Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Lornoxicam

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

Group Type EXPERIMENTAL

Lornoxicam

Intervention Type DRUG

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

Interventions

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Lornoxicam

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

Intervention Type DRUG

Other Intervention Names

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Xefocam

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No