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NCT04023552 · ClinicalTrials.gov registry record · Phase 3
Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD
A Phase 3 study of Cardiovascular Disease and Lipoprotein(a), sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 8,323
- Enrollment target
- 20
- Study locations
NCT04023552: Active Phase 3 study of Cardiovascular Disease and Lipoprotein(a), sponsored by Novartis Pharmaceuticals.
NCT04023552 is a Phase 3 study of Cardiovascular Disease and Lipoprotein(a) that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 8,323 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (980% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04023552, a Phase 3 study of Cardiovascular Disease and Lipoprotein(a), is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 8,323 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
Primary Outcome
Demonstrate the superiority of pelacarsen (TQJ230) compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and (Lp(a) ≥ 70 mg/dL)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TQJ230
Study Locations (20)
Alabama
- SEC Clinical Research LLC - Andalusia
- Grandview Med Group Research LLC - Birmingham
- Novartis Investigative Site - Birmingham
- Heart Center Research Llc - Huntsville
- Novartis Investigative Site - Huntsville
- Mobile Heart Specialists - Mobile
- Novartis Investigative Site - Mobile
Arizona
- Novartis Investigative Site - Cottonwood
- Mercy Gilbert Medical Center - Gilbert
- Clinical Research Inst of Arizona - Sun City West
- Novartis Investigative Site - Sun City West
- Eclipse Clinical Research - Tucson
- Novartis Investigative Site - Tucson
California
- Cardiovascular Res Found - Beverly Hills
- National Heart Institute - Beverly Hills
- Novartis Investigative Site - Beverly Hills
- Flourish Clinical Resrch Covin - Covina
- Novartis Investigative Site - Covina
Arkansas
- Cardiology and Medicine Clinic PA - Little Rock
- Novartis Investigative Site - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,323 participants |
| Start Date | 2019-12-12 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 3 |
What the registry record for NCT04023552 still lists
NCT04023552 is an interventional study that assigns participants to a tested intervention. Its 8,323 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (980% higher).
The record links to 1 condition, with Cardiovascular Disease and Lipoprotein(a) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04023552 names 20 study sites across 4 states, led by Alabama, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04023552 about?
NCT04023552 is a clinical study titled "Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD". This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)
What is the current status of trial NCT04023552?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 8,323 participants. The study started on 2019-12-12. Estimated completion is 2026-06-30.
What conditions does trial NCT04023552 study?
This clinical trial studies the following conditions: Cardiovascular Disease and Lipoprotein(a).
What interventions are being tested in trial NCT04023552?
The interventions under investigation include: Placebo (DRUG), TQJ230 (DRUG).
Who is sponsoring clinical trial NCT04023552?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04023552 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04023552's enrollment target sits among peer trials
8,323 32nd of 2000 higher than 1,969 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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