Late breaking clinical trial results from testing of cangrelor, an investigational intravenous antiplatelet, showed patients can be "bridged" from the time that their physicians stop their oral antiplatelet drugs until they undergo cardiac surgery.
Study results demonstrated cangrelor maintained target levels of platelet inhibition known to be associated with a low risk of thrombotic events, such as stent thrombosis, vs. placebo. The BRIDGE Trial results were presented here today at the Cardiovascular Research Foundation (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
"Patients with coronary stents require drugs that block platelets that can stick to their stents and cause clots. When these patients require surgery, the oral drugs must be stopped days in advance to wear off and reduce the risk of surgical bleeding; however, this puts them at an increased risk of thrombotic events," said Eric Topol, MD, cardiologist and chief academic officer at Scripps Health and BRIDGE Trial primary investigator. "With nothing available that blocks platelets and then goes away quickly, we are between the rock of thrombosis and the hard place of surgical bleeding."
The results were presented by Dominick J. Angiolillo, MD, PhD, medical director, cardiovascular research program at the University of Florida College of Medicine Jacksonville, "BRIDGE results support the hypothesis that intravenous cangrelor may be a feasible and well tolerated management strategy in patients who require prolonged platelet P2Y12 inhibition after thienopyridine discontinuation prior to cardiac surgery. Results also show control of platelet function as there was a rapid offset of platelet inhibition after stopping the cangrelor infusion prior to surgery."
According to 2009 data from the Organisation for Economic Co-operation and Development (OECD), more than 2.5 million PCIs are performed globally per year. Treatment guidelines in the United States and Europe recommend stent patients receive oral P2Y12 inhibitors for up to 12 months following percutaneous coronary intervention (PCI). It is estimated that up to 25 percent of these patients with stents in place will require a surgical procedure during the first five years after PCI.
Dimitrios Goundis, PhD, head of R&D at The Medicines Company added, "With strong patient enrollment in the Phase 3 PHOENIX trial of cangrelor in PCI patients and these results from the BRIDGE trial, there is great momentum with the cangrelor program, which is an important part of our portfolio of acute and intensive care hospital compounds."
Summary methods and resultsThe first stage of BRIDGE identified the cangrelor dose that maintains a 'thienopyridine-like' level of platelet inhibition. The second stage reported today was a prospective, randomized, double-blind, placebo-controlled trial in 210 patients with an acute coronary syndromes (ACS) or treated with a coronary stent (bare metal stent or drug eluting stent) on a thienopyridine awaiting coronary artery bypass grafting (CABG). After thienopyridine discontinuation (
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting of the cardiac catheterization laboratory including in patients undergoing PCI. In October 2010, The Medicines Company initiated a Phase 3 clinical trial called PHOENIX to evaluate cangrelor in patients undergoing PCI.
ABOUT SCRIPPS HEALTH
Founded in 1924 by philanthropist Ellen Browning Scripps, Scripps Health is a $2.3 billion nonprofit community health system based in San Diego, Calif. Scripps treats a half-million patients annually through the dedication of 2,500 affiliated physicians and 13,000 employees among its five acute-care hospital campuses, home health care services, and an ambulatory care network of physician offices and 23 outpatient centers and clinics. Scripps is also at the forefront of clinical research, genomic medicine, wireless health and graduate medical education. With three highly respected graduate medical education programs, Scripps is a longstanding member of the Association of American Medical Colleges. More information can be found at www.scripps.org.
ABOUT THE MEDICINES COMPANY
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates," "plans" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether results of clinical trials will be indicative of results in later clinical trials, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
ILA Goes Digital – Automation & Production Technology for Adaptable Aircraft Production
29.06.2020 | Fraunhofer-Gesellschaft
Special exhibition area "Microtechnologies for Optical Devices" establishes itself at W3
12.03.2020 | IVAM Fachverband für Mikrotechnik
Solar cells based on perovskite compounds could soon make electricity generation from sunlight even more efficient and cheaper. The laboratory efficiency of these perovskite solar cells already exceeds that of the well-known silicon solar cells. An international team led by Stefan Weber from the Max Planck Institute for Polymer Research (MPI-P) in Mainz has found microscopic structures in perovskite crystals that can guide the charge transport in the solar cell. Clever alignment of these "electron highways" could make perovskite solar cells even more powerful.
Solar cells convert sunlight into electricity. During this process, the electrons of the material inside the cell absorb the energy of the light....
Empa researchers have succeeded in applying aerogels to microelectronics: Aerogels based on cellulose nanofibers can effectively shield electromagnetic radiation over a wide frequency range – and they are unrivalled in terms of weight.
Electric motors and electronic devices generate electromagnetic fields that sometimes have to be shielded in order not to affect neighboring electronic...
A promising operating mode for the plasma of a future power plant has been developed at the ASDEX Upgrade fusion device at Max Planck Institute for Plasma...
Live event – July 1, 2020 - 11:00 to 11:45 (CET)
"Automation in Aerospace Industry @ Fraunhofer IFAM"
The Fraunhofer Institute for Manufacturing Technology and Advanced Materials IFAM l Stade is presenting its forward-looking R&D portfolio for the first time at...
With an X-ray experiment at the European Synchrotron ESRF in Grenoble (France), Empa researchers were able to demonstrate how well their real-time acoustic monitoring of laser weld seams works. With almost 90 percent reliability, they detected the formation of unwanted pores that impair the quality of weld seams. Thanks to a special evaluation method based on artificial intelligence (AI), the detection process is completed in just 70 milliseconds.
Laser welding is a process suitable for joining metals and thermoplastics. It has become particularly well established in highly automated production, for...
02.07.2020 | Event News
19.05.2020 | Event News
07.04.2020 | Event News
06.07.2020 | Health and Medicine
06.07.2020 | Life Sciences
06.07.2020 | Life Sciences