Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients

Last updated: June 3, 2025
Sponsor: PT Bio Farma
Overall Status: Completed

Phase

4

Condition

Cardiac Disease

Chest Pain

Myocardial Ischemia

Treatment

Enoxaparin sodium injection

Clinical Study ID

NCT06114641
ENOX-0422
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with a diagnosis of non-ST-segment Elevation Acute Coronary Syndrome (NSTEACS) (unstable angina pectoris or Non-ST-Segment-Elevation myocardialinfarction (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 myocardialinfarction (NSTEMI)) based on particular diagnosis criteria

  • Subjects or legally acceptable representatives have been informed properly regardingthe study and signed the informed consent form

Exclusion

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) oractive bleeding.

  • Any severe hematologic disease or history of intracerebral mass, aneurysm,arteriovenous malformation, recent (<6 months) ischemic stroke or TIA, recent (< 6months) intracranial hemorrhage or gastrointestinal or genitourinary bleeding withinthe 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 infectiousendocarditis, hemodynamic instability, life threatening arrhythmia and cardiacarrest.

  • A recent (<48 hours) or under spinal/epidural anesthesia.

  • Platelet count below or equal to 100,000/mm3 at baseline

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: Enoxaparin sodium injection
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
August 26, 2024

Study 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.

Effectiveness:

● Number and percentage of subjects with the composite of major adverse cardiac events (MACE) including death, recurrent myocardial infarction, recurrent angina, stroke, and unplanned revascularization after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30 days post initial administration.

Safety:

  • Number and percentage of subjects with major bleeding occurring after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system.

  • Number and percentage of subjects with minor bleeding occurring after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system.

  • Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-3 post initial administration.

  • Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration.

  • Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-10(+7) post initial administration.

  • Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration at 30(+10) days post initial administration

  • Number and percentage of subjects with any serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days.

  • Number and percentage of subjects with any serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.

  • Number and percentage of subjects with non-serious adverse events after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.

Connect with a study center

  • RSUP Dr.Sardjito, Yogyakarta

    Yogyakarta, D.I.Yogyakarta
    Indonesia

    Site Not Available

  • RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta

    Jakarta, DKI Jakarta 11420
    Indonesia

    Site Not Available

  • RSUP Prof. Dr. I.G.N.G Ngoerah, Bali

    Bali, 80113
    Indonesia

    Site Not Available

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