Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome (PLEA)

This study has been completed.

Sponsor:

Information provided by:

Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati

ClinicalTrials.gov Identifier:

NCT00997750

First received: October 18, 2009

Last updated: NA

Last verified: October 2009

History: No changes posted

Purpose

The purpose of this study is to determine whether nonsteroidal antiinflammatory drug lornoxicam in combination with low dose aspirin (100mg/day) is effective and safe in patients with Acute Coronary Syndrome without persistent ST-segment elevation.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Lornoxicam	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation

Further study details as provided by Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati:

Primary Outcome Measures:

All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Noncardiovascular death, Gastrointestinal bleeding [ Time Frame: six months ] [ Designated as safety issue: Yes ]


Enrollment:	85
Study Start Date:	March 2007
Study Completion Date:	June 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lornoxicam Lornoxicam 8mg/day and 12mg/day for 15 days	Drug: Lornoxicam lornoxicam 8mg/day and 12mg/day for 15 days Other Name: Xefocam

Detailed Description:

Nonsteroidal Antiinflammatory drugs (NSAIDs) are the most frequently prescribed drugs in the world. There are a lot of controversial information published during recent years about NSAID cardiosafety. It is still unclear do NSAIDs develop cardioprotective or cardiotoxic effects in acute and chronic heart disease patients. Aim of the study was to investigate safety and efficacy of Lornoxicam, nonselective COX-inhibitor, in patients with acute coronary syndrome without ST-segment elevation (NSTEACS) and to evaluate the influence of Lornoxicam on C-reactive protein (CRP) and IL-6, IL-10 levels.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Unstable angina verified during first 48 hours after admitting to the hospital or
Acute Miocardial infarction without St-segment elevation verified during first 48 hours after admitting to the hospital

Exclusion Criteria:

High risk of bleeding of any location
Any kind of acute and active inflammatory process (excluding acute coronary syndrome)
Aspirin or NSAID Intolerability
No informed consent
Acute peptic stomach or duodenum ulcer
Acute or chronic renal failure (serum creatinin >300 mmol/l)
Acute cerebrovascular bleeding

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00997750

Locations


Russian Federation
Central Clinical Hospital of Presidential Department Of Russian Federation
Moscow, Russian Federation

Sponsors and Collaborators

Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati

Investigators


Study Chair:	Alexei K Gruzdev, Prof	Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation

More Information

Publications:

Lomakin N.V., Gruzdev A.K. Cardiovascular risks of cyclooxygenase inhibitors (data review). Kardiol serdecno-sosud hir #1:28-36, 2009 (http://www.mediasphera.ru/journals/cardsurg/530/eng/8095/)


Responsible Party:	Dr Nikita Lomakin, Central Clinical Hospital of President Department of Russian Federation
ClinicalTrials.gov Identifier:	NCT00997750 History of Changes
Other Study ID Numbers:	AB-CCH-51
Study First Received:	October 18, 2009
Last Updated:	October 18, 2009
Health Authority:	Russia: Ministry of Health of the Russian Federation

Keywords provided by Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati:


ACS Acute Coronary Syndrome NSAID Lornoxicam Xefocam

Additional relevant MeSH terms:


Syndrome Acute Coronary Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Lornoxicam Piroxicam Anti-Inflammatory Agents, Non-Steroidal	Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016

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