ230A1US13
- Status last verified
- Oct 2026
- First submitted
- 27 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Study Evaluating the Efficacy, Safety, Tolerability, and Coronary Plaque Effects of Early Pelacarsen (TQJ230) Initiation in Patients in the US With Elevated Lp(a) and Recent Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT07625306
- Acronym / sponsor ID
- CTQJ230A1US13
- Conditions
- Acute Coronary Syndrome (ACS)
- Keywords
- Lipoprotein(a), ASCVD, Acute Coronary Syndrome (ACS), STEMI, NSTEMI, pelacarsen (TQJ230)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated by sponsor following the outcome of the Lp(a)HORIZON study (NCT04023552), which did not meet its primary endpoint
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 22 Jan 2029 (estimated)
- Study completion
- 22 Jan 2029 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelacarsen | Experimental | Drug: PelacarsenPelacarsen (TQJ230) 80 mg s.c. QM |
| Placebo | Placebo comparator | Drug: PlaceboCorresponding placebo s.c. QM |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PelacarsenAlso: TQJ230Pelacarsen 80 mg subcutaneously (s.c.) once a month (QM) | Drug | Pelacarsen |
| PlaceboPlacebo subcutaneously (s.c.) once a month (QM) | Drug | Placebo |
Primary outcome
Change in log-transformed Lp(a) concentration
Time frame: Baseline, Day 180
Change in log-transformed Lipoprotein A (Lp(a)) concentration from baseline to Day 180
9 secondary outcomes
Proportion of participants with Lp(a) < 105 nmol/L
Time frame: Day 180 and Day 540
Proportion of participants with TEAEs, TESAEs,TEAEs or TESAEs leading to study drug discontinuation and TEAEs of special interest
Time frame: 22 months
Summary of observed values for Glomerular Filtration Rate (GFR)
Time frame: Up to 18 months
Change from baseline in Glomerular Filtration Rate (GFR)
Time frame: Baseline and up to 18 months
Summary of observed values for Heart Rate (HR)
Time frame: Up to 18 months
Change from baseline in Heart Rate (HR)
Time frame: Baseline and up to 18 months
Summary of observed values for Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Up to 18 months
Change from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time frame: Baseline and up to 18 months
Change from baseline to Day 540 in non-calcified coronary plaque volume
Time frame: Baseline and Day 540
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pelacarsen in people with Acute Coronary Syndrome (ACS), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in log-transformed Lp(a) concentration (time frame: Baseline, Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.