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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06114641
Other study ID # ENOX-0422
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2023

Study information

Verified date October 2023
Source PT Bio Farma
Contact Bambang Widyantoro
Phone +62-21-5684093
Email bambang.widyantoro@pjnhk.go.id
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date December 31, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Enoxaparin sodium injection
Originator Enoxaparin with a trade name is Lovenox.

Locations

Country Name City State
Indonesia RSUP Prof. Dr. I.G.N.G Ngoerah, Bali Bali
Indonesia RS Jantung dan Pembuluh Darah Harapan Kita, Jakarta Jakarta DKI Jakarta
Indonesia RSUP Dr.Sardjito, Yogyakarta Yogyakarta D.I.Yogyakarta

Sponsors (1)

Lead Sponsor Collaborator
PT Bio Farma

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary 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.
Secondary 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.
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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.
Secondary 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.
Secondary 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.
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