Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Lornoxicam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lornoxicam<br>Lornoxicam 8mg/day and 12mg/day for 15 days | Drug: Lornoxicam<br>* lornoxicam 8mg/day and 12mg/day for 15 days<br>* Other names: Xefocam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Noncardiovascular death, Gastrointestinal bleeding |  | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACS, Acute Coronary Syndrome, NSAID, Lornoxicam, Xefocam