Adaptation Dose of Enoxaparin in Moderate Renal Failure Patients With Acute Coronary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the VALIDE study is to validate that a 25% dose reduction of enoxaparine in patients with moderate renal failure (creatinine clearance between 30 and 50 ml/min) and hospitalized for an acute coronary syndrome provides at steady state a similar anti Xa level in plasma compared to that obtained in patients without renal failure and receiving the usual dose of 1 mg/kg subcutaneously every 12 hours. 140 per - protocol patients are planned to be included.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Renal PRotection Against Contrast mEdium-induced nephroPathy in High Risk Patients undErgoing Coronary Angiography

NCT02463604

Renal Insufficiency Contrast Medium-induced Renal Insufficiency

COMPLETED NA

Prevention of Acute Kidney Injury in Patients With NSTEMI

NCT04912141

Non-ST Elevation Myocardial Infarction (NSTEMI)

TERMINATED PHASE2

Renal Effect of Pentoxyphylline in High Risk Patients Undergoing Angiography

NCT01144091

Contrast Induced Nephropathy Diabetes Mellitus

WITHDRAWN NA

Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

NCT03121053

Aortic Valve Disease Chronic Kidney Disease Contrast Induced Nephropathy +1 more

UNKNOWN PHASE4

Reduce Bolus Injection of Bivalirudin

NCT03588611

Acute Coronary Syndrome

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Included patients will be those hospitalized for an acute coronary syndrome with indication of enoxaparin treatment. A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min. After the fourth dose, the anti-Xa plasma levels (main endpoint) will be measured at peak (between 3 and 5 hours after dose administration). Residual values of antiXa will also be measured before the fifth dose administration (secondary criteria).

The objective is to demonstrate a bio-equivalence of efficacy on the anti-Xa values obtained in patients with moderate rela failure compared with patients with creatinine clearance higher than 50 ml/min.

Thrombotic and bleeding events will be recorded during hospitalisation. 140 per-protocol evaluable consecutive patients will have to be obtained: 70 with creatinine clearance higher than 50 ml/min and 70 patients with creatinin clearance between 30 and 50 ml/min.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Coronary Syndrome Renal Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

dose adaptation of Enoxaparine at the renal deficient patients

Group Type EXPERIMENTAL

dose adaptation of Enoxaparin

Intervention Type DRUG

A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.

2

No dose adaptation of Enoxaparine at renal normal patients

Group Type ACTIVE_COMPARATOR

normal injection of Enoxaparine

Intervention Type DRUG

No dose adaptation of Enoxaparine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dose adaptation of Enoxaparin

A same initial dose of 1 mg/kg will be administrated to all patients. According to creatinine clearance, the next doses (every 12 hours subcutaneously) will be adjusted with a 25% dose reduction if creatinine clearance is comprised between 30 and 50 ml/min.

Intervention Type DRUG

normal injection of Enoxaparine

No dose adaptation of Enoxaparine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients hospitalized for acute coronary syndrome
* Indication of enoxaparin treatment
* Informed consent

Exclusion Criteria

* Myocardial infarction with ST elevation
* Inclusion later than 12 hours after the first enoxaparin dose administration
* Creatinine clearance lower than 30 ml/min
* History of thrombopenia induced by heparin
* Platelet count lower than 100.000 / mm3
* Age \< 18
* Pregnancy
* History of hemorrhagic stroke
* Contra-indication to enoxaparin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No