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

Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients in Multicenter, Non-randomized, Open-label, Non-inferiority Trial

The aim of this study is evaluating safety and effectiveness of Ovine Enoxaparin Sodium in Non-ST-Segment Elevation Acute Coronary Syndrome (NSTEACS) Patients

Study Overview

• Status: Recruiting
• Conditions: Safety Issues; Effect of Drug
• Intervention / Treatment: Drug: Enoxaparin sodium injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Bambang Widyantoro; Phone Number: +62-21-5684093; Email: bambang.widyantoro@pjnhk.go.id

Study Locations

• Indonesia
  • Bali, Indonesia, 80113
    • Recruiting
    • RSUP Prof. Dr. I.G.N.G Ngoerah, Bali
    • Contact: I. Made Artha, Dr.; Phone Number: +62-361-227912; Email: sae_enoxtrial@googlegroups.com
  • D.I.Yogyakarta
    • Yogyakarta, D.I.Yogyakarta, Indonesia
      • Recruiting
      • RSUP Dr.Sardjito, Yogyakarta
      • Contact: Hendry Purnasidha Bagaswoto, MD; Phone Number: (0274) 631190; Email: sae_enoxtrial@googlegroups.com
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 11420
      • Recruiting
      • RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta
      • Contact: Dafsah Arifa Juzar, Dr.; Phone Number: (021) 5684093; Email: sae_enoxtrial@googlegroups.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control; Enoxaparin will be given for 3 to 8 days or until clinically stable as per its current approval for use in UA and NSTEMI. The minimum duration of therapy will be 3 days; however, catheterization and PCI can be scheduled earlier than this time as indicated. Initial 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours	Drug: Enoxaparin sodium injection; Originator Enoxaparin with a trade name is Lovenox.; Other Names: Originator Enoxaparin
Active Comparator: Comparator; Originitaro Enoxaparin will be given for 3 to 8 days or until clinically stable as per its current approval for use in UA and NSTEMI. Initial 30 mg IV loading dose is administered and followed by 1 mg/kg subcutaneously every 12 hours	Drug: Enoxaparin sodium injection; Originator Enoxaparin with a trade name is Lovenox.; Other Names: Originator Enoxaparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Number and precentage of the 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.	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.	Number and precentage of subjects with major bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration 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.	Number and precentage of subjects with 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	Number and percentage of subjects with 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	Number and precentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration	Day-6 post initial administration
The 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 on day-10(+7) post initial administration	Day-10(+7) post initial administration
The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration	Number and percentage of subjects with thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration	30(+10) days post initial administration
Serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days 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 During hospitalization or maximum within 10 days	During hospitalization or maximum within 10 days.
Serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration.	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 on 30(+10) days post initial administration.	30(+10) days post initial administration.
Non-serious adverse events 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.	30(+10) days post initial administration.

Collaborators and Investigators

• Sponsor: PT Bio Farma

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Enoxaparin; Enoxaparin sodium
• Other Study ID Numbers: ENOX-0422

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No