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

NCT ID: NCT06114641

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-08-26

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.

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.

Conditions

Safety Issues; Effect of Drug

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test Drug

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

Group Type: EXPERIMENTAL

Enoxaparin sodium injection

Intervention Type: DRUG

Originator Enoxaparin with a trade name is Lovenox.

Comparator

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

Group Type: ACTIVE_COMPARATOR

Enoxaparin sodium injection

Intervention Type: DRUG

Originator Enoxaparin with a trade name is Lovenox.

Interventions

Enoxaparin sodium injection

Originator Enoxaparin with a trade name is Lovenox.

Intervention Type: DRUG

Other Intervention Names

Originator Enoxaparin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PT Bio Farma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bambang Widyantoro, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Indonesian Heart Association

Locations

RSUP Dr.Sardjito, Yogyakarta

Yogyakarta, D.I.Yogyakarta, Indonesia

RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta

Jakarta, DKI Jakarta, Indonesia

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

Bali, , Indonesia

Countries

Indonesia

Other Identifiers

ENOX-0422

Identifier Type: -

Identifier Source: org_study_id