Trial · NCT00501059
A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
NCT00501059, Phase 3, Completed, Bayer; results first posted 2018-01-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease. Trials, record NCT00501059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00501059
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of Enteric-Coated Acetylsalicylic Acid in Patients at Moderate Risk of Cardiovascular Disease
- NCT number
- NCT00501059
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 12,546 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Moderate Risk of CVD
- Interventions
- Aspirin (Acetylsalicylic acid, BAYE4465), Placebo
- First posted
- 2007-07-13
- Last updated
- 2018-10-26
- Other registries' IDs
- eudract:2006-003622-29
- Results first posted
- 2018-01-08
- Limitations and caveats
The reported analyses are limited to endpoint events that met strict criteria. Further blinded review of events is ongoing to identify endpoints based on pragmatic criteria. Interpretations for clinical decision making should await future reporting.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Until follow-up (approximate 6 years) | The primary efficacy endpoint was a composite outcome consisting of the first occurrence of confirmed MI, stroke, cardiovascular death, UA, TIA. The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. |
| Secondary | Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) | Until follow-up (approximate 6 years) | The time to Composite outcome consisting of the first occurrence of cardiovascular death, MI, or stroke (ischemic, hemorrhagic, or unknown) was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. |
| Secondary | Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA | Until follow-up (approximately 6 years) | The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. |
| Secondary | Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer | Until follow-up (approximately 6 years) | The time to event was defined as the number of days from the date of randomization to the date of the event confirmed by adjudication. The numbers of days for milestones when 1%, 2%, 3% and 4% of the subjects have reached endpoint events were estimated from Kaplan-Meier-Analyses. |
| Secondary | Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer | Until follow-up (approximately 6 years) | |
| Secondary | Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately | Until follow-up (approximately 6 years) | The percentages of subjects with the efficacy endpoints of confirmed MI, stroke, cardiovascular death, UA and TIA are reported separately. \*all other CV death without fatal MI and fatal stroke |
| Other | Number of Subjects With Adjudicated GI Bleeding by Severity | Until follow-up (approximate 6 years) | |
| Other | Incidence of Composite Outcomes and Non-fatal MI | Until follow-up (approximate 6 years) | |
| Other | Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population | Until follow-up (approximate 6 years) | \*all other CV death without fatal MI and fatal stroke. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Until follow-up (approximate 6 years) | Intention-to-treat. The intent-to-treat (ITT) group (N=12546) consists of all patients who were randomized to the assigned study drug. | Days | COUNT_OF_UNITS |
| SECONDARY | Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) | Until follow-up (approximate 6 years) | ITT | Days | COUNT_OF_UNITS |
| SECONDARY | Time to the First Occurrence of the Individual Components of the Primary: Non-fatal MI, Total MI, Non-fatal Stroke, Total Stroke, Cardiovascular Death, UA and TIA | Until follow-up (approximately 6 years) | ITT | Days | COUNT_OF_UNITS |
| SECONDARY | Time to All-cause Mortality, the First Occurrence of All Cancers Excluding Non-melanoma Skin Cancer (NMSC) and the First Occurrence of Colon Cancer | Until follow-up (approximately 6 years) | ITT | Days | COUNT_OF_UNITS |
| SECONDARY | Incidence of All-cause Mortality, All Cancers Excluding Non-melanoma Skin Cancer and Colon Cancer | Until follow-up (approximately 6 years) | ITT | Percentage of participants | NUMBER |
| SECONDARY | Incidence of Confirmed MI, Stroke, Cardiovascular Death, UA, and TIA Separately | Until follow-up (approximately 6 years) | ITT | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects With Adjudicated GI Bleeding by Severity | Until follow-up (approximate 6 years) | ITT | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Incidence of Composite Outcomes and Non-fatal MI | Until follow-up (approximate 6 years) | ITT | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Incidence of Composite Outcomes and Individual Outcomes in Per-protocol Population | Until follow-up (approximate 6 years) | Per-protocol (PP) group (N=7702) consists of all patients who had no protocol violation. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Acetylsalicylic Acid (Aspirin, BAYE4465) | Days until 1% subjects had an efficacy event | 528 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Placebo | Days until 1% subjects had an efficacy event | 381 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Acetylsalicylic Acid (Aspirin, BAYE4465) | Days until 2% subjects had an efficacy event | 889 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Placebo | Days until 2% subjects had an efficacy event | 796 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Acetylsalicylic Acid (Aspirin, BAYE4465) | Days until 3% subjects had an efficacy event | 1225 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Placebo | Days until 3% subjects had an efficacy event | 1134 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Acetylsalicylic Acid (Aspirin, BAYE4465) | Days until 4% subjects had an efficacy event | 1630 | Days | |
| Time to the First Occurrence of the Composite Outcome of MI (Myocardial Infarction), Stroke, Cardiovascular Death, UA (Unstable Angina) or TIA (Transient Ischemic Attack) | Placebo | Days until 4% subjects had an efficacy event | 1582 | Days | |
| Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) | Acetylsalicylic Acid (Aspirin, BAYE4465) | Days until 1% subjects had an efficacy event | 678 | Days | |
| Time to the First Occurrence of the Composite Outcome of Cardiovascular Death, MI, or Stroke (Ischemic, Hemorrhagic, or Unknown) | Placebo | Days until 1% subjects had an efficacy event | 522 | Days |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetylsalicylic Acid (Aspirin, BAYE4465) | 6,270 | |
| Overall Study | STARTED | Placebo | 6,276 | |
| Overall Study | COMPLETED | Acetylsalicylic Acid (Aspirin, BAYE4465) | 4,402 | |
| Overall Study | COMPLETED | Placebo | 4,384 | |
| Overall Study | NOT COMPLETED | Acetylsalicylic Acid (Aspirin, BAYE4465) | 1,868 | |
| Overall Study | NOT COMPLETED | Placebo | 1,892 |
Source ClinicalTrials.gov
Adverse events2,008
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 653 | 6,276 | 803 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Acetylsalicylic Acid | 636 | 6,270 | 816 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 688 | 6,276 | 908 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Acetylsalicylic Acid | 695 | 6,270 | 897 |
| other | Bronchitis | Infections and infestations | Placebo | 482 | 6,276 | 680 |
| other | Bronchitis | Infections and infestations | Acetylsalicylic Acid | 514 | 6,270 | 741 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo | 497 | 6,276 | 601 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Acetylsalicylic Acid | 442 | 6,270 | 556 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo | 362 | 6,276 | 419 |
| other | Dyspepsia | Gastrointestinal disorders | Acetylsalicylic Acid | 374 | 6,270 | 446 |
1 to 10 of 2,008Source ClinicalTrials.gov
See all 2,008 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Acetylsalicylic Acid | ||
| Total, other adverse events | Placebo | 5,053 | 6,276 |
| Total, other adverse events | Acetylsalicylic Acid | 5,059 | 6,270 |
| Total, serious adverse events | Placebo | 1,311 | 6,276 |
| Total, serious adverse events | Acetylsalicylic Acid | 1,266 | 6,270 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30158069 | RESULT |
Source PubMed
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 |
|---|
| Acetylsalicylic Acid vs Placebo: 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/NCT00501059
GET https://conductscience.org/api/trials/v1/NCT00501059/results?page=2