TIMI

New VOYAGER PAD Analyses Reinforce Benefit of XARELTO® (rivaroxaban) Plus Aspirin Across High-Risk and Complex Patient Populations with Peripheral Artery Disease (PAD)

Retrieved on: 
Tuesday, November 14, 2023
ICH, Rivaroxaban, Buerger's test, Research, Safety, Johnson & Johnson, Thrombin, Food, PAD, DPI, American Heart Association, AHA, Risk, Amputation, CAD, Patient, ALI, Myocardial infarction, Intracerebral hemorrhage, Coagulation, LER, TIMI, FDA, Medical Affairs Bureau, Division, Janssen Pharmaceuticals, Comorbidity, MACE, Vascular disease, Stroke, Standard of care, University, Bleeding, Aspirin, EGFR, Janssen, Disability, Anschutz Medical Campus, Metabolism, Pharmaceutical industry

TITUSVILLE, N.J., Nov. 14, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of XARELTO® (rivaroxaban [2.5 mg twice daily plus aspirin 100 mg once daily]) over standard of care (aspirin alone). Data from the two analyses demonstrate the role of XARELTO® in treating both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD). Results were presented at the American Heart Association's (AHA) 2023 Scientific Sessions, hosted in Philadelphia, Pennsylvania, November 11-13, 2023.

Key Points: 
  • "These analyses reinforce the consistency of the favorable benefit-risk profile of XARELTO® plus aspirin for patients with vascular disease, regardless of comorbidity.
  • In fragile patients treated with XARELTO® plus aspirin, 6.2% of patients experienced a MALE compared to 10.3% of patients treated with placebo.
  • In patients with PAD only, 11% of patients treated with XARELTO® plus aspirin experienced a MACE versus 9.8% of patients treated with placebo.
  • Overall, the safety of XARELTO® plus aspirin in patients with PAD was consistent regardless of CAD with no significant interactions.

Atrial Fibrillation Study with Abelacimab Stopped Early by the Data Monitoring Committee Due to an Overwhelming Reduction in Bleeding as Compared to a DOAC (Direct Oral Anticoagulant)

Retrieved on: 
Monday, September 18, 2023
Research, General Health, Pharmaceutical, Oncology, Clinical Trials, Science, Surgery, Cardiology, Biotechnology, FDA, Other Science, Health, VTE, Bleeding, Factor XI, National Blood Clot Alliance, Medicine, Atrial fibrillation, Data monitoring committee, The New England Journal of Medicine, Stroke, Xi, DOAC, Harvard Medical School, CDC, Thrombosis, Anticoagulant, Gold, Coronary thrombosis, Patient, Myocardial infarction, Risk, Rivaroxaban, Thrombolysis, TIMI, Pravastatin or atorvastatin evaluation and infection therapy - thrombolysis in myocardial infarction 22, Hospital, Congress, MPH, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Centers for Disease Control and Prevention, Pharmaceutical industry, Brigham, MD

The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.

Key Points: 
  • The study has been stopped early by the Data Monitoring Committee due to an overwhelming reduction in the composite of major and clinically relevant non-major bleeding in patients taking abelacimab compared with patients taking rivaroxaban, a leading standard-of-care DOAC.
  • In addition, abelacimab is the first and only Factor XI inhibitor to demonstrate an unprecedented reduction in major bleeding compared to a DOAC, which is the most serious type of bleeding.
  • “The AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to the standard-of-care anticoagulant.
  • Abelacimab 150 mg maintains ~98% inhibition over the dosing interval, recapitulating the benign bleeding profile of patients with genetic Factor XI deficiency.

Merck Initiates Phase 3 Clinical Program for Oral PCSK9 Inhibitor Candidate MK-0616

Retrieved on: 
Friday, August 25, 2023
Science, Cardiology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, MSD, Myocardial infarction, Amputation, Week, Cardiovascular disease, MRK, Lipid, Merck & Co., Harvard Medical School, Hypercholesterolemia, MD, Patient, Physician, Risk, LDL, PCSK9, Thrombolysis, Buerger's test, ASCVD, Moyamoya disease, Hospital, Death, NYSE, TIMI, Stroke, Pharmaceutical industry, Medicine, Brigham, Merck

This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.

Key Points: 
  • This is the first Phase 3 clinical program for an oral PCSK9 inhibitor.
  • Merck also plans to initiate a Phase 3 cardiovascular outcomes study, CORALreef Outcomes by the end of 2023.
  • Merck is collaborating with the TIMI Study Group, a leading academic research organization for cardiovascular clinical trials, on the CORALreef Outcomes study.
  • Merck’s broad, global Phase 3 program for MK-0616 aims to enroll approximately 17,000 participants across the CORALreef Lipids, CORALreef HeFH and CORALreef Outcomes studies.

First Patient Enrolled in Phase 3 Trial Evaluating Abelacimab in High-Risk Patients with Atrial Fibrillation Deemed Unsuitable for Current Anticoagulants

Retrieved on: 
Tuesday, January 3, 2023
Thrombolysis, Clinical trial, Anticoagulant, Harvard Medical School, Stroke, Factor XI, Therapy, Hope, Health, Risk, Hemostasis, TIMI, Anthos, Patient, American Foundation for Children with AIDS, Myocardial infarction, AF, Thrombosis, Bleeding, Safety, Kidney, Rivaroxaban, Atrial fibrillation, MPH, Hospital, Pharmaceutical industry, MD, Brigham, Medicine

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that it has enrolled the first patient in LILAC-TIMI 76, a Phase 3 study to evaluate the efficacy and safety of abelacimab in high-risk patients with atrial fibrillation (AF) deemed unsuitable for current anticoagulants by their physician. The study is targeting to enroll approximately 1900 patients from more than 300 sites across North America, Europe, Latin America, and Asia.

Key Points: 
  • The study is targeting to enroll approximately 1900 patients from more than 300 sites across North America, Europe, Latin America, and Asia.
  • Data from multiple registries show that approximately 40% of AF patients are not being optimally treated todayi,” said Dan Bloomfield, M.D., Chief Medical Officer at Anthos.
  • It is an event driven phase 2b study evaluating the safety and tolerability of abelacimab compared head-to-head with rivaroxaban in 1287 patients with atrial fibrillation at moderate-to-high risk of stroke.
  • Anthos is also enrolling patients in GARDENIA, a large international patient registry designed to evaluate treatment patterns and outcomes in segments of the atrial fibrillation population that have conditions associated with an increased risk of bleeding.

Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Retrieved on: 
Tuesday, August 23, 2022
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Center for Medicare and Medicaid Innovation, Mortality, Pressure, Patient, Heart failure, CMR, Technology, CEO, Centers for Medicare & Medicaid Services, Safety, Hospital, STEMI, Medical University of Vienna, Survival, Microcirculation, PCI, Infarction, ACS, Incidence, CMS, IDE, TIMI, Myocardial infarction, Wallonia, Investigational New Drug, MVO, Multimedia, Medical school, Center, Â, FDA, Medicare, Investigational device exemption, ESC, European Heart Journal, Risk, Coronary sinus, European Society of Cardiology, Meta-analysis, Medical imaging, Pharmaceutical industry, Medical device

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology.

Key Points: 
  • Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology.
  • Miracor is currently recruiting 144 patients in PiCSO-AMI-I, a landmark European randomized controlled trial, with comparable endpoints as the approved US trial.
  • Miracor Medical was originally founded by a cardiac surgeon at the Medical University of Vienna, Austria, Professor emeritus Werner Mohl.
  • 8(1): p. 222-237
    Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study.

Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®

Retrieved on: 
Tuesday, March 29, 2022
Heart failure, Risk, Heart, DRS, Coronary sinus, Infarction, Death, Multimedia, Index, Walloon, RRR, TIMI, Myocardial infarction, Kriti Kharbanda, Teaching hospital, EFTA, EuroIntervention, PCI, Incidence, IMR, CEO, View, INT, S, Acceleration, AMI, ACS, Anatomical terms of location, STEMI, ADE, Inferior, Patient, Pharmaceutical industry, Coffee

It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.

Key Points: 
  • It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.
  • We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure."
  • In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone.
  • Furthermore, OxAMI-PICSO3 showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients.

Miracor Medical starts 2nd randomized study, targeting expanded indications. 300 patients have been treated with PiCSO®

Retrieved on: 
Tuesday, March 29, 2022
Heart failure, Risk, Heart, DRS, Coronary sinus, Infarction, Death, Walloon, Index, RRR, TIMI, Myocardial infarction, Kriti Kharbanda, Teaching hospital, EFTA, EuroIntervention, PCI, Incidence, IMR, CEO, INT, S, Acceleration, AMI, ACS, Anatomical terms of location, STEMI, ADE, Inferior, Patient, Pharmaceutical industry, Coffee

It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.

Key Points: 
  • It will explore the potential for PiCSO therapy to improve the outcomes of patients with heart attacks affecting the inferior side of the heart.
  • We know that improving outcomes for patients with large heart attacks remains an important unmet need, especially because these patients often progress to develop heart failure."
  • In the study, patients will be randomized 2:1 to a group receiving PiCSO as an adjunct to their primary PCI procedure versus a conventional strategy of primary PCI alone.
  • Furthermore, OxAMI-PICSO3 showed an early improvement in coronary microvascular function post PiCSO treatment in both anterior and inferior STEMI patients.

HeartBeam Establishes Scientific Advisory Board and Appoints C. Michael Gibson, MD as Chairman

Retrieved on: 
Thursday, January 27, 2022
Health, Medical Devices, Technology, Telecommunications, Software, Cardiology, Hardware, Coronary artery disease, Coronavirus Scientific Advisory Board (Turkey), Risk, Board of directors, Result, Physician, Forward-looking statement, TIMI, Financial condition report, Cardiology, Board, Research, Prevalence, Thienopyridine, Medicine, Technology, Cardiovascular disease, Time, Leadership, Infarction, 3D, NASDAQ, Doctor of Philosophy, Twitter, Rivaroxaban, Arrhythmia, ECG, Patient, SAB, Thomson Reuters, Form, Director, Fondaparinux, MD, Founder, Â, MI, Analysis, Pharmaceutical industry, Medical device

In conjunction, world-renowned cardiologist C. Michael Gibson, MS, MD, was appointed as Chairman of the new SAB.

Key Points: 
  • In conjunction, world-renowned cardiologist C. Michael Gibson, MS, MD, was appointed as Chairman of the new SAB.
  • Dr. Gibson has been a leading investigator in trials of thrombolytic agents, glycoprotein 2b3a inhibitor agents, thienopyridines, factor Xa inhibitors, lipid-lowering agents and new devices.
  • Dr. Gibson was named one of the worlds most widely published and cited scientists of past decade in 2018 - 2021 by Thomson Reuters.
  • HeartBeam is initially focusing on a huge unmet need of helping diagnose heart attacks in patients outside of a medical institution.

New Data Demonstrates Safety and Performance of Continuous Aspiration Thrombectomy with Penumbra’s Indigo® System CAT™ RX Catheter in High-Risk Patients with Acute Coronary Syndrome

Retrieved on: 
Friday, November 5, 2021
Cardiology, Biotechnology, Surgery, General Health, Health, Medical Devices, Clinical Trials, Other Health, Myocardial infarction, Columbia University Irving Medical Center, TIMI, Safety, TCT, Șaeș, CAT, Medicine, Culture, Perfusion, MBG, Heart, Security (finance), Thrombus, Technology, Failure, Trial of the century, Investment, MACE, Use, COVID-19, Multimedia, Stroke, Annual report, PCI, Twitter, Contraindication, Percutaneous coronary intervention, Incidence, Manatee Memorial Hospital, Hospital, U.S. Securities and Exchange Commission, NYHA, Columbia University, LinkedIn, SEC, Nature, NYSE, Physician, Time, Joe Byrd (Cherokee Nation Principal Chief), Patient, Reperfusion, Acute coronary syndrome, Cardiogenic shock, Pharmaceutical industry, Risk management, the CHEETAH Study, Penumbra, THE CHEETAH STUDY, PENUMBRA

After only one pass with Penumbras CAT RX, we were pleased to see restoration of blood flow and perfusion when used upfront in acute coronary syndrome interventions.

Key Points: 
  • After only one pass with Penumbras CAT RX, we were pleased to see restoration of blood flow and perfusion when used upfront in acute coronary syndrome interventions.
  • The CHEETAH clinical study enrolled 400 patients with high thrombus burden who were treated with continuous mechanical aspiration thrombectomy with CAT RX prior to PCI.
  • As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
  • The CHEETAH study suggests that CAT RX power aspiration is both safe and effective in a high-risk coronary patient population.

NewAmsterdam Pharma Reports Positive Results from Phase 2 Study of Oral Obicetrapib Demonstrating Over 50% LDL-Lowering as an Adjunct to High-Intensity Statins

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Cardiology, Medical specialties, Clinical medicine, Drugs, Organofluorides, Cardiology, TIMI, Statin, Low-density lipoprotein, Ezetimibe, Cholesteryl ester transfer protein, Bempedoic acid/ezetimibe, Gemigliptin

NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.

Key Points: 
  • NAP is developing obicetrapib as an adjunct to maximally tolerated lipid-lowering therapy as a monotherapy and a fixed-dose combination with ezetimibe.
  • Top-line results of the ROSE study show unprecedented effects of CETP inhibition on LDL-c reduction and HDL-c increase attributed to orally administered obicetrapib.
  • ROSE (NCT04753606) was designed as a placebo-controlled, double-blind, randomized, Phase 2 dose-finding study to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to high-intensity statin therapy.
  • A total of 120 patients were randomized to placebo, 5 mg obicetrapib or 10 mg obicetrapib for an 8-week treatment period.