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

This study has been completed.
Sponsor:
Information provided by:
Central Clinical Hospital of the Presidential Administration of the Russian Federation
ClinicalTrials.gov Identifier:
NCT00997750
First received: October 18, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

October 18, 2009
October 18, 2009
March 2007
December 2008   (final data collection date for primary outcome measure)
All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) [ Time Frame: six months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Noncardiovascular death, Gastrointestinal bleeding [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome
Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: Lornoxicam
lornoxicam 8mg/day and 12mg/day for 15 days
Other Name: Xefocam
Experimental: Lornoxicam
Lornoxicam 8mg/day and 12mg/day for 15 days
Intervention: Drug: Lornoxicam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
June 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00997750
AB-CCH-51
Yes
Dr Nikita Lomakin, Central Clinical Hospital of President Department of Russian Federation
Central Clinical Hospital of the Presidential Administration of the Russian Federation
Not Provided
Study Chair: Alexei K Gruzdev, Prof Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation
Central Clinical Hospital of the Presidential Administration of the Russian Federation
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP