Trial · NCT01082874
PeriOperative ISchemic Evaluation-2 Trial
NCT01082874, Phase 3, Completed, Hamilton Health Sciences Corporation; results first posted 2016-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PeriOperative ISchemic Evaluation-2 Trial. Trials, record NCT01082874. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01082874
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PeriOperative ISchemic Evaluation-2 Trial
- NCT number
- NCT01082874
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10,010 participants, actual
- Lead sponsor
- Hamilton Health Sciences Corporation
- Conditions
- Cardiovascular Disease
- Interventions
- Active Clonidine, Placebo Clonidine, Active ASA, Placebo ASA
- First posted
- 2010-03-09
- Last updated
- 2016-08-25
- Other registries' IDs
- eudract:2009-018173-31
- Results first posted
- 2016-08-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite of All-cause Mortality and Nonfatal MI | 30 days | |
| Primary | All-cause Mortality and Nonfatal MI | 1 year | |
| Secondary | Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke | 30 days | |
| Secondary | Individual Secondary Outcomes | 30 days | All-cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, pulmonary emboli, deep venous thrombosis, clinically important atrial fibrillation, amputation, peripheral arterial thrombosis, infection/sepsis, rehospitalization for vascular reasons, length of hospital stay, length of intensive care unit / cardiac care unit (ICU/CCU) stay, and new acute renal failure requiring dialysis. |
| Secondary | Composite Outcome by ASA Stratum | 30 days | Composite outcome of all-cause mortality, nonfatal MI, cardiac revascularization procedure, nonfatal pulmonary emboli, and nonfatal deep venous thrombosis. |
| Secondary | Safety Outcomes in ASA Trial | 30 days | Stroke, congestive heart failure, life-threatening bleeding, and major bleeding. |
| Secondary | Safety Outcomes in Clonidine Trial | 30 days | Stroke, clinically important hypotension, clinically important bradycardia, and congestive heart failure. |
| Secondary | Composite Outcome at 1 Year | 1 year | All-cause mortality, nonfatal MI, and nonfatal stroke. |
| Secondary | Individual Secondary Outcomes at 1 Year | 1 year | All cause mortality, vascular mortality, MI, nonfatal cardiac arrest, cardiac revascularization procedure, stroke, pulmonary emboli, deep venous thrombosis, amputation, peripheral arterial thrombosis, new diagnosis of cancer, diagnosis of recurrent cancer and rehospitalization for vascular reason. |
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 | Composite of All-cause Mortality and Nonfatal MI | 30 days | participants | NUMBER | |
| PRIMARY | All-cause Mortality and Nonfatal MI | 1 year | |||
| SECONDARY | Composite of All-cause Mortality, Nonfatal MI, and Nonfatal Stroke | 30 days | |||
| SECONDARY | Individual Secondary Outcomes | 30 days | |||
| SECONDARY | Composite Outcome by ASA Stratum | 30 days | |||
| SECONDARY | Safety Outcomes in ASA Trial | 30 days | |||
| SECONDARY | Safety Outcomes in Clonidine Trial | 30 days | |||
| SECONDARY | Composite Outcome at 1 Year | 1 year | |||
| SECONDARY | Individual Secondary Outcomes at 1 Year | 1 year |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Composite of All-cause Mortality and Nonfatal MI | Active Clonidine and Active ASA | 173 | participants | ||
| Composite of All-cause Mortality and Nonfatal MI | Active Clonidine and Placebo ASA | 194 | participants | ||
| Composite of All-cause Mortality and Nonfatal MI | Placebo Clonidine and Active ASA | 178 | participants | ||
| Composite of All-cause Mortality and Nonfatal MI | Placebo Clonidine and Placebo ASA | 161 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active Clonidine and Active ASA | 2,499 | |
| Overall Study | STARTED | Active Clonidine and Placebo ASA | 2,510 | |
| Overall Study | STARTED | Placebo Clonidine and Active ASA | 2,499 | |
| Overall Study | STARTED | Placebo Clonidine and Placebo ASA | 2,502 | |
| Overall Study | COMPLETED | Active Clonidine and Active ASA | 2,488 | |
| Overall Study | COMPLETED | Active Clonidine and Placebo ASA | 2,498 | |
| Overall Study | COMPLETED | Placebo Clonidine and Active ASA | 2,488 | |
| Overall Study | COMPLETED | Placebo Clonidine and Placebo ASA | 2,489 | |
| Overall Study | NOT COMPLETED | Active Clonidine and Active ASA | 11 | |
| Overall Study | NOT COMPLETED | Active Clonidine and Placebo ASA | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events500
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 |
|---|---|---|---|---|---|---|
| serious | Anemia | Blood and lymphatic system disorders | Active Clonidine and Active ASA | 1 | 2,499 | 1 |
| serious | Anemia | Blood and lymphatic system disorders | Active Clonidine and Placebo ASA | 0 | 2,510 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Placebo Clonidine and Active ASA | 0 | 2,499 | 0 |
| serious | Anemia | Blood and lymphatic system disorders | Placebo Clonidine and Placebo ASA | 0 | 2,502 | 0 |
| serious | Dissemianted intravascular coagulation | Blood and lymphatic system disorders | Active Clonidine and Active ASA | 0 | 2,499 | 0 |
| serious | Dissemianted intravascular coagulation | Blood and lymphatic system disorders | Active Clonidine and Placebo ASA | 1 | 2,510 | 1 |
| serious | Dissemianted intravascular coagulation | Blood and lymphatic system disorders | Placebo Clonidine and Active ASA | 0 | 2,499 | 0 |
| serious | Dissemianted intravascular coagulation | Blood and lymphatic system disorders | Placebo Clonidine and Placebo ASA | 0 | 2,502 | 0 |
| serious | atrial fibrillation | Cardiac disorders | Active Clonidine and Active ASA | 0 | 2,499 | 0 |
| serious | atrial fibrillation | Cardiac disorders | Active Clonidine and Placebo ASA | 0 | 2,510 | 0 |
1 to 10 of 500Source ClinicalTrials.gov
See all 500 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Clonidine and Active ASA | ||
| Total, all-cause mortality | Active Clonidine and Placebo ASA | ||
| Total, all-cause mortality | Placebo Clonidine and Active ASA | ||
| Total, all-cause mortality | Placebo Clonidine and Placebo ASA | ||
| Total, other adverse events | Active Clonidine and Active ASA | 0 | 2,499 |
| Total, other adverse events | Active Clonidine and Placebo ASA | 0 | 2,510 |
| Total, other adverse events | Placebo Clonidine and Active ASA | 0 | 2,499 |
| Total, other adverse events | Placebo Clonidine and Placebo ASA | 0 | 2,502 |
| Total, serious adverse events | Active Clonidine and Active ASA | 46 | 2,499 |
| Total, serious adverse events | Active Clonidine and Placebo ASA | 52 | 2,510 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers11
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01082874
GET https://conductscience.org/api/trials/v1/NCT01082874/events?page=2