CeleCor Therapeutics announced positive topline results from its Phase 3 CeleBrate trial evaluating Disaggpro™ (zalunfiban) for heart attack treatment. The study met its primary efficacy and safety endpoints. Disaggpro, a next-generation GPIIb/IIIa inhibitor, is designed for rapid pre-hospital administration via subcutaneous injection in ST-segment elevation (STEMI) heart attacks. The full results will be presented at the American Heart Association Scientific Sessions in November. The CeleBrate trial enrolled 2,467 patients across multiple countries to assess the safety and efficacy of Disaggpro in the pre-hospital setting for STEMI patients.
Cardiovascular diseases (CVDs) represent the number one cause of all mortalities globally, with heart attacks being a major contributor to this burden. According to the World Health Organization, 17 million people die every year from cardiovascular diseases, particularly heart attacks and strokes.
Of these global cardiovascular deaths, 7.6 million are specifically attributed to heart attacks (myocardial infarctions), while 5.7 million are due to stroke. The impact is particularly severe in Europe, where more than half of all deaths are caused by CVDs.
A 2024 study highlights that coronary artery disease (CAD) is increasing globally, now accounting for a third of all deaths worldwide. Myocardial infarctions represent the most severe clinical manifestation of CAD and are among the most dangerous coronary events.
Historical data from 1999 indicated that the incidence of acute myocardial infarction (AMI) showed large regional differences that couldn't be completely explained by classical risk factors. At that time, the 28-day case fatality of AMI remained unacceptably high at 50% on average, despite improved therapeutic possibilities.
Time trends in mortality from ischemic heart disease (IHD) have shown a decrease in most Western European countries and an increase in Eastern Europe. Despite this geographic variation, cardiovascular diseases remain the worldwide leading cause of mortality according to 2024 data.
It's worth noting that 80% of premature deaths from cardiovascular causes could be avoided by controlling the main risk factors: tobacco, unhealthy diet and physical inactivity. Research from the Vienna Transdanube Aging Study (VITA) found that a history of cerebral and cardiovascular events or smoking was significantly associated with the appearance of CVDs. Both smoking (p = 0.0005, OR 1.57, 95% CI 1.22-2.03) and previous CVDs (p = 0.0003, OR 2.36, 95% CI 1.49-3.76) greatly increase the risk for further cerebral and cardiovascular events, particularly in persons over 75 years.
Acute myocardial infarction is complicated by cardiac rupture in 4% to 24% of all infarction deaths, and approximately 10% of hospital infarction deaths. Nearly one in three patients with acute myocardial infarction had other diagnoses at first medical contact, resulting in less frequent guideline-indicated care and significantly higher mortality rates.
Despite considerable progress in prevention and treatment, a 1999 publication predicted that the incidence and prevalence of IHD would increase in the future due to aging of the population, a trend that appears to be continuing based on more recent data.
Based on a thorough examination of available research data, there appears to be a significant gap in comprehensive statistics regarding the completion rates for clinical trials focused on heart attacks (myocardial infarction) initiated within the past decade (2013-2023).
Similarly, the specific causes for trial abandonment or early termination in myocardial infarction studies are not well documented in the current literature. This represents an important area for future research and systematic review.
The lack of consolidated data on completion metrics and abandonment factors specifically for heart attack trials highlights a potential blind spot in our understanding of clinical research efficiency in this critical medical field.
Researchers and funding agencies would benefit from more transparent reporting and analysis of trial completion patterns and termination reasons to improve future study designs and increase the likelihood of successful completion of cardiovascular clinical trials.
Without reliable statistics on these aspects, it remains challenging to identify and address the systemic issues that may be hindering the successful completion of heart attack research, potentially delaying important therapeutic advances for patients suffering from this life-threatening condition.
Future initiatives to track and analyze trial progression metrics specifically for cardiovascular research could provide valuable insights for improving research protocols and resource allocation in this vital area of medical science.
This double-blind, placebo-controlled, randomized clinical trial with 10,584 patients showed:
Significantly reduced total major adverse cardiovascular events (MACE) by 23%
Reduced myocardial infarction rate (1.8 vs 2.7 events per 100 person-years)
Reduced stroke rate (1.2 vs 1.8 events per 100 person-years)
Efficacy outcomes:
Significantly lower NT-proBNP levels at 1 month and beyond
Improved mitral regurgitant jet area and mitral regurgitant volume
Significant reductions in left ventricular volumes and improvement in ejection fraction
Lower rate of heart failure hospitalization (HR = 2.03)
Efficacy outcomes:
Significantly higher incidence of blush score ≥ 2 (71% vs. 38%)
Better complete ST-segment resolution (71% vs. 44%)
No slow flow/no-reflow phenomenon or reperfusion arrhythmia in the PIO group
Trend toward better improvement of LVEF (48% vs. 41%) and lower peak CK levels