Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00997750

Acronym

PLEA

Enrollment

Registered

2009-10-19

Start date

2007-03-31

Completion date

2009-06-30

Last updated

2009-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

ACS, Acute Coronary Syndrome, NSAID, Lornoxicam, Xefocam

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.

Interventions

DRUGLornoxicam

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Noncardiovascular death, Gastrointestinal bleeding	six months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026