Trial · NCT02586155

Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD

NCT02586155, Phase 3, Completed, Resverlogix Corp; results first posted 2021-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD. Trials, record NCT02586155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02586155

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD
NCT number: NCT02586155
Status: Completed
Phases: Phase 3
Enrollment: 2,425 participants, actual
Lead sponsor: Resverlogix Corp
Conditions: Diabetes Mellitus, Type 2, Coronary Artery Disease
Interventions: Apabetalone, Placebo, Atorvastatin, Rosuvastatin
First posted: 2015-10-26
Last updated: 2021-08-20
Results first posted: 2021-08-20

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	120 weeks	Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
Secondary	Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	120 weeks	First occurrence of MACE broadly defined as a single composite endpoint of Cardiovascular Death (CVD) (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI), Stroke, or Hospitalization for CVD events (including unstable angina and evidence of new or presumed new progressive obstructive coronary disease or emergency revascularization procedures at any time and urgent revascularization procedures ≥30 days after the index event as defined by Hicks et al., 2014) . If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
Secondary	Incidence of Hospitalization for Congestive Heart Failure (CHF)	120 weeks
Secondary	Incidence of All-cause Mortality	120 weeks
Secondary	Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks
Secondary	Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks
Secondary	Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks
Secondary	Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks
Secondary	Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks
Secondary	Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups	120 weeks

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	120 weeks		events	NUMBER
SECONDARY	Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	120 weeks		events	NUMBER
SECONDARY	Incidence of Hospitalization for Congestive Heart Failure (CHF)	120 weeks		events	NUMBER
SECONDARY	Incidence of All-cause Mortality	120 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Apolipoprotein A1 (ApoA-I) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks	A select subset of subjects were analyzed for ApoA-I, Subject data is missing across time points.	mg/dL	MEDIAN
SECONDARY	Change in Apolipoprotein B (apoB) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks	A select subset of subjects were analyzed for ApoB, Subject data is missing across time points.	mg/dL	MEDIAN
SECONDARY	Change in LDL-C Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks	All subjects were analyzed and contributed LDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.~Subject data is missing across time points.	mmol/L	MEDIAN
SECONDARY	Change in HDL-C Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks	All subjects were analyzed and contributed HDL-C data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.~Subject data is missing across time points.	mmol/L	MEDIAN
SECONDARY	Change in Triglyceride (TG) Concentration From Baseline Over Time Within and Between Treatment Groups	120 weeks	All subjects were analyzed and contributed TG data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms.~Subject data is missing across time points.	mmol/L	MEDIAN
SECONDARY	Change in Hemoglobin (Hb) A1c From Baseline Over Time Within and Between Treatment Groups	120 weeks	All subjects were analyzed and contributed HbA1c data for the 'High-Intensity Statin Therapy + RVX000222' and the 'High-Intensity statin therapy + Placebo' arms Subject data is missing across time points	% of hemoglobin	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group192

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+RVX000222	CV Death	34	events
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+Placebo	CV Death	42	events
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+RVX000222	Non-fatal MI	76	events
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+Placebo	Non-fatal MI	92	events
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+RVX000222	Stroke	15	events
Incidence of First Occurrence of Adjudication-confirmed Narrowly Defined MACE	High-Intensity Statin Therapy+Placebo	Stroke	15	events
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	High-Intensity Statin Therapy+RVX000222	CV Death	33	events
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	High-Intensity Statin Therapy+Placebo	CV Death	42	events
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	High-Intensity Statin Therapy+RVX000222	Non-fatal MI	74	events
Incidence of First Occurrence of Adjudication-confirmed Broadly Defined MACE	High-Intensity Statin Therapy+Placebo	Non-fatal MI	91	events

1 to 10 of 192Source ClinicalTrials.gov

See all 192 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	High-Intensity Statin Therapy+RVX000222	1,215
Overall Study	STARTED	High-Intensity Statin Therapy+Placebo	1,210
Overall Study	Final Number Randomized	High-Intensity Statin Therapy+RVX000222	1,212
Overall Study	Final Number Randomized	High-Intensity Statin Therapy+Placebo	1,206
Overall Study	COMPLETED	High-Intensity Statin Therapy+RVX000222	1,088
Overall Study	COMPLETED	High-Intensity Statin Therapy+Placebo	1,083
Overall Study	NOT COMPLETED	High-Intensity Statin Therapy+RVX000222	127
Overall Study	NOT COMPLETED	High-Intensity Statin Therapy+Placebo	127

Source ClinicalTrials.gov

Adverse events778

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
other	Nasopharyngitis	Infections and infestations	High-Intensity Statin Therapy+RVX000222	46	1,212
other	Nasopharyngitis	Infections and infestations	High-Intensity Statin Therapy+Placebo	56	1,207
other	Urinary tract infection	Infections and infestations	High-Intensity Statin Therapy+RVX000222	58	1,212
other	Urinary tract infection	Infections and infestations	High-Intensity Statin Therapy+Placebo	40	1,207
other	Influenza	Infections and infestations	High-Intensity Statin Therapy+RVX000222	43	1,212
other	Influenza	Infections and infestations	High-Intensity Statin Therapy+Placebo	47	1,207
other	Bronchitis	Infections and infestations	High-Intensity Statin Therapy+RVX000222	25	1,212
other	Bronchitis	Infections and infestations	High-Intensity Statin Therapy+Placebo	32	1,207
other	Pneumonia	Infections and infestations	High-Intensity Statin Therapy+RVX000222	27	1,212
other	Pneumonia	Infections and infestations	High-Intensity Statin Therapy+Placebo	26	1,207

1 to 10 of 778Source ClinicalTrials.gov

See all 778 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	High-Intensity Statin Therapy+RVX000222	61	1,212
Total, all-cause mortality	High-Intensity Statin Therapy+Placebo	72	1,207
Total, other adverse events	High-Intensity Statin Therapy+RVX000222	830	1,212
Total, other adverse events	High-Intensity Statin Therapy+Placebo	820	1,207
Total, serious adverse events	High-Intensity Statin Therapy+RVX000222	354	1,212
Total, serious adverse events	High-Intensity Statin Therapy+Placebo	339	1,207

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30476723	DERIVED	PubMed
31520897	DERIVED	PubMed
31725015	DERIVED	PubMed
32219359	RESULT	PubMed
34158057	DERIVED	PubMed

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 comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
High-Intensity Statin Therapy+RVX000222 vs High-Intensity Statin Therapy+Placebo: Incidence of All-cause Mortality	Trial comparisons
High-Intensity Statin Therapy+RVX000222 vs High-Intensity Statin Therapy+Placebo: deaths from any cause	Trial comparisons
High-Intensity Statin Therapy+RVX000222 vs High-Intensity Statin Therapy+Placebo: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02586155

GET https://conductscience.org/api/trials/v1/NCT02586155/results?page=2

API reference For AI assistants