Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01327846 · ClinicalTrials.gov registry record · Phase 3
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,066
- Enrollment target
NCT01327846: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01327846 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 10,066 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (1206% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327846, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,066 participants
- Enrollment target
Study Summary
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.
Primary Outcome
Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.
Interventions
- DRUG Placebo
- DRUG Canakinumab
- DRUG Standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,066 participants |
| Start Date | 2011-04-11 |
| Est. Completion | 2019-04-14 |
| Phase | Phase 3 |
What the finished NCT01327846 record still lists
NCT01327846 is an interventional study that assigns participants to a tested intervention. Its 10,066 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 (1206% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01327846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01327846 about?
NCT01327846 is a clinical study titled "Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)". Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the ex...
What is the current status of trial NCT01327846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,066 participants. The study started on 2011-04-11. Estimated completion is 2019-04-14.
What interventions are being tested in trial NCT01327846?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG), Standard of care (DRUG).
Who is sponsoring clinical trial NCT01327846?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01327846's enrollment target sits among peer trials
10,066 27th of 2000 higher than 1,974 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04332783 · 10,120 participants · NA
Isolating and Mitigating Sequentially Dependent Perceptual Errors in Clinical Visual Search
- NCT00160771 · 10,000 participants
Biomechanics/Motion Analysis Laboratory Data Bank
- NCT00896935 · 10,000 participants
Arizona Cancer Center Biospecimen Repository
- NCT00898235 · 10,000 participants
Collection of Samples and Clinical Data From Patients With Amyloid Diseases
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI