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

June 3, 2025 updated by: PT Bio Farma
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Indonesia
      • Bali, Indonesia, 80113
        • RSUP Prof. Dr. I.G.N.G Ngoerah, Bali
    • D.I.Yogyakarta
      • Yogyakarta, D.I.Yogyakarta, Indonesia
        • RSUP Dr.Sardjito, Yogyakarta
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 11420
        • RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Drug
Initial dose 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
Initial dose 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: During hospitalization or maximum within 10 days.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PT Bio Farma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bambang Widyantoro, Ph.D, Indonesian Heart Association

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 5, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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