Trial · NCT00120289
Niacin Plus Statin to Prevent Vascular Events
NCT00120289, Phase 3, Terminated, Axio Research. LLC; results first posted 2015-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Niacin Plus Statin to Prevent Vascular Events. Trials, record NCT00120289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00120289
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Niacin Plus Statin to Prevent Vascular Events
- NCT number
- NCT00120289
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,414 participants, actual
- Lead sponsor
- Axio Research. LLC
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Coronary Disease, Atherosclerosis, Myocardial Infarction
- Interventions
- Extended release niacin, Simvastatin
- First posted
- 2005-07-15
- Last updated
- 2016-04-06
- Results first posted
- 2015-06-17
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months. | |
| Secondary | Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months | |
| Secondary | Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months | |
| Secondary | Cardiovascular Mortality | Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months. |
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 | Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months. | Intention-to-treat | participants | NUMBER |
| SECONDARY | Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months | participants | NUMBER | |
| SECONDARY | Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke | Time to first event measured from date of randomization through last follow-up visit (common termination) for an average of 36 months follow-up, maximum 66 months | Intention to treat | participants | NUMBER |
| SECONDARY | Cardiovascular Mortality | Time to first event measured from date of randomization through last follow-up visit (common termination), for an average of 36 months follow-up, maximum 66 months. | Intention to treat | 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 |
|---|---|---|---|---|---|
| Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization | ERN + Simvastatin | 282 | participants | ||
| Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization | Placebo + Simvastatin | 274 | participants | ||
| Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke | ERN + Simvastatin | 171 | participants | ||
| Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke | Placebo + Simvastatin | 158 | participants | ||
| Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke | ERN + Simvastatin | 156 | participants | ||
| Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke | Placebo + Simvastatin | 138 | participants | ||
| Cardiovascular Mortality | ERN + Simvastatin | 45 | participants | ||
| Cardiovascular Mortality | Placebo + Simvastatin | 38 | 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 | ERN + Simvastatin | 1,718 | |
| Overall Study | STARTED | Placebo + Simvastatin | 1,696 | |
| Overall Study | COMPLETED | ERN + Simvastatin | 1,597 | |
| Overall Study | COMPLETED | Placebo + Simvastatin | 1,587 | |
| Overall Study | NOT COMPLETED | ERN + Simvastatin | 121 | |
| Overall Study | NOT COMPLETED | Placebo + Simvastatin | 109 |
Source ClinicalTrials.gov
Adverse events1,414
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 | ERN + Simvastatin | 41 | 1,718 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Simvastatin | 34 | 1,696 | |
| other | Angina pectoris | Cardiac disorders | ERN + Simvastatin | 43 | 1,718 | |
| other | Angina pectoris | Cardiac disorders | Placebo + Simvastatin | 46 | 1,696 | |
| other | Atrial fibrillation | Cardiac disorders | ERN + Simvastatin | 43 | 1,718 | |
| other | Atrial fibrillation | Cardiac disorders | Placebo + Simvastatin | 30 | 1,696 | |
| other | Chest pain | Cardiac disorders | ERN + Simvastatin | 112 | 1,718 | |
| other | Chest pain | Cardiac disorders | Placebo + Simvastatin | 95 | 1,696 | |
| other | Dyspnoea | Cardiac disorders | ERN + Simvastatin | 89 | 1,718 | |
| other | Dyspnoea | Cardiac disorders | Placebo + Simvastatin | 89 | 1,696 |
1 to 10 of 1,414Source ClinicalTrials.gov
See all 1,414 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ERN + Simvastatin | ||
| Total, all-cause mortality | Placebo + Simvastatin | ||
| Total, other adverse events | ERN + Simvastatin | 1,413 | 1,718 |
| Total, other adverse events | Placebo + Simvastatin | 1,345 | 1,696 |
| Total, serious adverse events | ERN + Simvastatin | 587 | 1,718 |
| Total, serious adverse events | Placebo + Simvastatin | 551 | 1,696 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HL081616 | AIM HIGH: Niacin Plus Statin to Prevent Vascular Events | PROBSTFIELD, JEFFREY LYNN | UNIVERSITY OF WASHINGTON | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2010 | NIH RePORTER |
| U01HL081649 | AIM-HIGH | MCBRIDE, RUTH M | AXIO RESEARCH, LLC | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2010 | NIH RePORTER |
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
ERN + Simvastatin vs Placebo + Simvastatin: Composite End Point of CHD Death, Nonfatal MI, Ischemic Stroke, Hospitalization for Non-ST Segment Elevation Acute Coronary Syndrome (ACS), or Symptom-driven Coronary or Cerebral Revascularization | Trial comparisons |
| ERN + Simvastatin vs Placebo + Simvastatin: Cardiovascular Mortality | Trial comparisons |
| ERN + Simvastatin vs Placebo + Simvastatin: Composite Endpoint of CHD Death, Non-fatal MI, High-risk ACS or Ischemic Stroke | Trial comparisons |
| ERN + Simvastatin vs Placebo + Simvastatin: Composite Endpoint of CHD Death, Non-fatal MI, or Ischemic Stroke | Trial comparisons |
| ERN + Simvastatin vs Placebo + Simvastatin: serious adverse events | 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/NCT00120289
GET https://conductscience.org/api/trials/v1/NCT00120289/events?page=2