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

Safety Issues Clinical Trial

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

Status Recruiting

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Effect of Drug
• Safety Issues

• NCT number: NCT06114641
• Study type: Interventional
• Source: PT Bio Farma
• Contact: Bambang Widyantoro
• Phone: +62-21-5684093
• Email: bambang.widyantoro@pjnhk.go.id
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2023
• Completion date: December 31, 2023