Clinical trial NCT06114641: Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
Official title: Effectiveness & Safety of Ovine Enoxaparin Sodium to Originator Enoxaparin in Non-ST-Segment Elevation ACS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Safety Issues
Effect of Drug
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
First posted: 2023-11-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The non-inferiority of Ovine Enoxaparin Sodium compared to Originator enoxaparin on the proportion of death, recurrent or refractory angina, and stroke during hospitalization
timeFrame: During hospitalization or maximum within 10 days.
Secondary outcomes:
measure: 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.
timeFrame: Within 30 days post initial administration.
measure: 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.
timeFrame: During hospitalization or maximum within 10 days.
measure: The minor bleeding after Ovine Enoxaparin Sodium and Originator enoxaparin administration during hospitalization or maximum within 10 days.
timeFrame: During hospitalization or maximum within 10 days.
measure: The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-3 post initial administration
timeFrame: Day-3 post initial administration
measure: The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-6 post initial administration
timeFrame: Day-6 post initial administration
measure: The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on day-10(+7) post initial administration
timeFrame: Day-10(+7) post initial administration
measure: The thrombocytopenia events after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration
timeFrame: 30(+10) days post initial administration
measure: 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.
timeFrame: During hospitalization or maximum within 10 days.
measure: Serious adverse event after Ovine Enoxaparin Sodium and Originator enoxaparin administration on 30(+10) days post initial administration.
timeFrame: 30(+10) days post initial administration.
measure: Non-serious adverse events after Ovine Enoxaparin Sodium and Originator enoxaparin administration within 30(+10) days post initial administration.
timeFrame: 30(+10) days post initial administration.
Other outcomes:
Locations:
city: Yogyakarta
country: Indonesia
facility: RSUP Dr.Sardjito, Yogyakarta
state: D.I.Yogyakarta
city: Jakarta
country: Indonesia
facility: RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta
state: DKI Jakarta
city: Bali
country: Indonesia
facility: RSUP Prof. Dr. I.G.N.G Ngoerah, Bali
Study officials:
affiliation: Indonesian Heart Association
name: Bambang Widyantoro, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: