Clinical Trials at Saint Michael’s Medical Center

Advancing Medical Science, Improving Patient Care

At Saint Michael’s Medical Center, we are committed to providing our patients with access to the most advanced therapies and treatment options available. Our robust clinical trials program plays a crucial role in this mission, offering cutting-edge research opportunities that may shape the future of healthcare.

For more information, please call (973) 877-2663.

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What Are Clinical Trials?

Clinical trials are carefully designed research studies that evaluate new medical approaches, including:

Medications
Devices
Treatment strategies
Prevention methods

These trials help determine the safety and effectiveness of new interventions, potentially leading to breakthrough treatments for various conditions.

Why Participate in a Clinical Trial?

Participating in a clinical trial offers several benefits:

Access to novel treatments not yet widely available
Contribute to the advancement of medical knowledge
Receive expert medical care and close monitoring
Play an active role in your own healthcare
Help future patients by contributing to medical research

A doctor or scientist in laboratory holding a syringe

Our Current Clinical Trials

Saint Michael’s Medical Center is proud to offer a diverse range of clinical trials across multiple medical specialties. Some of our current studies include:

Cardiology Trials (Dr. Abbas Shehadeh)

Phase III trial evaluating dapagliflozin for heart failure with reduced ejection fraction
Study on olpasiran for atherosclerotic cardiovascular disease with elevated Lipoprotein(a)
Research on ziltivekimab for heart failure with mildly reduced or preserved ejection fraction
Trial of flecainide acetate inhalation solution for atrial fibrillation

Current Cardiology Clinical Trails (0826/24)
PI- Abbas Shehadeh
Phase III

D1690C00078

A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients with Heart Failure with Reduced Ejection Fraction Who Have Been Stabilized During Hospitalization for Acute Heart Failure.

20180244

A Double-blind, Randomized, Placebo-controlled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)

HERMES

Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation

ID-076A301

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm (RESTORE-1)

HIV/AIDS and Infectious Disease Trials (Dr. Jihad Slim)

Multiple phase II and III trials evaluating new antiretroviral therapies and treatment strategies
Studies on long-acting HIV medications and novel drug combinations
Observational study on multidrug-resistant HIV patient outcomes

Current Clinical Trails (08/12/24)
Phase I

GS-US-425-6143

A Phase 1b Randomized, Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GS-8588 in People With HIV-1 Who are Virologically Suppressed on Antiretroviral Therapy (.

Phase II

GSK209639

A study to investigate the virologic efficacy and safety of VH3810109 + Cabotegravir compared to SOC in male and female adults with HIV infection EMBRACE: Efficacy of Monoclonal anti-Body Regimen VH3810109 And CabotEgravir

M19-965

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption.

GS-US-695-6509

An Operationally Seamless Phase 2/3, Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Oral Weekly Regimen of GS-1720 in Combination With GS-4182 Versus Biktarvy in Virologically Suppressed People With HIV-1

STP-P0C-001

A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Treatment-Naïve Adults with HIV-1 Infection.

Phase III

GS-US-621-6289

An Operationally Seamless Phase 2/3 Randomized, Open-Label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People with HIV-1 on Stable Complex Treatment Regimens.

GS-US-621-6290

A Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1

GS-US-563-5926

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

GS-US-563-5925

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)

GS-US-380-6738

A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF after Discontinuing Injectable CAB + RPV Ability to receive Biktarvy with 7 days of next cabenuva dose.

Observational

TH-IBA-CTR-1003: Theratechnologies Inc. / “A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States (PROMISE-US)

The Clinical Trial Process

Clinical trials typically progress through four phases:



Phase I

Initial safety testing in a small group of participants



Phase II

Further safety assessment and early efficacy testing in a larger group



Phase III

Large-scale testing to confirm effectiveness, monitor side effects, and compare to standard treatments



Phase IV

Post-approval studies to gather additional information on the treatment’s risks, benefits, and optimal use

Participation and Safety

Your safety is our top priority. All our clinical trials:

Follow strict protocols approved by regulatory bodies
Are closely monitored by experienced medical professionals
Adhere to rigorous ethical standards

Participation is always voluntary, and you can withdraw at any time.

Learn More and Get Involved

If you’re interested in participating in a clinical trial or want to learn more about our research programs, please contact our clinical research department.

Contact James Fallon, Director of Research at

Phone: (973) 877-2663 or email jfallon@primehealthcare.com

For a complete list of our current clinical trials, visit clinicaltrials.gov and search for Saint Michael’s Medical Center.

Join us in our mission to advance medical science and improve patient care through innovative clinical research