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

NCT06114641 | Completed Phase 4 DMC

• 1 other identifier: ENOX-0422
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 3

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

Conditions

Safety Issues; Effect of Drug

Outcome Measures

Primary Outcomes (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

  Number and precentage non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization

  During hospitalization or maximum within 10 days.

Secondary Outcomes (10)

• The composite of 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.

  Within 30 days post initial administration.

• The major bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days using BARC scoring system during hospitalization or maximum within 10 days.

  During hospitalization or maximum within 10 days.

• The minor bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days.

  During hospitalization or maximum within 10 days.

• The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-3 post initial administration

  Day-3 post initial administration

• The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration

  Day-6 post initial administration

Study Arms (2)

Test Drug

EXPERIMENTAL

Initial dose 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours

Drug: Enoxaparin sodium injection

Comparator

ACTIVE COMPARATOR

Initial dose 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours

Drug: Enoxaparin sodium injection

Interventions

Enoxaparin sodium injection DRUG

Originator Enoxaparin with a trade name is Lovenox.

Also known as: Originator Enoxaparin

Comparator; Test Drug

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PT Bio Farma: lead

Study Sites (3)

RSUP Dr.Sardjito, Yogyakarta

Yogyakarta, D.I.Yogyakarta, Indonesia

Location

RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta

Jakarta, DKI Jakarta, 11420, Indonesia

Location

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

Bali, 80113, Indonesia

Location

MeSH Terms

Interventions

enoxaparin sodium

Study Officials

• Bambang Widyantoro, Ph.D

  Indonesian Heart Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 2, 2023
• Study Start: June 1, 2023
• Primary Completion: February 5, 2024
• Study Completion: August 26, 2024
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

ID (3)