Rethinking Clinical Trials

DECEMBER 20, 2023

Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. There are several strategies that will help increase diversity in CVD trials. Increasing diversity in trial leadership is one of the most important strategies to increase diversity among RCT participants.

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Pharmaceutical Technology

JUNE 21, 2023

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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Rethinking Clinical Trials

JANUARY 23, 2024

Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials. RCT design will vary depending on which CAD manifestation(s) are reflected in the information provided by the imaging test being studied, which affects the treatment target(s) being evaluated in a therapeutic trial.

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Velocity Clinical Research

OCTOBER 12, 2023

Velocity is proud to unveil another groundbreaking initiative: the Cardiology Council to Accelerate Research Excellence (CARE). The proliferation of heart issues — paired with patient lifestyle factors that complicate recruitment and study design — reflect an urgent need for expert-led clinical trials.

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Pharmaceutical Technology

SEPTEMBER 26, 2022

Clinical trials were thrown into turmoil on the morning of 24 February 2022, along with every aspect of life in Ukraine. In July, approximately a third of companies had paused a trial in the country. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

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XTalks

DECEMBER 26, 2024

Menarini Group has announced positive topline data from the Phase III BROADWAY and TANDEM clinical trials, evaluating obicetrapib and the fixed-dose combination of obicetrapib with ezetimibe. Meanwhile, the TANDEM trial evaluated a fixed-dose combination of obicetrapib with 10 mg ezetimibe in a similar patient population.

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Medical Xpress

NOVEMBER 7, 2022

Levels of triglycerides are routinely measured as part of a preventive cardiology work-up and lowering triglycerides with several classes of drugs is common medical practice.

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Clinical Trial Podcast

JULY 31, 2024

Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. Sponsor(s): This podcast is brought to you by Florence Healthcare.

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Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

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CTTI (Clinical Trials Transformation Initiative)

DECEMBER 21, 2022

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies. The post It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies appeared first on CTTI.

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pharmaphorum

SEPTEMBER 1, 2024

Alnylam Pharma has been riding high since revealing top-line results from its HELIOS-B trial of vutrisiran in transthyretin-mediated amyloidosis (ATTR) – but a look at the full data seems to have disappointed investors.Shares in the company retreated after the presentation of the results at the European Society of Cardiology (ESC) conference, which (..)

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Rethinking Clinical Trials

JULY 19, 2023

The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies. This was a cluster-randomized trial of 42 cardiology clinics across the U.S.,

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XTalks

FEBRUARY 12, 2025

In key registration-enabling, placebo-controlled trials, patients received once-monthly doses of lerodalcibep for up to 52 weeks. Results from the trials demonstrated that lerodalcibep achieved significant reductions in LDL-C levels. Over 2,400 patients have continued in the 72-week open-label extension trial.

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Rethinking Clinical Trials

OCTOBER 24, 2023

REMAP-CAP is an adaptive platform trial simultaneously evaluation multiple treatments in domains using a master protocol. In adaptive trials, trial design features are modified during the trial to maximize statistical efficiency or achieve better patient outcomes. The approach definitely generated evidence more quickly.

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FDA Law Blog

NOVEMBER 10, 2024

Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2

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Medical Xpress

MAY 10, 2023

A small randomized trial in patients with post-COVID syndrome has found that hyperbaric oxygen therapy promotes restoration of the heart's ability to contract properly. The research is presented at EACVI 2023, a scientific congress of the European Society of Cardiology (ESC).

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Fierce Pharma

SEPTEMBER 1, 2024

At the European Society of Cardiology (ESC) event, Bayer unveiled data from the 3 FINEARTS-HF trial that showed Kerendia reduced the risk of cardiovascular death, as well as well as first and recurrent HF events by 16% compared to placebo in patients with mildly reduced (HFmrEF) or preserved ejection fraction (HFpEF).

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XTalks

OCTOBER 31, 2024

This includes new Phase III trial data for Kerendia (finerenone) in patients with heart failure that was presented recently at this year’s European Society of Cardiology (ESC) Congress 2024. Tune into the episode to hear more about the latest trial data for finerenone in heart failure and the landscape of heart failure research.

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STAT News

JANUARY 6, 2023

The company said it would “externalize” most of its early-stage rare disease programs in neurology and cardiology, and gene therapy programs not yet in clinical trials. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,

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XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

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Medical Xpress

MARCH 6, 2023

In staged treatment, the blocked artery that caused the heart attack is treated with a stent immediately and other partially blocked arteries are treated in a second procedure up to six weeks later.

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Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

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Medical Xpress

MARCH 8, 2023

In the largest randomized trial conducted to compare minimally invasive and conventional cardiac surgical techniques for repairing a poorly functioning mitral valve, improvements in physical activity, as well as surgical outcomes and quality of life, were similar in both groups of patients at 12 weeks post-surgery.

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pharmaphorum

APRIL 25, 2022

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. Patients in the digital arms also lost fewer days due to hospitalisation for heart failure – 1.77 days compared to 3.06

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BioTech 365

OCTOBER 2, 2020

–(BUSINESS WIRE)–The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for … Continue reading → Coronary artery disease (CAD) is a critical public health issue, affecting an estimated 16.5 million Americans1 WHIPPANY, N.J.–(BUSINESS

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Medical Xpress

FEBRUARY 21, 2023

Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinical trials, according to a study published today in the European Journal of Preventive Cardiology.

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Scienmag

AUGUST 16, 2020

Analysis lead by Penn Medicine identified gender disparities in authorship of heart failure guideline citations and clinical trials PHILADELPHIA– While about a quarter of physicians and researchers working in advanced heart failure (HF) and transplant cardiology are women, representation of women leading HF research remains limited, according (..)

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STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

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XTalks

FEBRUARY 6, 2024

Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial Management.

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XTalks

DECEMBER 2, 2024

The approval is grounded in data from five randomized, double-blind, placebo-controlled trials involving 317 adults. He expressed optimism about the therapy’s potential to enhance outcomes for patients in the US.

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Fierce Pharma

AUGUST 30, 2024

a “grand slam” with data that position its RNA silencer Amvuttra (vutrisiran) to potentially be | At the European Society of Cardiology conference in London, Alnylam presented positive data from the phase 3 HELIOS-B trial which assessed RNA silencer Amvuttra (vutrisiran) as a treatment for transthyretin amyloid cardiomyopathy (ATTR-CM).

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pharmaphorum

MARCH 9, 2021

The rationale came from the CANTOS trial where patients treated with canakinumab in atherosclerotic disease appeared to have a reduced risk of lung cancer mortality, in findings presented at the 2017 European Society of Cardiology congress.

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XTalks

NOVEMBER 26, 2024

The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. Participants were randomized to receive acoramidis or placebo over 30 months.

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Scienmag

AUGUST 31, 2020

EXPLORER-HCM trial presented in a Hot Line Session today at ESC Congress 2020 Sophia Antipolis, France – 29 Aug 2020: Mavacamten improves heart function and symptoms in patients with obstructive hypertrophic cardiomyopathy, according to results of the EXPLORER-HCM trial presented in a Hot Line session today at ESC Congress 2020.1 “The results (..)

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Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

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Rethinking Clinical Trials

APRIL 13, 2023

The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.

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Scienmag

NOVEMBER 20, 2020

AHA, ACC issue updated guidance for the evaluation and management of people with HCM The American Heart Association and the American College of Cardiology today released an updated guideline for managing patients with hypertrophic cardiomyopathy (HCM).

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