Trial · NCT00872001
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
NCT00872001, Phase 3, Terminated, Merck Sharp & Dohme LLC; results first posted 2012-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED). Trials, record NCT00872001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00872001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
- NCT number
- NCT00872001
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 3,080 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Coronary Artery Bypass, Myocardial Infarction, Ventricular Dysfunction, Left, Stroke, Cardiopulmonary Bypass
- Interventions
- Acadesine, Normal Saline
- First posted
- 2009-03-30
- Last updated
- 2015-10-29
- Results first posted
- 2012-12-20
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Up to Post-Operative Day 28 | Incidence of all-cause death, non-fatal stroke, or need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: All-cause death: Death from any cause, Non-fatal Stoke: occurrence of a stoke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. |
| Secondary | Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Up to Post-Operative Day 28 | Incidence of cardiovascular death, non-fatal stroke, and need for mechanical support for SLVD (any component and composite) through post-operative Day 28 during and following CABG and administration of acadesine or placebo. Components defined as follows: Cardiovascular death: Death due to cardiovascular causes, Non-fatal Stroke: occurrence of a stroke that was confirmed and adjudicated by Clinical Endpoints Committee that did not result in death, and Mechanical Support for SLVD: New use of any mechanical support for ≥1 hour for treatment of low cardiac output. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Up to Post-Operative Day 28 | The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite. | Percentage of Participants | NUMBER |
| SECONDARY | Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Up to Post-Operative Day 28 | The Intent-to-Treat Population included all participants randomly assigned to a treatment group and did not have to receive study drug. Each participant contributed to no more than one efficacy endpoint in any composite, i.e., a participant who experienced multiple components of an endpoint composite was counted only once in that composite. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Acadesine | Composite of All Events | 4.9 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Placebo | Composite of All Events | 4.9 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Acadesine | All-Cause Death | 1.9 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Placebo | All-Cause Death | 1.7 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Acadesine | Non-Fatal Stroke | 1.7 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Placebo | Non-Fatal Stroke | 1.7 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Acadesine | Need for Mechanical Support for SLVD | 2.2 | Percentage of Participants | |
| Incidence of All-cause Death, Non-fatal Stroke, and Need for Mechanical Support for Severe Left Ventricular Dysfunction (SLVD) (Intent-to-Treat Population) | Placebo | Need for Mechanical Support for SLVD | 2.3 | Percentage of Participants | |
| Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Acadesine | Composite of All Events | 4.8 | Percentage of Participants | |
| Incidence of Cardiovascular Death, Non-fatal Stroke, and Need for Mechanical Support for SLVD (Intent-to-Treat Population) | Placebo (Normal Saline) | Composite of All Events | 4.7 | Percentage of Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acadesine | 1,536 | |
| Overall Study | STARTED | Placebo (Normal Saline) | 1,544 | |
| Overall Study | COMPLETED | Acadesine | 1,400 | |
| Overall Study | COMPLETED | Placebo (Normal Saline) | 1,413 | |
| Overall Study | NOT COMPLETED | Acadesine | 136 | |
| Overall Study | NOT COMPLETED | Placebo (Normal Saline) | 131 |
Source ClinicalTrials.gov
Adverse events550
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 | Acadesine | 384 | 1,442 | 388 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (Normal Saline) | 383 | 1,457 | 387 |
| other | Leukocytosis | Blood and lymphatic system disorders | Acadesine | 114 | 1,442 | 117 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo (Normal Saline) | 95 | 1,457 | 95 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Acadesine | 119 | 1,442 | 123 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (Normal Saline) | 129 | 1,457 | 129 |
| other | Atrial Fibrillation | Cardiac disorders | Acadesine | 290 | 1,442 | 303 |
| other | Atrial Fibrillation | Cardiac disorders | Placebo (Normal Saline) | 328 | 1,457 | 346 |
| other | Sinus Tachycardia | Cardiac disorders | Acadesine | 81 | 1,442 | 82 |
| other | Sinus Tachycardia | Cardiac disorders | Placebo (Normal Saline) | 67 | 1,457 | 67 |
1 to 10 of 550Source ClinicalTrials.gov
See all 550 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acadesine | ||
| Total, all-cause mortality | Placebo (Normal Saline) | ||
| Total, other adverse events | Acadesine | 1,154 | 1,442 |
| Total, other adverse events | Placebo (Normal Saline) | 1,189 | 1,457 |
| Total, serious adverse events | Acadesine | 327 | 1,442 |
| Total, serious adverse events | Placebo (Normal Saline) | 329 | 1,457 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Acadesine vs Placebo (Normal Saline): 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/NCT00872001
GET https://conductscience.org/api/trials/v1/NCT00872001/events?page=2