Advertisement

Topics

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

2017-05-10 13:53:22 | BioPortfolio

Summary

The OPTIENOX-PCI is a randomized study, which is designed to assess the anticoagulation profile of different dose regimens of enoxaparin, i.e., 0.5 mg/kg, 0.75 mg/kg, and 0.5 mg/kg with additional 0.25 mg/kg, in about 120 patients who plan to undergo elective trans-radial coronary angiography with or without subsequent PCI.

Description

After eligible patients are randomized into Planned Staged-dose Group and Planned Single-dose Group, first-dose anticoagulation will be administered immediately. All patients in the Planned Staged-dose Group will receive enoxaparin 0.5 mg/kg at the beginning of coronary angiography and only those with definite indication for subsequent PCI will be given additional enoxaparin 0.25 mg/kg at the beginning of PCI; while, all patients in the Planned Single-dose Group will receive enoxaparin 0.75 mg/kg at the beginning of coronary angiography irrespective of their indication for subsequent PCI. Blood samples for the measurement of Anti-Xa activity will be obtained at 0 min (immediately before first-dose administration), 10 min, 90 min, 180 min after first-dose administration in all patients. Additional blood samples for Anti-Xa assessment will be collected only in patients undergoing subsequent PCI immediately before and at 10 min after the beginning of PCI, as well as at the end of PCI. The primary objective of the present study is to obtain the values of Anti-Xa activity at the above time points in each group of patients. In patients who undergo subsequent PCI, the proportion of patients with therapeutic anticoagulation (Anti-Xa 0.5-1.8 IU/ml) at 10 min after the beginning of PCI and at 90 min after first-dose administration will be compared respectively between the two groups (Staged-dose PCI Group [0.5+0.25 mg/kg] versus Single-dose PCI Group [0.75 mg/kg]). In patients who do not undergo subsequent PCI, the proportion of patients with therapeutic anticoagulation at 10 min and 90 min after first-dose administration will be compared respectively between the two groups (High-dose Group [0.75 mg/kg] versus Standard-dose Group [0.5 mg/kg]).

In conclusion, the OPTIENOX-PCI study will 1) obtain the Anti-Xa activity of enoxaparin at each time point of sampling; 2) assess the anticoagulation profile of high- versus standard-dose enoxaparin (0.75 mg/kg vs. 0.5 mg/kg), as well as that of staged- versus single-administration of high-dose enoxaparin (0.5+0.25 mg/kg vs. 0.75 mg/kg). The result of the present study will provide pharmacodynamical data for the design of future outcome studies.

Study Design

Conditions

Coronary Artery Disease

Intervention

Enoxaparin (Staged-dose PCI Group), Enoxaparin (Single-dose PCI Group), Enoxaparin (High-dose Group), Enoxaparin (Standard-dose Group)

Location

Peking Union Medical College Hospital
Beijing
Beijing
China
100730

Status

Not yet recruiting

Source

Peking Union Medical College Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-05-10T13:53:22-0400

Clinical Trials [12079 Associated Clinical Trials listed on BioPortfolio]

Residual Anti-Xa Activity After Last Treatment Dose of Enoxaparin

The main objective of this study is to determine the time interval following the last treatment dose of enoxaparin at which the amount of anti-Xa level activity is reliably less than 0.2IU...

Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients

The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction an...

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Single, Escalating Doses of PER977 Following a Single Dose of Enoxaparin

PER977 administration following a single subcutaneous (sc) dose of enoxaparin 1.5 mg/kg will have an acceptable safety and tolerability profile with no impact on pro-coagulant biomarkers.

Addition of Enoxaparin to Neoadjuvant Chemoradiation of Esophageal Cancer

This is a randomized, single blind, multi-center, phase two clinical trial. Inclusion criteria are consist of non-metastatic esophageal cancer who are going to receive chemo-radiotherapy. ...

Taxotere-Enoxaparin-(ENOXA)-Study

Taxotere-Enoxaparin-(ENOXA)-Study: 1st-Line Docetaxel-Platin Chemotherapy as single therapy or in combination with Enoxaparin in patients aged older than 18 years with locally advanced or ...

PubMed Articles [21883 Associated PubMed Articles listed on BioPortfolio]

Enoxaparin overdose in a newborn.

Enoxaparin is a low molecular weight heparin used in the neonatal period. It requires less monitoring than standard or unfractionated heparin, although current knowledge about its dose and therapeutic...

Pharmacokinetics of Enoxaparin After Renal Transplantation in Pediatric Patients.

Enoxaparin is commonly used in the prevention of renal allograft vascular thrombosis but off-label in children, and no consensus exists regarding the optimal dosing and dose adjustment. In this retros...

Development of a method to analyze the complexes of enoxaparin and platelet factor 4 with size-exclusion chromatography.

Heparin, a highly sulfated glycosaminoglycan, has been used as a clinical anticoagulant over 80 years. However, heparin-induced thrombocytopenia and thrombosis (HITT) is a serious side effect of hepar...

The effect of pre-operation (125)I seed activity measuring on dose accuracy.

To measure the activity of (125)I seed and compare the dose difference of ten patients treated with seed implantation in pre-plan with actual seed activity and calibrate activity. The activity of 100...

Pharmacodynamic Effects of a 6-Hour Regimen of Enoxaparin in Patients Undergoing Primary Percutaneous Coronary Intervention (PENNY PCI Study).

Delayed onset of action of oral P2Y inhibitors in ST-elevation myocardial infarction (STEMI) patients may increase the risk of acute stent thrombosis. Available parenteral anti-thrombotic strategies, ...

Medical and Biotech [MESH] Definitions

The dose amount of poisonous or toxic substance or dose of ionizing radiation required to kill 50% of the tested population.

A treatment schedule in which the total dose of radiation is divided into large doses.

Mice selectively bred for hypersusceptibility to two-stage chemical skin carcinogenesis. They are also hypersusceptible to UV radiation tumorigenesis with single high-dose, but not chronic low-dose, exposures. SENCAR (SENsitive to CARcinogenesis) mice are used in research as an animal model for tumor production.

The highest dose of a biologically active agent given during a chronic study that will not reduce longevity from effects other than carcinogenicity. (from Lewis Dictionary of Toxicology, 1st ed)

Administration of the total dose of radiation (RADIATION DOSAGE) in parts, at timed intervals.

More From BioPortfolio on "Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention (OPTIENOX-PCI)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Radiology
Radiology is the branch of medicine that studies imaging of the body; X-ray (basic, angiography, barium swallows), ultrasound, MRI, CT and PET. These imaging techniques can be used to diagnose, but also to treat a range of conditions, by allowing visuali...


Searches Linking to this Trial