Trial · NCT02596126
Secondary Prevention of Cardiovascular Disease in the Elderly Trial
NCT02596126, Phase 3, Completed, Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III; results first posted 2025-05-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Secondary Prevention of Cardiovascular Disease in the Elderly Trial. Trials, record NCT02596126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02596126
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Secondary Prevention of Cardiovascular Disease in the Elderly Trial
- NCT number
- NCT02596126
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,499 participants, actual
- Lead sponsor
- Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III
- Conditions
- Myocardial Infarction, Cardiovascular Disease
- Interventions
- Cardiovascular Polypill, Treatment Prevention for Secondary CV
- First posted
- 2015-11-04
- Last updated
- 2025-05-23
- Other registries' IDs
- eudract:2015-002868-17
- Results first posted
- 2025-05-23
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major Cardiovascular Adverse Events (MACE) | Up to 5 years | The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: * Cardiovascular death. * Any nonfatal type 1 myocardial infarction. * Any nonfatal ischemic stroke. * Any urgent coronary revascularization not resulting in death. |
| Secondary | Efficacy Endpoints | 6 months | Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. |
| Secondary | Safety Endpoints | Up to 5 Years | All-cause mortality. |
| Secondary | Efficacy Endpoints | 2 years | Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 6 months | The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 12 months | The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 2 years | The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 6 months | The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 12 months | The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group. |
| Secondary | Efficacy Endpoints | 2 years | The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Major Cardiovascular Adverse Events (MACE) | Up to 5 years | number of adjudicated events | NUMBER | |
| SECONDARY | Efficacy Endpoints | 6 months | percentage of participants | NUMBER | |
| SECONDARY | Safety Endpoints | Up to 5 Years | number of events | NUMBER | |
| SECONDARY | Efficacy Endpoints | 2 years | percentage of participants | NUMBER | |
| SECONDARY | Efficacy Endpoints | 6 months | millimeters of mercury (mmHg) | MEAN | |
| SECONDARY | Efficacy Endpoints | 12 months | millimeters of mercury (mmHg) | MEAN | |
| SECONDARY | Efficacy Endpoints | 2 years | millimeters of mercury (mmHg) | MEAN | |
| SECONDARY | Efficacy Endpoints | 6 months | millimeters of mercury (mmHg) | MEAN | |
| SECONDARY | Efficacy Endpoints | 12 months | millimeters of mercury (mmHg) | MEAN | |
| SECONDARY | Efficacy Endpoints | 2 years | millimeters of mercury (mmHg) | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Major Cardiovascular Adverse Events (MACE) | Treatment Prevention for Secondary CV | 156 | number of adjudicated events | ||
| Major Cardiovascular Adverse Events (MACE) | Cardiovascular Polypill | 118 | number of adjudicated events | ||
| Efficacy Endpoints | Treatment Prevention for Secondary CV | Low adherence (0-5) | 9.5 | percentage of participants | |
| Efficacy Endpoints | Cardiovascular Polypill | Low adherence (0-5) | 5.5 | percentage of participants | |
| Efficacy Endpoints | Treatment Prevention for Secondary CV | Medium adherence (6-7) | 27.8 | percentage of participants | |
| Efficacy Endpoints | Cardiovascular Polypill | Medium adherence (6-7) | 24.0 | percentage of participants | |
| Efficacy Endpoints | Treatment Prevention for Secondary CV | High adherence (8) | 62.7 | percentage of participants | |
| Efficacy Endpoints | Cardiovascular Polypill | High adherence (8) | 70.6 | percentage of participants | |
| Safety Endpoints | Treatment Prevention for Secondary CV | 117 | number of events | ||
| Safety Endpoints | Cardiovascular Polypill | 115 | number of events |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Prevention for Secondary CV | 1,241 | |
| Overall Study | STARTED | Cardiovascular Polypill | 1,258 | |
| Overall Study | COMPLETED | Treatment Prevention for Secondary CV | 1,222 | |
| Overall Study | COMPLETED | Cardiovascular Polypill | 1,228 | |
| Overall Study | NOT COMPLETED | Treatment Prevention for Secondary CV | 19 | |
| Overall Study | NOT COMPLETED | Cardiovascular Polypill | 30 |
Source ClinicalTrials.gov
Adverse events1,440
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 | Treatment Prevention for Secondary CV | 13 | 1,229 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Cardiovascular Polypill | 12 | 1,237 | 13 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Treatment Prevention for Secondary CV | 1 | 1,229 | 1 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Cardiovascular Polypill | 0 | 1,237 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Treatment Prevention for Secondary CV | 1 | 1,229 | 1 |
| other | Eosinophilia | Blood and lymphatic system disorders | Cardiovascular Polypill | 0 | 1,237 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Treatment Prevention for Secondary CV | 1 | 1,229 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Cardiovascular Polypill | 2 | 1,237 | 2 |
| other | Leukocytosis | Blood and lymphatic system disorders | Treatment Prevention for Secondary CV | 1 | 1,229 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Cardiovascular Polypill | 0 | 1,237 | 0 |
1 to 10 of 1,440Source ClinicalTrials.gov
See all 1,440 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Prevention for Secondary CV | 117 | 1,229 |
| Total, all-cause mortality | Cardiovascular Polypill | 115 | 1,237 |
| Total, other adverse events | Treatment Prevention for Secondary CV | 388 | 1,229 |
| Total, other adverse events | Cardiovascular Polypill | 404 | 1,237 |
| Total, serious adverse events | Treatment Prevention for Secondary CV | 220 | 1,229 |
| Total, serious adverse events | Cardiovascular Polypill | 248 | 1,237 |
Source ClinicalTrials.gov
Papers2
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Prevention for Secondary CV vs Cardiovascular Polypill: deaths from any cause | Trial comparisons |
| Treatment Prevention for Secondary CV vs Cardiovascular Polypill: 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/NCT02596126
GET https://conductscience.org/api/trials/v1/NCT02596126/registered?page=2