Cardiovascular Clinical Trials

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.

All cardiovascular trials

90 results

• ISCHEMIA-CKDIndependent statistical analysis of ISCHEMIA-CKD, a randomized phase 4 trial comparing invasive and conservative strategies in patients with cardiovascular and kidney disease. Includes trial design, time-to-event endpoints, hazard-ratio interpretation, reported results, safety,…Phase 4Results postedn = 777NCT01985360
• LEADERComplete statistical analysis of the LEADER phase 3 trial of liraglutide versus placebo in type 2 diabetes, including trial design, cardiovascular time-to-event endpoints, Cox regression, non-inferiority and superiority testing, secondary outcomes, safety,…Phase 3Results postedn = 9,341NCT01179048
• NAVIGATE ESUSIndependent statistical analysis of NAVIGATE ESUS, a randomized phase 3 trial comparing rivaroxaban with aspirin in patients with recent embolic stroke of undetermined source, including time-to-event methods, primary and secondary results, safety,…Phase 3Results postedn = 7,213NCT02313909
• ODYSSEY OUTCOMESComplete statistical analysis of ODYSSEY OUTCOMES, the randomized phase 3 trial of alirocumab versus placebo after acute coronary syndrome, including time-to-event endpoints, hazard ratios, stratified log-rank testing, multiplicity, safety, and statistical interpretation.Phase 3Results postedn = 18,924NCT01663402
• ORIGINComplete statistical analysis of the ORIGIN phase 3 trial, including its factorial design, cardiovascular and diabetes endpoints, Cox and log-rank methods, odds ratios, confidence intervals, and statistical interpretation.Phase 3Results postedn = 12,537NCT00069784
• PARAGON-HFIndependent statistical analysis of PARAGON-HF, evaluating LCZ696 versus valsartan in heart failure with preserved ejection fraction, including primary and secondary endpoint analyses, statistical methods, interpretation, and limitations.Phase 3Results postedn = 4,822NCT01920711
• PATENT-1Independent statistical analysis of PATENT-1, a randomized phase 3 trial of oral riociguat in patients with pulmonary arterial hypertension, covering its 6-minute walking distance endpoint, ANCOVA, nonparametric and stratified analyses, secondary outcomes,…Phase 3Results postedn = 445NCT00810693
• PIONEER 6Independent statistical analysis of PIONEER 6, the randomized phase 3 trial of oral semaglutide versus placebo in subjects with type 2 diabetes, including its MACE endpoint, non-inferiority analysis, Cox model, hazard ratio,…Phase 3Results postedn = 3,183NCT02692716
• PIONEER AF-PCIComplete statistical analysis of PIONEER AF-PCI, the randomized phase 3 trial evaluating rivaroxaban-based strategies versus vitamin K antagonist therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention.Phase 3Results postedn = 2,124NCT01830543
• PIONEER-HFIndependent statistical analysis of PIONEER-HF, evaluating sacubitril/valsartan versus enalapril on NT-proBNP in patients stabilized after an acute heart failure episode. Includes trial design, ANCOVA methodology, reported primary and secondary results, safety, and…Phase 4Results postedn = 887NCT02554890
• POINTComplete statistical analysis of the POINT phase 3 trial of clopidogrel versus placebo in transient ischemic attack, including trial design, 90-day efficacy and hemorrhage endpoints, hazard ratios, confidence intervals, log-rank testing, and…Phase 3Results postedn = 4,881NCT00991029
• PRISMSIndependent statistical analysis of the PRISMS phase 3 trial of alteplase in participants with mild stroke, covering the Day 90 modified Rankin Scale endpoint, risk difference, odds ratios, safety outcomes, trial design,…Phase 3Results postedn = 313NCT02072226
• PRoFESSAn independent statistical analysis of PRoFESS (NCT00153062), including its randomized double-blind design, recurrent-stroke endpoints, Cox proportional-hazards analyses, non-inferiority framework, hazard ratios, confidence intervals, and secondary outcomes.Phase 4Results postedn = 20,332NCT00153062
• RE-COVER IIIndependent statistical analysis of RE-COVER II, a randomized phase 3 trial comparing dabigatran etexilate with warfarin for treatment of acute symptomatic venous thromboembolism, including non-inferiority and time-to-event analyses.Phase 3Results postedn = 2,589NCT00680186
• RE-LYComplete statistical analysis of the RE-LY phase 3 trial of dabigatran versus warfarin, including randomized trial design, time-to-event endpoints, Cox proportional-hazards analyses, non-inferiority and superiority comparisons, safety, and statistical interpretation.Phase 3Results postedn = 18,113NCT00262600
• RE-MODELComplete statistical analysis of the RE-MODEL phase 3 trial of dabigatran etexilate versus enoxaparin for prevention of thrombosis after knee surgery, including non-inferiority methodology, risk differences, confidence intervals, secondary endpoints, and safety.Phase 3Results postedn = 2,101NCT00168805
• RE-NOVATEIndependent statistical analysis of the RE-NOVATE phase 3 trial comparing dabigatran etexilate with enoxaparin for prevention of venous thromboembolism following total hip arthroplasty.Phase 3Results postedn = 2,055NCT00657150
• RE-SPECT ESUSIndependent statistical analysis of RE-SPECT ESUS, the randomized phase 3 trial of dabigatran etexilate versus aspirin for secondary stroke prevention after embolic stroke of undetermined source. Includes trial design, time-to-event endpoints, Cox…Phase 3Results postedn = 5,390NCT02239120
• RED-HFIndependent statistical analysis of the RED-HF phase 3 trial of darbepoetin alfa in heart failure, including trial design, time-to-event endpoints, hazard ratios, KCCQ analyses, safety, methodology, and statistical interpretation.Phase 3Results postedn = 2,278NCT00358215
• REDUCE-ITComplete statistical analysis of REDUCE-IT (NCT01492361), a randomized phase 3 trial of AMR101 versus placebo in high-risk patients with cardiovascular disease and hypertriglyceridemia on statin therapy.Phase 3Results postedn = 8,179NCT01492361
• REVEALIndependent statistical analysis of the phase 3 REVEAL trial of anacetrapib versus placebo in atherosclerotic cardiovascular disease, including trial design, time-to-event endpoints, log-rank analysis, rate ratios, confidence intervals, safety, and statistical interpretation.Phase 3Results postedn = 30,449NCT01252953
• REWINDComplete statistical analysis of the REWIND phase 3 trial of dulaglutide versus placebo in type 2 diabetes and cardiovascular disease, including its randomized design, time-to-event endpoints, Cox proportional-hazards analysis, cardiovascular outcomes, and…Phase 3Results postedn = 9,901NCT01394952
• ROCKET AFIndependent statistical analysis of ROCKET AF, the randomized phase 3 trial of rivaroxaban versus warfarin for prevention of stroke and non-CNS systemic embolism in patients with non-valvular atrial fibrillation.Phase 3Results postedn = 14,269NCT00403767
• SCOREDIndependent statistical analysis of SCORED (NCT03315143), a randomized phase 3 trial of sotagliflozin versus placebo in participants with type 2 diabetes and moderate renal impairment at cardiovascular risk. Includes the primary cardiovascular…Phase 3Results postedn = 10,584NCT03315143
• SELECTAn independent statistical analysis of the SELECT phase 3 trial of semaglutide versus placebo in patients with overweight or obesity, including trial design, the primary time-to-event endpoint, Cox proportional-hazards analysis, and interpretation.Phase 3Results postedn = 17,604NCT03574597
• SHIFTComplete statistical analysis of SHIFT, a randomized phase 3 trial evaluating ivabradine versus placebo in patients with chronic heart failure, including Cox proportional-hazards methods, hazard ratios, confidence intervals, p-values, safety, and statistical…Phase 3Results postedn = 6,505NCT02441218
• SIGNIFYIndependent statistical analysis of SIGNIFY (NCT02446990), a randomized phase 3 trial of ivabradine versus placebo in patients with stable coronary artery disease without clinical heart failure, including Cox proportional-hazards analyses and interpretation…Phase 3Results postedn = 19,102NCT02446990
• SOCRATESIndependent statistical analysis of the SOCRATES phase 3 trial of ticagrelor versus acetylsalicylic acid after acute ischaemic stroke or transient ischaemic attack, including endpoint definitions, Cox and logistic regression methods, efficacy results,…Phase 3Results postedn = 13,307NCT01994720
• SOLOIST-WHFIndependent statistical analysis of SOLOIST-WHF (NCT03521934), evaluating sotagliflozin versus placebo in participants with type 2 diabetes and worsening heart failure. Includes trial design, registered endpoints, Cox, ANCOVA and MMRM methodology, reported results,…Phase 3Results postedn = 1,222NCT03521934
• STELLARIndependent statistical analysis of the phase 3 STELLAR trial of sotatercept plus background PAH therapy versus placebo plus background PAH therapy in pulmonary arterial hypertension, including trial design, endpoints, nonparametric analyses, hazard…Phase 3Results postedn = 324NCT04576988
• STRENGTHComplete statistical analysis of the STRENGTH phase 3 trial of Epanova versus corn oil control in high cardiovascular risk patients with hypertriglyceridemia, including trial design, MACE, Cox proportional-hazards analysis, secondary endpoints, safety,…Phase 3Results postedn = 13,078NCT02104817
• STROKE-AFIndependent statistical analysis of STROKE-AF (NCT02700945), a randomized trial evaluating atrial fibrillation detection through 12 months with Reveal LINQ insertable cardiac monitoring after recent ischemic stroke of presumed known origin.Phase NAResults postedn = 496NCT02700945
• TECOSComplete statistical analysis of TECOS, the randomized phase 3 study of sitagliptin versus placebo in type 2 diabetes mellitus, including non-inferiority analysis of MACE plus, Cox proportional-hazards methodology, secondary endpoints, safety, and…Phase 3Results postedn = 14,671NCT00790205
• THALESComplete statistical analysis of the phase 3 THALES trial of ticagrelor versus placebo in acute ischaemic stroke and transient ischaemic attack, including trial design, endpoints, Cox and logistic regression methods, efficacy results,…Phase 3Results postedn = 11,016NCT03354429
• THEMISIndependent statistical analysis of THEMIS, a randomized phase 3 trial of ticagrelor 60 mg versus placebo in patients with type 2 diabetes mellitus, including time-to-event methods, hazard ratios, confidence intervals, safety analyses,…Phase 3Results postedn = 19,271NCT01991795
• TRA 2P-TIMI 50Independent statistical analysis of TRA 2P-TIMI 50 (NCT00526474), including randomized trial design, time-to-event endpoints, Cox proportional-hazards methods, efficacy results, bleeding outcomes, post-hoc analyses, and statistical interpretation.Phase 3Results postedn = 26,449NCT00526474
• TRANSITIONIndependent statistical analysis of the TRANSITION phase 4 trial comparing pre- and post-discharge initiation of LCZ696 in patients with heart failure with reduced ejection fraction after an acute decompensation event.Phase 4Results postedn = 1,002NCT02661217
• VESALIUS-CVComplete statistical analysis of VESALIUS-CV, evaluating evolocumab versus placebo in patients at high cardiovascular risk without prior myocardial infarction or stroke. Includes trial design, time-to-event endpoints, hazard ratios, confidence intervals, statistical methodology,…Phase 3Results postedn = 12,301NCT03872401
• VICTORIAIndependent statistical analysis of the VICTORIA phase 3 trial of vericiguat versus placebo in participants with heart failure with reduced ejection fraction, including trial design, time-to-event endpoints, hazard ratios, confidence intervals, safety,…Phase 3Results postedn = 5,050NCT02861534
• VOYAGER PADA detailed independent statistical analysis of VOYAGER PAD, the randomized phase 3 trial of rivaroxaban plus aspirin versus placebo plus aspirin in symptomatic peripheral artery disease undergoing lower-extremity peripheral revascularization.Phase 3Results postedn = 6,564NCT02504216

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