Statistical methods in cardiovascular trials
The methods these trials rely on most, based on the statistical analyses posted to ClinicalTrials.gov, with the tutorial that explains each one.
Kaplan-Meier estimation
Time-to-event endpoints
Hazard ratio
ANCOVA
Cox proportional-hazards model
Non-inferiority trial design
Multiple imputation / missing data
Odds ratio
All cardiovascular trials
90 results
- ACCELERATEComplete statistical analysis of ACCELERATE (NCT01687998), a randomized phase 3 study of evacetrapib versus placebo in high-risk vascular disease, including trial design, composite cardiovascular endpoints, Cox modeling, ANOVA, confidence intervals, p-values, and…
- AIM-HIGHIndependent statistical analysis of AIM-HIGH, the randomized phase 3 trial of extended-release niacin plus simvastatin versus placebo plus simvastatin for prevention of vascular events, including its time-to-event endpoints, Cox model, hazard ratios,…
- ALIASIndependent statistical analysis of ALIAS, a randomized phase 3 trial of albumin versus saline in acute ischemic stroke, including trial design, endpoints, logistic regression, risk ratios, nonparametric analysis, safety, and interpretation.
- AMBITIONIndependent statistical analysis of the AMBITION phase 3 trial of first-line ambrisentan and tadalafil combination therapy in pulmonary arterial hypertension, including time-to-event analysis, secondary endpoints, statistical methodology, safety, and interpretation.
- APPRAISE-2Independent statistical analysis of APPRAISE-2, the randomized phase 3 trial of apixaban versus placebo in acute coronary syndrome, including time-to-event endpoints, Cox models, hazard ratios, confidence intervals, p-values, and safety results.
- ARISTOTLEIndependent statistical analysis of ARISTOTLE (NCT00412984), including trial design, time-to-event endpoints, Cox proportional-hazards methodology, hazard ratios, confidence intervals, safety results, and statistical interpretation.
- ARTS-HFIndependent statistical analysis of the ARTS-HF phase 2 trial of finerenone in worsening chronic heart failure with left ventricular systolic dysfunction and selected diabetes or chronic kidney disease populations.
- ATLANTICIndependent statistical analysis of ATLANTIC (NCT01347580), a randomized phase 4 trial comparing pre-hospital versus in-hospital initiation of ticagrelor in STEMI patients planned for PCI.
- ATMOSPHEREIndependent statistical analysis of the ATMOSPHERE phase 3 trial of aliskiren and aliskiren/enalapril in chronic heart failure, including trial design, time-to-event endpoints, Cox modeling, non-inferiority, superiority, safety, and interpretation.
- AVERROESComplete statistical analysis of AVERROES, the randomized phase 3 study of apixaban versus acetylsalicylic acid in patients with atrial fibrillation, including trial design, time-to-event endpoints, hazard ratios, confidence intervals, safety, and statistical…
- BARI 2DIndependent statistical analysis of BARI 2D, a randomized phase 3 factorial trial comparing revascularization with medical therapy and insulin-sensitizing with insulin-providing glycemic strategies, including five-year all-cause mortality and death, myocardial infarction, or…
- BEAUTIFULIndependent statistical analysis of the phase 3 BEAUTIFUL trial of ivabradine versus placebo in patients with stable coronary artery disease and left ventricular systolic dysfunction, including its composite primary endpoint, time-to-event methods,…
- CARMELINAIndependent statistical analysis of CARMELINA (NCT01897532), a randomized phase 4 trial of linagliptin versus placebo in patients with type 2 diabetes mellitus, including time-to-event methodology, non-inferiority testing, cardiovascular and renal endpoints, safety,…
- CAROLINAIndependent statistical analysis of the CAROLINA phase 3 trial comparing linagliptin with glimepiride in patients with type 2 diabetes, including non-inferiority testing, cardiovascular outcomes, glycaemic control, ANCOVA, Cox regression, and logistic regression.
- CIRTComplete statistical analysis of CIRT (NCT01594333), a randomized phase 3 trial of methotrexate versus placebo in cardiovascular disease, including time-to-event endpoints, hazard ratios, confidence intervals, log-rank testing, stratification, multiplicity, safety, and statistical…
- CLEAR OutcomesIndependent statistical analysis of CLEAR Outcomes, the randomized phase 3 trial of bempedoic acid versus placebo in statin-intolerant participants with or at high risk for cardiovascular disease, including MACE, secondary time-to-event endpoints,…
- COAPTIndependent statistical analysis of the COAPT trial (NCT01626079), evaluating MitraClip in symptomatic heart failure with functional mitral regurgitation, including trial design, primary safety analysis, recurrent hospitalization, win ratio methodology, and statistical interpretation.
- COMPASSIndependent statistical analysis of the COMPASS phase 3 trial of rivaroxaban-based antithrombotic treatment in coronary or peripheral artery disease, including trial design, time-to-event endpoints, hazard ratios, safety outcomes, statistical methods, and interpretation.
- COMPASS-2Independent statistical analysis of COMPASS-2, evaluating bosentan added to sildenafil versus sildenafil monotherapy in pulmonary arterial hypertension, including time-to-event, functional, biomarker, quality-of-life, and safety results.
- COSSIndependent statistical analysis of the COSS phase 3 trial of extracranial-intracranial bypass surgery versus best medical therapy for symptomatic carotid occlusion, including its primary endpoint, secondary analyses, statistical methods, and interpretation.
- CREDENCEComplete statistical analysis of CREDENCE, the randomized phase 3 trial evaluating canagliflozin versus placebo for renal and cardiovascular outcomes in participants with type 2 diabetes and diabetic nephropathy.
- CRESTIndependent statistical analysis of CREST (NCT00004732), a randomized double-masked trial comparing carotid endarterectomy with carotid artery stenting for patients with carotid stenosis.
- CRYSTAL-AFIndependent statistical analysis of CRYSTAL-AF, evaluating continuous cardiac monitoring with an insertable cardiac monitor for atrial fibrillation detection after cryptogenic stroke or transient ischemic attack.
- DAPA-CKDIndependent statistical analysis of the randomized phase 3 DAPA-CKD trial evaluating dapagliflozin versus placebo for renal and cardiovascular outcomes in patients with chronic kidney disease.
- DAPA-HFIndependent statistical analysis of the DAPA-HF phase 3 trial evaluating dapagliflozin in patients with chronic heart failure with reduced ejection fraction, including trial design, endpoints, Cox models, win ratio, rate ratio, results,…
- DAPA-MIIndependent statistical analysis of the DAPA-MI phase 3 trial of dapagliflozin versus placebo after acute myocardial infarction, including its hierarchical primary composite endpoint, win-ratio methodology, trial design, interpretation, and safety.
- DELIVERIndependent statistical analysis of the DELIVER phase 3 trial of dapagliflozin in heart failure with preserved ejection fraction, including its dual primary time-to-event endpoints, Cox models, recurrent-event analysis, KCCQ analysis, safety, and…
- EINSTEIN-DVTIndependent statistical analysis of EINSTEIN-DVT, a randomized phase 3 trial of rivaroxaban versus enoxaparin followed by VKA in patients with venous thrombosis, including its non-inferiority analysis, Cox model, hazard ratio, confidence interval,…
- EINSTEIN-PEIndependent statistical analysis of EINSTEIN-PE, the randomized phase 3 trial of rivaroxaban versus enoxaparin followed by VKA in patients with acute symptomatic pulmonary embolism, including non-inferiority methodology, Cox analysis, hazard ratios, bleeding,…
- ELIXAIndependent statistical analysis of the ELIXA phase 3 trial of lixisenatide versus placebo in patients with acute coronary syndrome and type 2 diabetes, including its time-to-event endpoint, non-inferiority framework, hazard ratio, confidence…
- EMPA-REG OUTCOMEComplete statistical analysis of EMPA-REG OUTCOME, the randomized phase 3 trial of empagliflozin in patients with type 2 diabetes mellitus, including its time-to-event endpoints, Cox proportional-hazards analyses, non-inferiority framework, cardiovascular outcomes, microvascular…
- EMPEROR-PreservedA detailed statistical analysis of EMPEROR-Preserved, the randomized phase 3 trial of 10 mg empagliflozin versus placebo in patients with heart failure, including time-to-event outcomes, Cox models, recurrent-event analysis, MMRM, and interpretation.
- EMPEROR-ReducedIndependent statistical analysis of EMPEROR-Reduced, a randomized phase 3 trial of empagliflozin versus placebo in chronic heart failure with reduced ejection fraction. Includes the registered time-to-event endpoint, Cox and mixed-effects analyses, reported…
- EMPULSEIndependent statistical analysis of the EMPULSE phase 3 trial of empagliflozin in patients hospitalized for acute heart failure, including the primary win-ratio endpoint, secondary analyses, statistical methodology, safety, and interpretation.
- ENGAGE AF-TIMI 48Independent statistical analysis of ENGAGE AF-TIMI 48, evaluating edoxaban versus warfarin for stroke and systemic embolic events in patients with atrial fibrillation.
- ENVISAGE-TAVI AFComplete statistical analysis of ENVISAGE-TAVI AF, the randomized phase 3 trial comparing an edoxaban-based regimen with a vitamin K antagonist-based regimen in patients with atrial fibrillation after catheter-based heart valve replacement.
- EUROMAXComplete statistical analysis of the EUROMAX phase 3 trial of bivalirudin versus standard-of-care heparins with optional GPI in acute coronary syndrome, including trial design, the primary binary endpoint, risk ratio, confidence interval,…
- EXSCELA detailed independent statistical analysis of EXSCEL, the phase 3 trial of exenatide once weekly versus placebo in patients with type 2 diabetes mellitus, including its randomized design, time-to-event endpoints, Cox models,…
- FIGARO-DKDIndependent statistical analysis of FIGARO-DKD, a randomized phase 3 trial of finerenone versus placebo in subjects with type 2 diabetes mellitus and the clinical diagnosis of diabetic kidney disease.
- FINEARTS-HFIndependent statistical analysis of FINEARTS-HF, the randomized phase 3 trial evaluating finerenone versus placebo in participants with heart failure and left ventricular ejection fraction greater than or equal to 40%.
- FOURIERIndependent statistical analysis of the FOURIER phase 3 trial of evolocumab versus placebo in subjects with elevated cardiovascular risk and dyslipidemia, including time-to-event endpoints, hazard ratios, stratified log-rank testing, multiplicity, and interpretation.
- FREEDOMIndependent statistical analysis of the FREEDOM trial comparing coronary artery bypass grafting with percutaneous coronary intervention in individuals with diabetes and multivessel coronary artery disease, including time-to-event methods, reported results, safety, and…
- FREEDOM-CIndependent statistical analysis of FREEDOM-C, evaluating oral treprostinil versus placebo in pulmonary arterial hypertension, including trial design, 6MWD results, secondary endpoints, post-hoc analyses, statistical methodology, and interpretation.
- FREEDOM-C2Independent statistical analysis of the FREEDOM-C2 phase 3 trial of UT-15C SR versus placebo for pulmonary arterial hypertension, including the 6-minute walk distance endpoint, non-parametric ANCOVA, secondary analyses, safety, and statistical interpretation.
- FREEDOM-EVIndependent statistical analysis of FREEDOM-EV, a randomized phase 3 trial of treprostinil diolamine versus placebo in pulmonary arterial hypertension, covering clinical worsening, 6-minute walk distance, NT-proBNP, functional class, statistical methods, and safety.
- FREEDOM-MIndependent statistical analysis of FREEDOM-M, a randomized phase 3 trial of oral treprostinil versus placebo for pulmonary arterial hypertension, including 6-minute walk distance, statistical methodology, secondary analyses, safety, and interpretation.
- GALACTIC-HFIndependent statistical analysis of GALACTIC-HF, the randomized phase 3 trial of omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, including time-to-event methods, KCCQ analysis, confidence intervals, multiplicity, and safety.
- GALILEOComplete statistical analysis of the GALILEO phase 3 trial comparing a rivaroxaban-based antithrombotic strategy with an antiplatelet-based strategy after transcatheter aortic valve replacement, including endpoints, hazard ratios, confidence intervals, non-inferiority analysis, safety,…
- GEMINI-ACS-1Independent statistical analysis of GEMINI-ACS-1, a randomized phase 2 trial comparing rivaroxaban with acetylsalicylic acid in addition to P2Y12 inhibitor therapy in participants with acute coronary syndrome.
- Hokusai-VTEA complete statistical analysis of Hokusai-VTE, the randomized phase 3 trial comparing heparin/edoxaban with heparin/warfarin for symptomatic venous thromboembolism, including non-inferiority analysis, Cox modeling, bleeding outcomes, and statistical interpretation.