Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Conditions

Cardiovascular Disease, Diabetes Mellitus, Type 2

Keywords

Cardiovascular disease, Diabetes Mellitus, Dulaglutide

Brief summary

The purpose of this trial is to assess whether dulaglutide can reduce major cardiovascular events and other serious outcomes in persons with type 2 diabetes, when added to their anti-hyperglycemic regimen.

Toliver J, Wang J, Bhavsar J, Sullivan SD.

2026-01-21

10.1080/13696998.2026.2615606

Gender differences in cardiovascular risk, treatment, and outcomes: a post hoc analysis from the REWIND trial.

Ferrannini G, Maldonado JM, Raha S, Rao-Melacini P, Khatun R, Atisso C, Shurzinske L, Gerstein HC, Rydén L, Bethel MA.

2023-12-018 citations

10.1080/14017431.2023.2166101

A novel kidney disease index reflecting both the albumin-to-creatinine ratio and estimated glomerular filtration rate, predicted cardiovascular and kidney outcomes in type 2 diabetes

Hertzel C. Gerstein, Chinthanie Ramasundarahettige, Alvero Avezum, Jan Basile, Ignacio Conget et al. (20 authors)

Cardiovascular Diabetology2022-08-2214 citations

10.1186/s12933-022-01594-6

731-P: Metabolite Biomarkers and Cardiovascular Events in REWIND: A Post Hoc Analysis

VALENTINA PIRRO, Guillaume Paré, SHUN FU LEE, HELEN M. COLHOUN, YANZHU LIN et al. (10 authors)

Diabetes2022-05-31

10.2337/db22-731-p

Glucagon-like Peptide-1 Receptor Analogues for the Treatment of Obesity.

Williams DM, Staff M, Bain SC, Min T.

2022-03-185 citations

10.17925/ee.2022.18.1.43

Exploring potential mediators of the cardiovascular benefit of dulaglutide in type 2 diabetes patients in REWIND.

Konig M, Riddle MC, Colhoun HM, Branch KR, Atisso CM, Lakshmanan MC, Mody R, Raha S, Gerstein HC.

2021-09-2543 citations

10.1186/s12933-021-01386-4

Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial.

Bajaj HS, Gerstein HC, Rao-Melacini P, Basile J, Colhoun H, Conget I, Cushman WC, Dagenais GR, Franek E, Hanefeld M, Keltai M, Lakshmanan M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Probstfield J, Raubenheimer P, Ryden L, Shaw JE, Sheu WH, Xavier D.

2021-06-1831 citations

10.1016/s2213-8587(21)00115-7

Generalizability of the Results of Cardiovascular Outcome Trials of Glucagon-Like Peptide 1 Receptor Agonists in Chinese Patients with Type 2 Diabetes Mellitus.

Cai X, Ji L.

2021-05-285 citations

10.1007/s13300-021-01079-x

Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis.

Dagenais GR, Rydén L, Leiter LA, Lakshmanan M, Dyal L, Probstfield JL, Atisso CM, Shaw JE, Conget I, Cushman WC, Lopez-Jaramillo P, Lanas F, Munoz EGC, Pirags V, Pogosova N, Basile J, Sheu WHH, Temelkova-Kurktschiev T, Raubenheimer PJ, Keltai M, Hall S, Pais P, Colhoun HM, Riddle MC, Gerstein HC.

2020-11-2525 citations

10.1186/s12933-020-01179-1

Abstract 15586: Burden of Cardiovascular or Fatal Outcomes in People With Type 2 Diabetes and Cardiovascular Risk Factors Treated With Dulaglutide a Post Hoc Analysis From the Rewind Trial

Gilles R. Dagenais, Mark Lakshmanan, Leanne Dyal, Charles Atisso, Helen M. Colhoun et al. (7 authors)

Circulation2020-11-171 citations

10.1161/circ.142.suppl_3.15586

Effect of dulaglutide on cognitive impairment in type 2 diabetes: an exploratory analysis of the REWIND trial.

Cukierman-Yaffe T, Gerstein HC, Colhoun HM, Diaz R, García-Pérez LE, Lakshmanan M, Bethel A, Xavier D, Probstfield J, Riddle MC, Rydén L, Atisso CM, Hall S, Rao-Melacini P, Basile J, Cushman WC, Franek E, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T.

2020-07-01213 citations

10.1016/s1474-4422(20)30173-3

The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.

Gerstein HC, Hart R, Colhoun HM, Diaz R, Lakshmanan M, Botros FT, Probstfield J, Riddle MC, Rydén L, Atisso CM, Dyal L, Hall S, Avezum A, Basile J, Conget I, Cushman WC, Hancu N, Hanefeld M, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Muñoz EGC, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T.

2020-01-0786 citations

10.1016/s2213-8587(19)30423-1

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T, REWIND Investigators.

2019-06-091,912 citations

10.1016/s0140-6736(19)31149-3

Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.

Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Botros FT, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T, REWIND Investigators.

2019-06-09410 citations

10.1016/s0140-6736(19)31150-x

Implications of cardiovascular outcome trials with injectable antidiabetic agents

Richard E. Pratley

Journal of Diabetes2018-07-044 citations

10.1111/1753-0407.12792

Interventions

DRUGDulaglutide

Administered subcutaneously

DRUGPlacebo

Administered subcutaneously

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Type 2 diabetes with Hemoglobin A1c equal to or less than 9.5% (equal to or less than 81 mmol/mol) * Anti-hyperglycemic drug naive or treated with up to 2 oral hyperglycemic drugs with or without a glucagon-like peptide-1analog or basal insulin, or basal insulin alone * On stable antihyperglycemic regimen for at least 3 months * Age equal to or greater than 50 years with established clinical vascular disease, or age equal to or greater than 55 years and subclinical vascular disease or age equal to or greater than 60 years and at least 2 or more cardiovascular risk factors

Exclusion criteria

* Uncontrolled diabetes requiring immediate therapy * History of severe hypoglycemia in past year * Acute coronary or cerebrovascular event within past 2 months * Planned or anticipated revascularization procedure * History of pancreatitis, hepatic insufficiency , chronic renal failure or of C-cell thyroid disorder * Pregnancy or planned pregnancy during the trial period * Completed or withdrawn from any study investigating dulaglutide

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

Secondary

Measure	Time frame	Description
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)	The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.
Number of Participants Who Experienced an Event for Time to All-cause Mortality	From randomization to study completion (Median Follow-Up of 5.4 Years)	The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)	The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.
Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)	The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.
Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina	From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)	Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Countries

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Germany, Hungary, Latvia, Lithuania, Mexico, New Zealand, Poland, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States

Participant flow

Pre-assignment details

Participants were randomized to either placebo or Dulaglutide. Completers included participants for whom vital status was ascertained during the study close-out period and endpoint completers.

Participants by arm

Arm	Count
Placebo Placebo was administered once weekly, subcutaneously	4,952
Dulaglutide 1.5 mg Dulaglutide was administered once weekly, subcutaneously	4,949
Total	9,901

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	5
Overall Study	Physician Decision	2	0
Overall Study	Sponsor Decision	5	7
Overall Study	Withdrawal by Subject	10	5

Baseline characteristics

Characteristic	Dulaglutide	Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	2619 Participants	2637 Participants	5256 Participants
Age, Categorical Between 18 and 65 years	2330 Participants	2315 Participants	4645 Participants
Age, Continuous	66.2 years STANDARD_DEVIATION 6.5	66.2 years STANDARD_DEVIATION 6.5	66.2 years STANDARD_DEVIATION 6.5
Ethnicity (NIH/OMB) Hispanic or Latino	60 Participants	64 Participants	124 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	400 Participants	402 Participants	802 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4489 Participants	4486 Participants	8975 Participants
Race (NIH/OMB) American Indian or Alaska Native	549 Participants	543 Participants	1092 Participants
Race (NIH/OMB) Asian	216 Participants	218 Participants	434 Participants
Race (NIH/OMB) Black or African American	331 Participants	346 Participants	677 Participants
Race (NIH/OMB) More than one race	87 Participants	79 Participants	166 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	12 Participants	22 Participants	34 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	3754 Participants	3744 Participants	7498 Participants
Region of Enrollment Argentina	697 Participants	698 Participants	1395 Participants
Region of Enrollment Australia	44 Participants	44 Participants	88 Participants
Region of Enrollment Brazil	138 Participants	137 Participants	275 Participants
Region of Enrollment Bulgaria	51 Participants	50 Participants	101 Participants
Region of Enrollment Canada	564 Participants	564 Participants	1128 Participants
Region of Enrollment Chile	64 Participants	64 Participants	128 Participants
Region of Enrollment Colombia	393 Participants	392 Participants	785 Participants
Region of Enrollment Czechia	106 Participants	107 Participants	213 Participants
Region of Enrollment Germany	293 Participants	292 Participants	585 Participants
Region of Enrollment Hungary	110 Participants	113 Participants	223 Participants
Region of Enrollment Latvia	39 Participants	39 Participants	78 Participants
Region of Enrollment Lithuania	53 Participants	52 Participants	105 Participants
Region of Enrollment Mexico	219 Participants	219 Participants	438 Participants
Region of Enrollment New Zealand	115 Participants	119 Participants	234 Participants
Region of Enrollment Poland	303 Participants	305 Participants	608 Participants
Region of Enrollment Romania	541 Participants	544 Participants	1085 Participants
Region of Enrollment Russia	51 Participants	50 Participants	101 Participants
Region of Enrollment South Africa	372 Participants	369 Participants	741 Participants
Region of Enrollment South Korea	60 Participants	62 Participants	122 Participants
Region of Enrollment Spain	65 Participants	62 Participants	127 Participants
Region of Enrollment Sweden	119 Participants	117 Participants	236 Participants
Region of Enrollment Taiwan	13 Participants	13 Participants	26 Participants
Region of Enrollment United Kingdom	71 Participants	65 Participants	136 Participants
Region of Enrollment United States	468 Participants	475 Participants	943 Participants
Sex: Female, Male Female	2306 Participants	2283 Participants	4589 Participants
Sex: Female, Male Male	2643 Participants	2669 Participants	5312 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	592 / 4,949	536 / 4,943
other Total, other adverse events	3,363 / 4,949	3,574 / 4,943
serious Total, serious adverse events	2,044 / 4,949	1,991 / 4,943

Outcome results

Primary

Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite endpoint) was evaluated using time-to-event analysis. The primary analysis model was a Cox proportional hazards regression model for the time to the first occurrence of a primary endpoint event, with treatment as a fixed effect using the intent-to-treat population. The number of participants who experienced a primary cardiovascular (CV) endpoint event is presented.

Time frame: From randomization to first occurrence or death from any cause or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	663 Participants
Dulaglutide	Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)	594 Participants

Comparison: Primary CV endpointp-value: 0.02695.33% CI: [0.79, 0.99]Regression, Cox

Secondary

Number of Participants Who Experienced an Event for Time to All-cause Mortality

The time to all-cause mortality was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Time frame: From randomization to study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced an Event for Time to All-cause Mortality	592 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to All-cause Mortality	536 Participants

Comparison: Time to all cause mortalityp-value: 0.06795% CI: [0.8, 1.01]Regression, Cox

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually

The time from randomization to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (individually) was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. Death from CV causes is defined as a death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, or death due to other CV causes. The number of participants who experienced an event is presented.

Time frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Death from CV causes	346 Participants
Placebo	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Nonfatal MI	212 Participants
Placebo	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Nonfatal stroke	175 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Death from CV causes	317 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Nonfatal MI	205 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually	Nonfatal stroke	135 Participants

Comparison: Death from CV causesp-value: 0.21195% CI: [0.78, 1.06]Regression, Cox

Comparison: Nonfatal MIp-value: 0.65295% CI: [0.79, 1.16]Regression, Cox

Comparison: Nonfatal strokep-value: 0.01795% CI: [0.61, 0.95]Regression, Cox

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina

Time to first occurrence after randomization of first hospitalization for unstable angina was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Time frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina	77 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina	88 Participants

Comparison: Hospitalization for unstable anginap-value: 0.41395% CI: [0.84, 1.54]Regression, Cox

Secondary

Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit

The time to first occurrence after randomization of heart failure requiring hospitalization or an urgent heart failure clinic visit was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The number of participants who experienced an event is presented.

Time frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	226 Participants
Dulaglutide	Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit	213 Participants

Comparison: Heart failure requiring hospitalization or an urgent heart failure clinic visitp-value: 0.45695% CI: [0.77, 1.12]Regression, Cox

Secondary

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint

The time from randomization to first occurrence of the composite microvascular endpoint was evaluated using time-to-event analysis via the Cox proportional hazards regression model where response equals treatment. The composite microvascular endpoint is defined as diabetic retinopathy requiring laser therapy, vitrectomy, or anti-vascular endothelial growth factor therapy (VEGF), clinical proteinuria, a greater than equal ≥ 30% decline in estimated glomerular filtration rate, or need for chronic renal replacement therapy. The number of participants who experienced the composite microvascular endpoint event is presented.

Time frame: From randomization to first occurrence or study completion (Median Follow-Up of 5.4 Years)

Population: All randomized participants.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint	1241 Participants
Dulaglutide	Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint	1099 Participants

Comparison: microvascular endpointp-value: <0.00195% CI: [0.79, 0.93]Regression, Cox

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Number of Participants Who Experienced an Event For Time, From Randomization to First Occurrence of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke (a Composite Cardiovascular Outcome)

Number of Participants Who Experienced an Event for Time to All-cause Mortality

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke, Individually

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of First Hospitalization for Unstable Angina

Number of Participants Who Experienced An Event for Time to First Occurrence After Randomization of Heart Failure Requiring Hospitalization or an Urgent Heart Failure Clinic Visit

Number of Participants Who Experienced an Event for Time to First Occurrence After Randomization of the Composite Microvascular Endpoint