Trial · NCT07102628
Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
NCT07102628, Phase 3, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes. Trials, record NCT07102628. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07102628
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Efficacy and Safety of Early in Hospital Initiation of Inclisiran Treatment in Patients With Acute Coronary Syndromes
- NCT number
- NCT07102628
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 300 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Coronary Syndrome
- Interventions
- Placebo, Inclisiran
- First posted
- 2025-08-04
- Last updated
- 2026-09-16
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent change in LDL-C | From baseline to Day 150 | To demonstrate the superiority of inclisiran treatment compared to placebo, when initiated before/at discharge, in combination with standard of care (SoC) (statin therapy +/- LLT (Lipid Lowering Therapy) or non-statin treatment in case of documented statin intolerance) on LDL-C reduction at Day 150 |
| Secondary | Participants achieving LDL-C <70 mg/dL (yes, no) | At Day 90 and Day 150 | To assess the proportion of participants reaching pre-specified LDL-C target (\<70 mg/dL) on inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Participants achieving LDL-C <55 mg/dL (yes, no) | At Day 90 and Day 150 | To assess the proportion of participants reaching pre-specified LDL-C target (\<55 mg/dL) on inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) | At Day 90 and Day 150 | To assess the proportion of participants reaching pre-specified LDL-C target (\<100 mg/dL) on inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) | At Day 90 and Day 150 | To assess the proportion of participants reaching pre-specified LDL-C target (≥50% reduction from baseline) on inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) | From baseline to Day 30, Day 90 and Day 150 | To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) | From baseline to Day 30, Day 90 and Day 150 | To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Percent change in LDL-C | From baseline to Day 30 and Day 90 | To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Absolute change in LDL-C | From baseline to Day 30, Day 90 and Day 150 | To assess the mean change (averaged over all post-baseline visits), and the change by visit, from baseline in LDL-C for participants receiving inclisiran treatment compared to placebo, on top of SoC |
| Secondary | Percent change and absolute change in PCSK9 | From baseline to Day 30, Day 90 and Day 150 | To assess the change of PCSK9 from baseline to Day 150 in participants on inclisiran treatment compared to placebo, on top of SoC |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07102628
GET https://conductscience.org/api/trials/v1/NCT07102628/registered