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

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Lornoxicam
Sponsored by
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, Acute Coronary Syndrome, NSAID, Lornoxicam, Xefocam

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Central Clinical Hospital of Presidential Department Of Russian Federation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lornoxicam

Arm Description

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

Outcomes

Primary Outcome Measures

All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)

Secondary Outcome Measures

Noncardiovascular death, Gastrointestinal bleeding

Full Information

First Posted
October 18, 2009
Last Updated
October 18, 2009
Sponsor
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT00997750
Brief Title
Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome
Acronym
PLEA
Official Title
Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
ACS, Acute Coronary Syndrome, NSAID, Lornoxicam, Xefocam

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lornoxicam
Arm Type
Experimental
Arm Description
Lornoxicam 8mg/day and 12mg/day for 15 days
Intervention Type
Drug
Intervention Name(s)
Lornoxicam
Other Intervention Name(s)
Xefocam
Intervention Description
lornoxicam 8mg/day and 12mg/day for 15 days
Primary Outcome Measure Information:
Title
All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)
Time Frame
six months
Secondary Outcome Measure Information:
Title
Noncardiovascular death, Gastrointestinal bleeding
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexei K Gruzdev, Prof
Organizational Affiliation
Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation
Official's Role
Study Chair
Facility Information:
Facility Name
Central Clinical Hospital of Presidential Department Of Russian Federation
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Citations:
Citation
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/)
Results Reference
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Learn more about this trial

Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

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