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Completed

NCT Number: NCT00997750

Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Central Clinical Hospital of Presidential Department Of Russian Federation

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lornoxicam

Drug

lornoxicam 8mg/day and 12mg/day for 15 days

Other names: Xefocam

Primary outcomes

  1. All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)

    Time frame: six months

Secondary outcomes

  1. Noncardiovascular death, Gastrointestinal bleeding

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Other Gov

Registry information

Official study title

Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation

Acronym: PLEA

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Oct 19, 2009
Registry last updated
Oct 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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