Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Lornoxicam

• Registration Number: NCT00997750
• Lead Sponsor: Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation

Brief Summary

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

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 Timeline

• Study Start: 2007-03
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2009-10
• Study First Submitted: 2009-10-18
• Study First Submitted QC: 2009-10-18
• Last Update Submitted: 2009-10-18
• Study First Posted: 2009-10-19
• Last Update Posted: 2009-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lornoxicam	Lornoxicam	Lornoxicam 8mg/day and 12mg/day for 15 days

Primary Outcome Measures

Name	Time	Method
All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)	six months

Secondary Outcome Measures

Name	Time	Method
Noncardiovascular death, Gastrointestinal bleeding	six months

Trial Locations

Locations (1)

Central Clinical Hospital of Presidential Department Of Russian Federation; 🇷🇺 Moscow, Russian Federation