BCRC START UP Protocol Summaries

INDICATION

AGE CRITERIA

DESCRIPTION

Atrial fibrillation

65 yrs or older

A multicenter, international, randomized, placebo-controlled, double-blind, parallel-group, 2-arm, Phase 3 study to assess the efficacy and safety of asundexian (BAY 2433334) in participants aged 65 years and older with atrial fibrillation at risk for stroke who were deemed unsuitable to receive treatment with oral anticoagulants

BCRC Open Protocol Summary

INDICATION

AGE CRITERIA

DESCRIPTION

Heart failure

18+

Phase 3, Randomized, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the sGC Stimulator Vericiguat/MK-1242 in Adults With Stable Heart Failure With Reduced Ejection Fraction (VICTOR)

Coronary Artery Disease

18+

A phase 1c Multicenter, Randomized, Double-Blind, Placebo-Controlled study to assess the Safety, Pharmacokinetics, and Pharmacodynamics following 4 weeks of NLRP3 Inhibition with Selnoflast in participants with Coronary Artery Disease

Atrial fibrillation

18+ ≥ 75

A multicenter, international, randomized, active comparator-controlled, double-blind, double-dummy, parallel group, 2-arm Phase 3 study to compare the efficacy and safety of the oral FXIa inhibitor asundexian (BAY 2433334) with apixaban for the prevention of stroke or systemic embolism in male and female participants aged 18 years and older with atrial fibrillation at risk for stroke

Study of inclisiran to prevent cardiovascular events

≥ 40 but <80

A randomized, double-blind, placebo-controlled multicenter study to evaluate the effect of inclisiran on preventing major adverse cardiovascular events in high-risk primary prevention patients (VICTORION-1 PREVENT)

Hypertension

18+

A Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Multicenter Phase 2 to Evaluate The Efficacy And Safety of Lorundrostat In Subjects With Uncontrolled Hypertension on a Standardized Medication Regimen.

Atrial fibrillation

18+

A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Subjects with Atrial Fibrillation

Hypercholesterolemia Not Receiving Lipid-Lowering Therapy

≥ 18 to <75

A Double-blind, Randomized, Placebo-and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)