Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

Acute Coronary Syndrome Clinical Trial

— PLEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997750
• Other study ID #: AB-CCH-51
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2009
• Last updated: October 18, 2009
• Start date: March 2007
• Est. completion date: June 2009

Study information

• Verified date: October 2009
• Source: Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Lornoxicam
lornoxicam 8mg/day and 12mg/day for 15 days

Locations

Country	Name	City	State
Russian Federation	Central Clinical Hospital of Presidential Department Of Russian Federation	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati

Country where clinical trial is conducted

Russian Federation, 

References & Publications (1)

Lomakin N.V., Gruzdev A.K. Cardiovascular risks of cyclooxygenase inhibitors (data review). Kardiol serdecno-sosud hir #1:28-36, 2009 (http://www.mediasphera.ru/journals/cardsurg/530/eng/8095/)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)		six months	No
Secondary	Noncardiovascular death, Gastrointestinal bleeding		six months	Yes