Trial · NCT02924727
Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
NCT02924727, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2023-06-22
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI. Trials, record NCT02924727. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02924727
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
- NCT number
- NCT02924727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,669 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Acute Myocardial Infarction
- Interventions
- LCZ696 (sacubitril/valsartan), Ramipril, Placebo of LCZ696, Placebo of ramipril, Valsartan, Placebo of valsartan
- First posted
- 2016-10-05
- Last updated
- 2023-06-22
- Other registries' IDs
- eudract:2016-002154-20
- Results first posted
- 2023-06-22
- Limitations and caveats
- In this study there were 25 patients who did not take study treatment after randomization, and thus were not included in the safety set.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | From randomization to first occurrence (up to approximately 43 months) | A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure |
| Secondary | Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization | Time from randomization to first occurrence (up to approximately 43 months) | A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization. |
| Secondary | Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF | Time from randomization to first occurrence (approximately up to 43 months) | A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure |
| Secondary | Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke | Time from randomization to first occurrence (approximately up to 43 months) | A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke |
| Secondary | Total Number of Confirmed Composite Endpoints | Time from randomization to end of study (approximately up to 43 months) | A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization |
| Secondary | All-cause Mortality for Full Analysis Set (FAS) | Time from randomization to death (approximately up to 43 months) | All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set up to a cut-off date of 31-Dec-2020. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | From randomization to first occurrence (up to approximately 43 months) | Full Analysis Set | Count of Participants | NUMBER |
| SECONDARY | Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization | Time from randomization to first occurrence (up to approximately 43 months) | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF | Time from randomization to first occurrence (approximately up to 43 months) | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke | Time from randomization to first occurrence (approximately up to 43 months) | Full Analysis Set | Participants | NUMBER |
| SECONDARY | Total Number of Confirmed Composite Endpoints | Time from randomization to end of study (approximately up to 43 months) | Full Analysis Set | Events | NUMBER |
| SECONDARY | All-cause Mortality for Full Analysis Set (FAS) | Time from randomization to death (approximately up to 43 months) | Full Analysis Set | Participants | NUMBER |
| POST_HOC | All Collected Deaths | Pre-treatment: Up to 5 days before Day 1. On-treatment and post-treatment safety follow up: up to 4 years | All subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | LCZ696 (Sacubitril/Valsartan) | Primary Composite | 338 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | Ramipril | Primary Composite | 373 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | LCZ696 (Sacubitril/Valsartan) | Cardiovascular (CV) Death | 168 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | Ramipril | Cardiovascular (CV) Death | 191 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | LCZ696 (Sacubitril/Valsartan) | First Heart Failure (HF) Hospitalization | 170 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | Ramipril | First Heart Failure (HF) Hospitalization | 195 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | LCZ696 (Sacubitril/Valsartan) | First Outpatient Heart Failure (HF) | 39 | Count of Participants | |
| Number of Participants With First CEC (Clinical Endpoint Committee) Confirmed Primary Composite Endpoint | Ramipril | First Outpatient Heart Failure (HF) | 57 | Count of Participants | |
| Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization | LCZ696 (Sacubitril/Valsartan) | 308 | Participants | ||
| Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization | Ramipril | 335 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 (Sacubitril/Valsartan) | 2,834 | |
| Overall Study | STARTED | Ramipril | 2,835 | |
| Overall Study | Full Analysis Set (FAS) | LCZ696 (Sacubitril/Valsartan) | 2,830 | |
| Overall Study | Full Analysis Set (FAS) | Ramipril | 2,831 | |
| Overall Study | Safety Set (SAF) | LCZ696 (Sacubitril/Valsartan) | 2,820 | |
| Overall Study | Safety Set (SAF) | Ramipril | 2,816 | |
| Overall Study | COMPLETED | LCZ696 (Sacubitril/Valsartan) | 2,605 | |
| Overall Study | COMPLETED | Ramipril | 2,576 | |
| Overall Study | NOT COMPLETED | LCZ696 (Sacubitril/Valsartan) | 229 | |
| Overall Study | NOT COMPLETED | Ramipril | 259 |
Source ClinicalTrials.gov
Adverse events3,448
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LCZ696 Pre-treatment | 0 | 0 | |
| other | Anaemia | Blood and lymphatic system disorders | Ramipril Pre-treatment | 0 | 0 | |
| other | Anaemia | Blood and lymphatic system disorders | LCZ696 | 130 | 2,820 | |
| other | Anaemia | Blood and lymphatic system disorders | Ramipril | 123 | 2,816 | |
| other | Angina pectoris | Cardiac disorders | LCZ696 Pre-treatment | 0 | 0 | |
| other | Angina pectoris | Cardiac disorders | Ramipril Pre-treatment | 0 | 0 | |
| other | Angina pectoris | Cardiac disorders | LCZ696 | 125 | 2,820 | |
| other | Angina pectoris | Cardiac disorders | Ramipril | 140 | 2,816 | |
| other | Atrial fibrillation | Cardiac disorders | LCZ696 Pre-treatment | 0 | 0 | |
| other | Atrial fibrillation | Cardiac disorders | Ramipril Pre-treatment | 0 | 0 |
1 to 10 of 3,448Source ClinicalTrials.gov
See all 3,448 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 Pre-treatment | 1 | 2,834 |
| Total, all-cause mortality | Ramipril Pre-treatment | 3 | 2,835 |
| Total, all-cause mortality | LCZ696 | 220 | 2,820 |
| Total, all-cause mortality | Ramipril | 244 | 2,816 |
| Total, other adverse events | LCZ696 Pre-treatment | 0 | 0 |
| Total, other adverse events | Ramipril Pre-treatment | 0 | 0 |
| Total, other adverse events | LCZ696 | 1,769 | 2,820 |
| Total, other adverse events | Ramipril | 1,770 | 2,816 |
| Total, serious adverse events | LCZ696 Pre-treatment | 0 | 0 |
| Total, serious adverse events | Ramipril Pre-treatment | 0 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers10
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| LCZ696 (Sacubitril/Valsartan) vs Ramipril: Number of Participants With a Confirmed Composite of HF Hospitalization or Outpatient HF | Trial comparisons |
| LCZ696 (Sacubitril/Valsartan) vs Ramipril: Number of Participants With a Confirmed Composite of CV Death or HF Hospitalization | Trial comparisons |
| LCZ696 (Sacubitril/Valsartan) vs Ramipril: All-cause Mortality for Full Analysis Set (FAS) | Trial comparisons |
| LCZ696 (Sacubitril/Valsartan) vs Ramipril: Number of Participants With a Confirmed Composite of CV Death, Non-fatal Spontaneous Myocardial Infarction or Non-fatal Stroke | Trial comparisons |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT02924727
GET https://conductscience.org/api/trials/v1/NCT02924727/results?page=2