Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

Phase 4CompletedNCT00997750

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Coronary Syndrome

Interventions

LornoxicamDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Central Clinical Hospital of Presidential Department Of Russian Federation

Moscow, Russia

Outcomes

Primary Outcomes

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

Time frame: six months

Secondary Outcomes

Noncardiovascular death, Gastrointestinal bleeding

Time frame: six months

Data from ClinicalTrials.gov

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