Evaluating Vericiguat in Patients with Acute Coronary Syndrome and Low Ejection Fraction
Effect of Vericiguat on Endpoint Events in ACS Patients With Ejection Fraction <45%：a Prospective Preventional Clinical Study
This study is testing if the medication vericiguat can improve heart health and quality of life for people with acute coronary syndrome and low heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06321094 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of vericiguat, a soluble guanylate cyclase stimulator, on patients with acute coronary syndrome (ACS) and an ejection fraction of less than 45%. It aims to determine whether regular administration of vericiguat leads to differences in key cardiovascular outcomes compared to those who do not receive the medication. The study will collect data on cardiovascular death, heart failure hospitalizations, inflammatory markers, NT-proBNP levels, echocardiogram results, and quality of life scores. By analyzing these endpoints, researchers hope to clarify the potential benefits of vericiguat in this high-risk patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with acute coronary syndrome and an ejection fraction of less than 45%.
Not a fit: Patients with severe hepatic or renal insufficiency, or those with a life expectancy of less than one year due to malignancy or other conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new insights into the management of acute coronary syndrome in patients with reduced ejection fraction, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on vericiguat in heart failure populations, this specific application in ACS patients with low ejection fraction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Provide written informed consent for the trial. * 2.Has acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction \[NSTEMI\], or ST elevation myocardial infarction \[STEMI\]) or coronary revascularization (coronary artery bypass grafting \[CABG\] or percutaneous coronary intervention \[PCI\]). * 3.ejection fraction \<45%. * 4.Be male or female, aged greater than18 and less than 90 on the day of signing informed consent. Exclusion Criteria. * 1.SBP\<100mmHg. * 2.Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the trial. * 3.Has severe hepatic insufficiency or renal insufficiency. * 4.Has malignancy or other non-cardiac condition limiting life expectancy to \<1 years.
Where this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: LianSheng Wang
- Email: drlswang@njmu.edu.cn
- Phone: 13390787111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.