Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elev… (NCT06114641) | Clinical Trial Compass
CompletedPhase 4
Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
Indonesia220 participantsStarted 2023-06-01
Plain-language 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
Who can participate
Age range18 Years – 65 Years
SexALL
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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 und…
What they're measuring
1
The non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization
Timeframe: During hospitalization or maximum within 10 days.