Clinical Research Trials

ZEUS – Inflammation/CVD/CKD

This study is conducted to see if Ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. NCT05021835

REDEFINE – CVD/Obesity

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease. Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body. Which treatment participants will get will be decided by chance. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years. NCT05669755

AGENT IDE

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter. NCT04647253

WARRIOR

The Ischemia-IMT (Ischemia-Intensive Medical Treatment Reduces Events in Women with Non-Obstructive CAD), subtitle: Women's Ischemia Trial to Reduce Events in Non-Obstructive CAD (WARRIOR) trial is a multicenter, prospective, randomized, blinded outcome evaluation (PROBE design) evaluating intensive statin/ACE-I (or ARB)/aspirin treatment (IMT) vs. usual care (UC) in 4,422 symptomatic women patients with symptoms and/or signs of ischemia but no obstructive CAD. NCT03417388

HERMES – Heart Failure

This study will be done to see if Ziltivekimab can be used to treat people living with heart failure and inflammation. Participants will either get Ziltivekimab or placebo. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have to use a study app on their phone to record and share information about all their injections of study medicine and to fill in questionnaires. NCT05636176

SUMMIT – Heart Failure / Obesity

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity. NCT04847557

OCEAN(a) – Lp(a)

The primary objective of this study is to compare the effect of treatment with Olpasiran, to placebo, on the risk for coronary heart disease death (CHD death), myocardial infarction, or urgent coronary revascularization in participants with atherosclerotic cardiovascular disease (ASCVD) and elevated Lipoprotein(a). NCT05581303

PLAQUE – LDL (Inclisiran)

CKJX839D12303 is a research study to determine if the study treatment, called inclisiran, in comparison to placebo taken in addition to statin medication can effectively reduce the total amount of plaque formed in the heart's vessels as measured by coronary computed tomography angiography (CCTA) from baseline to month 24. This study is being conducted in eligible participants with a diagnosis of non-obstructive coronary artery disease (NOCAD), where the coronary arteries are blocked less than 50%, and with no previous cardiovascular events. NCT0536046

PREVENT – LDL (Inclisiran)

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD). NCT05030428

INCEPTION – LDL (Inclisiran)

The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug. NCT04873934

EVOLE MI – Repatha

The primary objective of this study is to evaluate the effectiveness of early treatment with Evolocumab plus routine lipid management vs routine lipid management alone when administered in the acute setting to reduce myocardial infarction, ischemic stroke, arterial revascularization, and all-cause death in subjects hospitalized for an acute myocardial infarction (non-ST-segment elevation myocardial infarction [NSTEMI] and ST-segment elevation myocardial infarction [STEMI]).

AT-02 in Healthy Volunteers and Subjects with Systemic Amyloidosis (AT02-001)

This is a multicenter, international, three-part, Phase 1 study designed to evaluate the safety, tolerability, and PK of rising single doses of AT-02 in healthy volunteers and in subjects with systemic amyloidosis and to assess the safety, tolerability, and PK of multiple doses of AT-02 in subjects with systemic amyloidosis.

Amyloid AT–02 OLE

This is a Phase 2 open-label extension study to evaluate the long-term safety, tolerability, and clinical activity of AT-02.

AT-02 is an investigational medicinal product being developed to treat systemic amyloidosis.

COMPLETE TAVR

Patients undergoing transcatheter aortic valve replacement (TAVR) often have concomitant coronary artery disease (CAD) which may adversely affect prognosis. There is uncertainty about the benefits and the optimal timing of revascularization for such patients. There is currently clinical equipoise regarding the management of concomitant CAD in patients undergoing TAVR. Some centers perform routine revascularization with percutaneous coronary intervention (PCI) (either before or after TAVR), while others follow an alternative strategy of medical management. NCT04634240

LEAAPS

This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke. NCT05478304

PFO PAS

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting. NCT03309332

Elucidate FFRCT

The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR).

Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have previously undergone CCTA and invasively assessed FFR.

CONFIRM2

The CONFIRM study was developed to examine the prognostic value of cardiac computed tomographic angiography (CCTA) findings for prediction of future adverse cardiac events related to coronary artery disease (CAD) in a large, international patient population. The purpose of this multicenter registry is to correlate coronary and non-coronary cardiac findings by CCTA with demographic and clinical data for refinement of risk stratification of individuals with suspected or known CAD.