Trial · NCT00202878
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
NCT00202878, Phase 3, Completed, Organon and Co; results first posted 2015-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103). Trials, record NCT00202878. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00202878
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
- NCT number
- NCT00202878
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 18,144 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypercholesterolemia, Myocardial Infarction
- Interventions
- ezetimibe/simvastatin, simvastatin, Placebo for simvastatin 40 mg, Placebo for ezetimibe 10 mg/simvastatin 40 mg combination
- First posted
- 2005-09-20
- Last updated
- 2024-06-18
- Results first posted
- 2015-09-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death, major coronary Event (non-fatal myocardial infarction \[MI\], documented unstable angina \[UA\] requiring hospitalization, or coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) ≥ 30 days after randomization), or non-fatal Stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced cardiovascular death, major coronary event, or non-fatal stroke within 7 years from randomization. |
| Secondary | Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization. |
| Secondary | Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization. |
| Secondary | Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | All participants who were randomly assigned to a treatment arm. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | All participants who were randomly assigned to a treatment arm. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | All participants who were randomly assigned to a treatment arm. | Percentage of Participants | NUMBER |
| SECONDARY | Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Up to approximately 9 years | All participants who were randomly assigned to a treatment arm. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Ezetimibe/Simvastatin | 32.72 | 95% Confidence Interval 31.63 to 33.85 | Percentage of Participants | |
| Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Simvastatin | 34.67 | 95% Confidence Interval 33.56 to 35.81 | Percentage of Participants | |
| Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Ezetimibe/Simvastatin | 38.65 | 95% Confidence Interval 37.52 to 39.81 | Percentage of Participants | |
| Time to First Occurrence of Death From Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Simvastatin | 40.25 | 95% Confidence Interval 39.11 to 41.41 | Percentage of Participants | |
Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Ezetimibe/Simvastatin | 17.52 | 95% Confidence Interval 16.62 to 18.46 | Percentage of Participants | |
Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization With PCI or CABG ≥ 30 Days After Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Simvastatin | 18.88 | 95% Confidence Interval 17.96 to 19.83 | Percentage of Participants | |
Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Ezetimibe/Simvastatin | 34.49 | 95% Confidence Interval 33.38 to 35.63 | Percentage of Participants | |
Time to First Occurrence of CV Death, Nonfatal MI, UA With Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event) | Simvastatin | 36.20 | 95% Confidence Interval 35.07 to 37.34 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ezetimibe/Simvastatin | 9,067 | |
| Overall Study | STARTED | Simvastatin | 9,077 | |
| Overall Study | COMPLETED | Ezetimibe/Simvastatin | 6,868 | |
| Overall Study | COMPLETED | Simvastatin | 6,860 | |
| Overall Study | NOT COMPLETED | Ezetimibe/Simvastatin | 2,199 | |
| Overall Study | NOT COMPLETED | Simvastatin | 2,217 |
Source ClinicalTrials.gov
Adverse events3,662
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 | Diarrhoea | Gastrointestinal disorders | Ezetimide/Simvastatin | 540 | 9,067 | 540 |
| other | Diarrhoea | Gastrointestinal disorders | Simvastatin | 552 | 9,077 | 552 |
| other | Chest Pain | General disorders | Ezetimide/Simvastatin | 694 | 9,067 | 694 |
| other | Chest Pain | General disorders | Simvastatin | 731 | 9,077 | 731 |
| other | Fatigue | General disorders | Ezetimide/Simvastatin | 720 | 9,067 | 720 |
| other | Fatigue | General disorders | Simvastatin | 756 | 9,077 | 756 |
| other | Non-Cardiac Chest Pain | General disorders | Ezetimide/Simvastatin | 554 | 9,067 | 554 |
| other | Non-Cardiac Chest Pain | General disorders | Simvastatin | 543 | 9,077 | 543 |
| other | Oedema Peripheral | General disorders | Ezetimide/Simvastatin | 520 | 9,067 | 520 |
| other | Oedema Peripheral | General disorders | Simvastatin | 551 | 9,077 | 551 |
1 to 10 of 3,662Source ClinicalTrials.gov
See all 3,662 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ezetimide/Simvastatin | ||
| Total, all-cause mortality | Simvastatin | ||
| Total, other adverse events | Ezetimide/Simvastatin | 5,486 | 9,067 |
| Total, other adverse events | Simvastatin | 5,472 | 9,077 |
| Total, serious adverse events | Ezetimide/Simvastatin | 3,640 | 9,067 |
| Total, serious adverse events | Simvastatin | 3,649 | 9,077 |
Source ClinicalTrials.gov
Papers27
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ezetimide/Simvastatin vs Simvastatin: serious adverse events |
Source 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.
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/NCT00202878
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