Milvexian for Acute Coronary Syndrome
(LIBREXIA-ACS Trial)
Recruiting in Palo Alto (17 mi)
+1151 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Janssen Research & Development, LLC
Must not be taking: Anticoagulants
Disqualifiers: Type 2 MI, Planned CABG, others
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial is testing a new medication called milvexian to see if it can better prevent serious heart problems like heart attacks and strokes in patients who are at high risk. The medication works by preventing blood clots, which helps keep blood flowing smoothly.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic anticoagulation therapy, you may not be eligible to participate.
Is Milvexian generally safe for humans?
Eligibility Criteria
This trial is for adults who recently had a heart-related emergency (acute coronary syndrome) with certain risk factors like being over 65, diabetes, or past heart issues. They must not need chronic blood thinners and should have no major bleeding risks or planned heart surgeries after joining the study.Inclusion Criteria
I am not pregnant, breastfeeding, nor planning to become pregnant soon after the study ends.
I am 65 or older, have diabetes, or have a history of heart issues.
I had symptoms of a heart attack and confirmed heart damage within the last week.
See 1 more
Exclusion Criteria
I haven't had significant bleeding or a bleeding disorder in the last 3 months.
I am scheduled for heart bypass surgery or a procedure to open my heart's arteries.
I am on long-term blood thinners as advised by my doctor.
See 1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 week
1 visit (in-person)
Treatment
Participants receive either milvexian or placebo, in addition to standard-of-care, to evaluate the reduction in risk of major adverse cardiovascular events
Up to 3 years 6 months
Regular visits as per study protocol
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Treatment Details
Interventions
- Milvexian (Unknown)
- Placebo (Other)
Trial OverviewThe study tests if Milvexian can better prevent serious heart problems when added to usual treatments compared to a placebo. It focuses on avoiding events like death from heart causes, new heart attacks, and strokes in patients who've just had one such event.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MilvexianExperimental Treatment1 Intervention
Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy \[SAPT\] or dual antiplatelet therapy \[DAPT\]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ascension Providence HospitalSaginaw, MI
University Cardiology GroupLubbock, TX
CIUSSS de la Mauricie-et-du-Centre-du-QuebecTrois-Rivières, Canada
University of California at San DiegoLa Jolla, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Janssen Research & Development, LLCLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
References
Adverse events in phase-I studies: a report in 1015 healthy volunteers. [2019]This report describes all clinical, laboratory and electrocardiographical adverse events detected in healthy volunteers in a phase-I centre over a 10-year period: 54 phase-I studies are involved, including 1015 healthy young volunteers (993 males) who received 1538 treatments (23 different active drugs or placebo) corresponding to 12143 days of follow-up. This updates a similar report published previously in the European Journal of Clinical Pharmacology.
Adverse events in phase one studies: a study in 430 healthy volunteers. [2019]All the clinical, laboratory and electrocardiographic adverse events detected during 24 Phase I studies in the same unit over a 5 y period are reported here. 430 healthy male volunteers were involved, corresponding to 5488 days of follow-up. The overall incidence of adverse events was 13.5%, with a significant difference between active drug (15.3%) and placebo (7.4%) treatments. There were 69 distinct types of adverse events. Headache was the most frequent symptom (2%). There were severe adverse events in 20 cases (0.36%), with an incidence of 20/430 per subject (4.6%). There were no deaths or life-threatening events. Although the main objective of Phase I studies is to determine the maximum dose tolerated, cause-effect relationships with adverse events are hard to establish, because of the frequency of adverse events with placebo, and because of the limited number of subjects included such studies.
A new model of pharmacovigilance? A pilot study. [2013]This multicenter study tested the actuation of a new model of pharmacovigilance, focused on three pharmacological wide-used categories (non-steroidal anti-inflammatory drugs, NSAID, oral anticoagulants, and antihypertensive drugs). Besides the traditional way of pharmacovigilance, an active investigation was performed, using a phone-structured interview. Patients discharged from the participating hospitals were included into the study, if their prescribed therapy included some of the above drugs and after informed consent. Three hundred subjects were interviewed, 100 for each pharmacological category. For a period of six months after patient's discharge from the hospital, a traditional pharmacovigilance survey was carried out. About 30 days after discharge from the hospital, patients were interviewed by the medical staff and data recorded. NSAID group stratification evidenced a significant percentage of severe haemorrhage among the patients who were using acetylsalicylic acid (ASA) as antiaggregant (6.8%) compared to the patients who were using non-ASA NSAID, at therapeutic dosage (1.8%). From this data, it seems that the active pharmacovigilance model was able to better highlight a real problem for the NSAID category, in particular it evidenced a pharmacological subclass (ASA) more prone to cause ADR than expected from literature data related to whole pharmacological class. Given the required economical effort, this pharmacovigilance method could take place as a selected tool when pharmacovigilance signals from the international databases become consistent or for new wide-used drugs, to screen potentially dangerous pharmacological subclasses, normally "hidden" because of a "camouflage" among ADRs of the entire pharmacological class.
The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]In contrast to the plethora of publications on placebo effects in patients, very little is known about placebo effects in healthy volunteers during clinical pharmacology studies. We therefore reviewed the adverse events spontaneously reported during placebo administration in 109 double-blind, placebo-controlled studies involving 1228 volunteers. The overall incidence of adverse events in the healthy volunteers during placebo administration was 19%. As expected, complaints were more frequent after repeated dosing (28%) and in elderly subjects (26%). Overall, the most frequent adverse events were headache (7%), drowsiness (5%), and asthenia (4%), with some variation depending on study design and population. In conclusion, these data shed new light on the impact of experimental conditions on the results of safety evaluations in healthy volunteers participating in clinical pharmacology studies.
EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]The analysis of safety data from spontaneous reporting systems has a proven value for the detection and analysis of the risks of medicines following their placement on the market and use in medical practice. EudraVigilance is the pharmacovigilance database to manage the collection and analysis of suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance first operated in December 2001, with access to the database being governed by the EudraVigilance access policy. We performed a literature search including data up to December 2016 to demonstrate how the data from EudraVigilance has been used in scientific publications. We describe the results, including by type of publication, research topics and drugs involved. In 50% of the publications, the data are used to describe safety issues, in 44% to analyse methodologies used in pharmacovigilance activities and in 6% to support clinical perspectives. We also outline a description of the use of the database by the European Union regulatory network. Driven by the full implementation of the 2010 pharmacovigilance legislation, EudraVigilance has undergone further enhancements together with a major revision of its access policy, taking into account the use of the new individual case safety report standard developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and the International Organization for Standardization. The aim of the broadened access is to facilitate more effective safety monitoring of authorised medicines, to make more data available for research and to provide better access to information on suspected adverse reactions for healthcare professionals and patients. In November 2017, the new full functionalities of EudraVigilance were launched, including the extensive web access to data on suspected adverse drug reactions and the possibilities for academic research institutions to request a more extensive dataset for the purposes of health research. The main objective of this article is to describe the new access to the database together with the opportunities that this new access can bring for research. It is intended to promote an appropriate use of the data to support the safe and effective use of medicines.