Overview

Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients: a Multicenter, Non-randomized, Open-label, Non-inferiority Trial

Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PT Bio Farma
Treatments:
Enoxaparin
Enoxaparin sodium
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