Trial · NCT00086450
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
NCT00086450, Phase 3, Unknown, Valentin Fuster; results first posted 2017-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM). Trials, record NCT00086450. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00086450
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)
- NCT number
- NCT00086450
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 1,900 participants, actual
- Lead sponsor
- Valentin Fuster
- Conditions
- Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Heart Diseases
- Interventions
- Coronary Artery Bypass Graft, Percutaneous Coronary Intervention
- First posted
- 2004-07-05
- Last updated
- 2017-02-06
- Results first posted
- 2017-02-06
- Limitations and caveats
- Since the trial was not blinded, patients may have been treated differently on the basis of their surgical procedure.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke | Measured at Year 5 | median 3.8 years of follow-up |
| Secondary | Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization | Measured at Year 1 | |
| Secondary | All-cause Mortality | Measured at Year 5 | |
| Secondary | Rates of Individual MACCE Endpoints | Measured at Day 30 | Major adverse cardiovascular and cerebrovascular events |
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 | 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke | Measured at Year 5 | percentage of participants | NUMBER | |
| SECONDARY | Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization | Measured at Year 1 | percentage of participants | NUMBER | |
| SECONDARY | All-cause Mortality | Measured at Year 5 | percentage of participants | NUMBER | |
| SECONDARY | Rates of Individual MACCE Endpoints | Measured at Day 30 | 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 |
|---|---|---|---|---|---|
| 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke | Percutaneous Coronary Intervention | 26.6 | percentage of participants | ||
| 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke | Coronary Artery Bypass Graft | 18.7 | percentage of participants | ||
| Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization | Percutaneous Coronary Intervention | 16.8 | percentage of participants | ||
| Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization | Coronary Artery Bypass Graft | 11.8 | percentage of participants | ||
| All-cause Mortality | Percutaneous Coronary Intervention | 16.3 | percentage of participants | ||
| All-cause Mortality | Coronary Artery Bypass Graft | 10.9 | percentage of participants | ||
| Rates of Individual MACCE Endpoints | Percutaneous Coronary Intervention | 4.8 | percentage of participants | ||
| Rates of Individual MACCE Endpoints | Coronary Artery Bypass Graft | 5.2 | 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 | Percutaneous Coronary Intervention | 953 | |
| Overall Study | STARTED | Coronary Artery Bypass Graft | 947 | |
| Overall Study | COMPLETED | Percutaneous Coronary Intervention | 953 | |
| Overall Study | COMPLETED | Coronary Artery Bypass Graft | 947 | |
| Overall Study | NOT COMPLETED | Percutaneous Coronary Intervention | 0 | |
| Overall Study | NOT COMPLETED | Coronary Artery Bypass Graft | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Renal insufficiency | Renal and urinary disorders | Percutaneous Coronary Intervention | 44 | 953 | 44 |
| other | Renal insufficiency | Renal and urinary disorders | Coronary Artery Bypass Graft | 37 | 947 | 37 |
| serious | Major bleeding | Blood and lymphatic system disorders | Percutaneous Coronary Intervention | 23 | 953 | 23 |
| serious | Major bleeding | Blood and lymphatic system disorders | Coronary Artery Bypass Graft | 34 | 947 | 34 |
| serious | Acute Renal Failure | Renal and urinary disorders | Percutaneous Coronary Intervention | 1 | 953 | 1 |
| serious | Acute Renal Failure | Renal and urinary disorders | Coronary Artery Bypass Graft | 8 | 947 | 8 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Percutaneous Coronary Intervention | ||
| Total, all-cause mortality | Coronary Artery Bypass Graft | ||
| Total, other adverse events | Percutaneous Coronary Intervention | 44 | 953 |
| Total, other adverse events | Coronary Artery Bypass Graft | 37 | 947 |
| Total, serious adverse events | Percutaneous Coronary Intervention | 24 | 953 |
| Total, serious adverse events | Coronary Artery Bypass Graft | 42 | 947 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants1
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 |
|---|---|---|---|---|---|
| U01HL071988 | Coronary Revascularization in Diabetic Patients | FUSTER, VALENTIN | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2011 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Percutaneous Coronary Intervention vs Coronary Artery Bypass Graft: 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/NCT00086450
GET https://conductscience.org/api/trials/v1/NCT00086450/registered