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.

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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