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Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention (OPTIENOX-PCI)

NCT03145675 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2022-10-12

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Enoxaparin (Staged-dose PCI Group)

Enoxaparin 0.5+0.25 mg/kg administered intravenously.

DRUG

Enoxaparin (Single-dose PCI Group)

Enoxaparin 0.75 mg/kg administered intravenously.

DRUG

Enoxaparin (High-dose Group)

Enoxaparin 0.75 mg/kg administered intravenously.

DRUG

Enoxaparin (Standard-dose Group)

Enoxaparin 0.5 mg/kg administered intravenously.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhenyu Liu, M.D. · Department of Cardiology, Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2022-04-20
Completion
2022-07-14

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145675 on ClinicalTrials.gov