CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 378 enrolled
Drug / intervention
Enoxaparin (Staged-dose PCI Group) +3 moredrug
Likely dose
Enoxaparin (Staged-dose PCI Group) 0.25 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03145675
NCT03145675Phase 4Completed
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Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention

Peking Union Medical College Hospital·interventional·Posted May 9, 2017·Updated Oct 12, 2022

In Brief

A Phase 4 clinical trial evaluating Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group), and 2 other interventions for Coronary Artery Disease and Percutaneous Coronary Intervention. Completed, enrolled 378 participants across 1 site.

Detailed Summary

The OPTIENOX-PCI is a single-center, prospective, randomized, open-label, controlled study, which is designed to assess the anticoagulation profile of: 1) High-dose (0.75 mg/kg) vs. Standard-dose (0.5 mg/kg) enoxaparin; 2) Staged-dose (0.5+0.25 mg/kg) vs. Single-dose (0.75 mg/kg) enoxaparin in about 376 patients who plan to undergo elective trans-radial coronary angiography (CAG) with or without subsequent percutaneous coronary intervention (PCI).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease, Percutaneous Coronary Intervention
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedMay 9, 2017
Enrollment StartMay 12, 2017
Primary CompletionApr 20, 2022
Study CompletionJul 14, 2022
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.1 years ago

Interventions

Enoxaparin (Staged-dose PCI Group)drug

Enoxaparin 0.5+0.25 mg/kg administered intravenously.

Enoxaparin (Single-dose PCI Group)drug

Enoxaparin 0.75 mg/kg administered intravenously.

Enoxaparin (High-dose Group)drug

Enoxaparin 0.75 mg/kg administered intravenously.

Enoxaparin (Standard-dose Group)drug

Enoxaparin 0.5 mg/kg administered intravenously.