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

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

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Lornoxicam

Study type

Interventional

Funder types

Other

Identifiers

NCT00997750

AB-CCH-51

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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