Trial · NCT01594333
Cardiovascular Inflammation Reduction Trial
NCT01594333, Phase 3, Completed, Brigham and Women's Hospital; results first posted 2020-07-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cardiovascular Inflammation Reduction Trial. Trials, record NCT01594333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594333
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cardiovascular Inflammation Reduction Trial
- NCT number
- NCT01594333
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,786 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Cardiovascular Disease
- Interventions
- Methotrexate, Placebo
- First posted
- 2012-05-09
- Last updated
- 2020-07-24
- Results first posted
- 2020-07-24
- Limitations and caveats
The trial was terminated early because the pre-specified boundary for futility was crossed for both the original and the final primary endpoints and because of the lack of evidence of a reduction in hsCRP level with methotrexate treatment.
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Major Adverse Cardiovascular Events | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | The first occurrence of Major Adverse Cardiovascular Event which is defined as the occurrence of one or more of the following: Cardiovascular Death, Non-Fatal Myocardial Infarction or Non-Fatal Stroke. |
| Primary | Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization | From randomization to trial end (April 2, 2018) - up to a maximum of 5 years | The first occurrence of Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina that led to Urgent Coronary Revascularization. |
| Secondary | Number of Subjects With All-cause Mortality | From randomization to the trial end (April 2, 2018) up to a maximum of 5 years | Subjects who died from any cause. |
| Secondary | Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization | From randomization to the trial end (April 2, 2018) - up to a maximum of 5 years | The first occurrence of Major Adverse Cardiovascular Event or Any Coronary Revascularization. |
| Secondary | Number of Subjects With Hospitalization for Congestive Heart Failure | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | The first occurrence of Hospitalization for Congestive Heart Failure |
| Secondary | Number of Subjects With Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | The first occurrence of Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality. |
| Secondary | Number of Subjects With New Onset Type 2 Diabetes | From randomization to the trial end (April 2, 2018) - up to 5 years | New onset type 2 diabetes among those without diabetes at baseline. Baseline diabetes is defined as any of the following prior to randomization: clinician report of diabetes, use of antidiabetic medication, hbA1c \>=6.5 or fasting plasma glucose \>=126. |
| Other | Number of Subjects With Hospitalization for Unstable Angina That Led to Unplanned Coronary Revascularization | From randomization to the trial end (April 2, 2018) up to 5 years | The first occurrence of hospitalization for unstable angina that led to unplanned coronary revascularization |
| Other | Number of Subjects With Coronary Revascularization | From randomization to trial end (April 2, 2018) up to 5 years | The first occurrence of coronary revascularization |
| Other | Number of Subjects With Peripheral Artery Disease | From randomization to the trial end (April 2, 2018) - up to 5 years | The first occurrence of new or worsening of peripheral artery disease |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Major Adverse Cardiovascular Events | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | All randomized subjects | participants | NUMBER |
| PRIMARY | Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization | From randomization to trial end (April 2, 2018) - up to a maximum of 5 years | All randomized participants | participants | NUMBER |
| SECONDARY | Number of Subjects With All-cause Mortality | From randomization to the trial end (April 2, 2018) up to a maximum of 5 years | All Randomized Participants | participants | NUMBER |
| SECONDARY | Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization | From randomization to the trial end (April 2, 2018) - up to a maximum of 5 years | All randomized participants | participants | NUMBER |
| SECONDARY | Number of Subjects With Hospitalization for Congestive Heart Failure | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | All randomized participants | participants | NUMBER |
| SECONDARY | Number of Subjects With Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality | From randomization to trial end (April 2, 2018) up to a maximum of 5 years | All randomized participants | participants | NUMBER |
| SECONDARY | Number of Subjects With New Onset Type 2 Diabetes | From randomization to the trial end (April 2, 2018) - up to 5 years | Randomized participants without pre-randomization diabetes | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Subjects With Hospitalization for Unstable Angina That Led to Unplanned Coronary Revascularization | From randomization to the trial end (April 2, 2018) up to 5 years | All randomized participants | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects With Coronary Revascularization | From randomization to trial end (April 2, 2018) up to 5 years | All randomized participants | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Subjects With Peripheral Artery Disease | From randomization to the trial end (April 2, 2018) - up to 5 years |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Major Adverse Cardiovascular Events | Methotrexate | 170 | participants | ||
| Number of Subjects With Major Adverse Cardiovascular Events | Placebo | 167 | participants | ||
| Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization | Methotrexate | 201 | participants | ||
| Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization | Placebo | 207 | participants | ||
| Number of Subjects With All-cause Mortality | Methotrexate | 96 | participants | ||
| Number of Subjects With All-cause Mortality | Placebo | 83 | participants | ||
| Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization | Methotrexate | 278 | participants | ||
| Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization | Placebo | 288 | participants | ||
| Number of Subjects With Hospitalization for Congestive Heart Failure | Methotrexate | 48 | participants | ||
| Number of Subjects With Hospitalization for Congestive Heart Failure | Placebo | 53 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Methotrexate | 2,391 | |
| Overall Study | STARTED | Placebo | 2,395 | |
| Overall Study | COMPLETED | Methotrexate | 2,230 | |
| Overall Study | COMPLETED | Placebo | 2,244 | |
| Overall Study | NOT COMPLETED | Methotrexate | 161 | |
| Overall Study | NOT COMPLETED | Placebo | 151 |
Source ClinicalTrials.gov
Adverse events1,090
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 | Any | Infections and infestations | Methotrexate | 659 | 2,391 | |
| other | Any | Infections and infestations | Placebo | 584 | 2,395 | |
| other | Any | Gastrointestinal disorders | Methotrexate | 350 | 2,391 | |
| other | Any | Gastrointestinal disorders | Placebo | 284 | 2,395 | |
| other | Any | Blood and lymphatic system disorders | Methotrexate | 340 | 2,391 | |
| other | Any | Blood and lymphatic system disorders | Placebo | 244 | 2,395 | |
| other | Any | General disorders | Methotrexate | 279 | 2,391 | |
| other | Any | General disorders | Placebo | 254 | 2,395 | |
| other | Any | Respiratory, thoracic and mediastinal disorders | Methotrexate | 279 | 2,391 | |
| other | Any | Respiratory, thoracic and mediastinal disorders | Placebo | 210 | 2,395 |
1 to 10 of 1,090Source ClinicalTrials.gov
See all 1,090 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Methotrexate | 96 | 2,391 |
| Total, all-cause mortality | Placebo | 83 | 2,395 |
| Total, other adverse events | Methotrexate | 1,488 | 2,391 |
| Total, other adverse events | Placebo | 1,399 | 2,395 |
| Total, serious adverse events | Methotrexate | 569 | 2,391 |
| Total, serious adverse events | Placebo | 549 | 2,395 |
Source ClinicalTrials.gov
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| U01HL101422 | Cardiovascular Inflammation Reduction Trial (CIRT) | RIDKER, PAUL M. | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2018 | NIH RePORTER |
| U01HL101389 | Cardiovascular Inflammation Reduction Trial (CIRT): DCC | GLYNN, ROBERT J | BRIGHAM AND WOMEN'S HOSPITAL | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2011 to 2016 | NIH RePORTER |
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Methotrexate vs Placebo: Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Coronary Revascularization | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Major Adverse Cardiovascular Events | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With New Onset Type 2 Diabetes | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Hospitalization for Congestive Heart Failure | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With All-cause Mortality | Trial comparisons |
| Methotrexate vs Placebo: deaths from any cause | Trial comparisons |
| Methotrexate vs Placebo: Number of Subjects With Hospitalization for Unstable Angina That Led to Unplanned Coronary Revascularization | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT01594333
GET https://conductscience.org/api/trials/v1/NCT01594333/events?page=2