Status:
COMPLETED
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
Lead Sponsor:
PT Bio Farma
Conditions:
Safety Issues
Effect of Drug
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients
Detailed Description
To assess the non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization within 10 days....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06114641
Start Date
June 1 2023
End Date
August 26 2024
Last Update
June 6 2025
Active Locations (3)
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1
RSUP Dr.Sardjito, Yogyakarta
Yogyakarta, D.I.Yogyakarta, Indonesia
2
RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta
Jakarta, DKI Jakarta, Indonesia, 11420
3
RSUP Prof. Dr. I.G.N.G Ngoerah, Bali
Bali, Indonesia, 80113