Comparing Ovine Enoxaparin Sodium to Standard Enoxaparin in Heart Patients
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients in Multicenter, Non-randomized, Open-label, Non-inferiority Trial
This study is testing if a new type of blood thinner called Ovine Enoxaparin Sodium is just as safe and effective as the standard version for heart patients with a specific condition.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | PT Bio Farma Industry-sponsored |
| Locations | 3 sites (Yogyakarta, D.I.Yogyakarta and 2 other locations) |
| Trial ID | NCT06114641 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of Ovine Enoxaparin Sodium compared to the standard enoxaparin in patients with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS). It is a multicenter, non-randomized, open-label trial that aims to determine if Ovine Enoxaparin Sodium is non-inferior in preventing major adverse cardiac events during hospitalization. The study will assess outcomes such as death, recurrent angina, stroke, and bleeding events within a specified timeframe after administration. Participants will be monitored for various safety and effectiveness metrics over a 30-day period.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS), including unstable angina or NSTEMI.
Not a fit: Patients currently using other anticoagulants or with severe hematologic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and equally effective alternative to standard enoxaparin for patients with NSTEACS.
How similar studies have performed: While this approach is being evaluated for the first time in this specific context, similar studies have shown promise in comparing alternative anticoagulants.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects with a diagnosis of non-ST-segment Elevation Acute Coronary Syndrome (NSTEACS) (unstable angina pectoris or Non-ST-Segment-Elevation myocardial infarction (NSTEMI)) based on particular diagnosis criteria * Subjects with a diagnosis of non-ST-segment Elevation Acute Coronary Syndrome (NSTEACS) (unstable angina pectoris or Non-ST-Segment-Elevation myocardial infarction (NSTEMI)) based on particular diagnosis criteria * Subjects or legally acceptable representatives have been informed properly regarding the study and signed the informed consent form Exclusion Criteria: * Subject concomitantly enrolled or scheduled to be enrolled in another study. * Subjects use any other anticoagulant agent. * Hemoglobin level below or equal to 9 mg/dl (for male) and 8.5 mg/dl (for female) or active bleeding. * Any severe hematologic disease or history of intracerebral mass, aneurysm, arteriovenous malformation, recent (\<6 months) ischemic stroke or TIA, recent (\< 6 months) intracranial hemorrhage or gastrointestinal or genitourinary bleeding within the past 2 weeks. * History of allergy or hypersensitivity to enoxaparin heparin or its derivatives, including other low molecular weight heparins (LWMH). * History of Heparin type II-induced thrombocytopenia (HIT). * Have severe renal failure (Creatinine Clearance below 15 mL/min), acute infectious endocarditis, hemodynamic instability, life threatening arrhythmia and cardiac arrest. * A recent (\<48 hours) or under spinal/epidural anesthesia. * Platelet count below or equal to 100,000/mm3 at baseline
Where this trial is running
Yogyakarta, D.I.Yogyakarta and 2 other locations
- RSUP Dr.Sardjito, Yogyakarta — Yogyakarta, D.I.Yogyakarta, Indonesia (Recruiting)
- RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta — Jakarta, DKI Jakarta, Indonesia (Recruiting)
- RSUP Prof. Dr. I.G.N.G Ngoerah, Bali — Bali, Indonesia (Recruiting)
Study contacts
- Study coordinator: Bambang Widyantoro
- Email: bambang.widyantoro@pjnhk.go.id
- Phone: +62-21-5684093
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.