Current Trials

ORION 4 – examining the effects of inclisiran, a small interfering RNA (siRNA) that inhibits the synthesis of PCSK9, on cardiovascular outcomes among individuals with atherosclerotic cardiovascular disease.

VESALIUS-CV – assessing the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.

DAPA ACT HF – an investigator-initiated, randomized, double-blind, placebo-controlled trial in patients with heart failure who have been stabilized during hospitalization for acute heart failure, evaluating the effect of in-hospital initiation of dapagliflozin on the clinical outcome of cardiovascular death or worsening heart failure.

GOLDILOX is a Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Trial To Evaluate the Efficacy and Safety of MEDI6570 (a fully human monoclonal antibody against LOX-1) in Participants with a Prior Myocardial Infarction, Persistent Inflammation, and Elevated N-Terminal Prohormone Brain Natriuretic Peptide.

AZALEA – A phase 2b, multicenter, randomized, active-controlled study to evaluate the safety and tolerability of two blinded doses of the novel factor XI inhibitor abelacimab compared with open-label rivaroxaban in patients with atrial fibrillation.

COVID-PACT – a multicenter, randomized, open-label, 2 x 2 factorial design trial of full-dose anticoagulation vs. standard-dose prophylactic anticoagulation and antiplatelet therapy vs. no antiplatelet therapy on the risk of venous or arterial thrombotic events in ICU patients with COVID-19.

CORE – a phase 3 multicenter, randomized, double-blind, placebo-controlled trial of ~450 patients to evaluate the safety and efficacy of ISIS 678354, an antisense oligonucleotide inhibitor of apoC-III production, administered subcutaneously to patients with severe hypertriglyceridemia.

CORE2 CS6 – TIMI 72b is a phase 3 multicenter, randomized, double-blind, placebo-controlled trial in ~390 patients to evaluate the safety and efficacy of olezarsen, an antisense oligonucleotide inhibitor of apoC-III production, administered subcutaneously to patients with severe hypertriglyceridemia.

CS8 – TIMI 73a is a phase 3 multicenter, randomized, double-blind, placebo-controlled trial in ~152 patients to evaluate the safety and efficacy of olezarsen, an antisense oligonucleotide inhibitor of apoC-III production, administered subcutaneously to patients with either moderate hypertriglyceridemia and atherosclerotic cardiovascular disease (established or at increased risk for) or with severe hypertriglyceridemia.

ESSENCE CS9 – TIMI 73b is a phase 3 multicenter, randomized, double-blind, placebo-controlled trial in ~1320 patients to evaluate the safety and efficacy of olezarsen, an antisense oligonucleotide inhibitor of apoC-III production, administered subcutaneously to patients with either moderate hypertriglyceridemia and atherosclerotic cardiovascular disease (established or at increased risk for) or with severe hypertriglyceridemia.

GARDEN is a phase 2 trial testing the effect of ponsegromab, a novel monoclonal antibody directed against growth differentiation factor (GDF)-15, on health status and physical activity in patients with heart failure and elevated circulating GDF-15 concentrations.

OCEAN(a)-Outcomes (TIMI 75) will evaluate the efficacy and safety of lowering lipoprotein(a) through RNA interference with olpasiran in participants with atherosclerotic cardiovascular disease and elevated lipoprotein(a) concentrations.

LILAC – TIMI 76 is a randomized, double, blind placebo-controlled phase 3 trial investigating the efficacy and safety of the factor XI inhibitor abelacimab in~1,900 patients with AF deemed unsuitable for anticoagulation therapy.

For information about enrolling in a clinical trial, participating in a clinical trial, or starting a new clinical trial, contact Sue McHale / 617.278.0145.

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