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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997750
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 19, 2009
Sponsor:
Information provided by:
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Lornoxicam Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : June 2009
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Noncardiovascular death, Gastrointestinal bleeding [ Time Frame: six months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. High risk of bleeding of any location
  2. Any kind of acute and active inflammatory process (excluding acute coronary syndrome)
  3. Aspirin or NSAID Intolerability
  4. No informed consent
  5. Acute peptic stomach or duodenum ulcer
  6. Acute or chronic renal failure (serum creatinin >300 mmol/l)
  7. Acute cerebrovascular bleeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997750


Locations
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Russian Federation
Central Clinical Hospital of Presidential Department Of Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Investigators
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Study Chair: Alexei K Gruzdev, Prof Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation
More Information
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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/)

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Responsible Party: Dr Nikita Lomakin, Central Clinical Hospital of President Department of Russian Federation
ClinicalTrials.gov Identifier: NCT00997750    
Other Study ID Numbers: AB-CCH-51
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 19, 2009
Last Verified: October 2009
Keywords provided by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation:
ACS
Acute Coronary Syndrome
NSAID
Lornoxicam
Xefocam
Additional relevant MeSH terms:
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Acute Coronary Syndrome
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