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

This study has been completed.
Sponsor:
Information provided by:
Central Clinical Hospital of the Presidential Administration of the Russian Federation
ClinicalTrials.gov Identifier:
NCT00997750
First received: October 18, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome
Drug: Lornoxicam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation

Further study details as provided by Central Clinical Hospital of the Presidential Administration of the Russian Federation:

Primary Outcome Measures:
  • All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Noncardiovascular death, Gastrointestinal bleeding [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 85
Study Start Date: March 2007
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lornoxicam
Lornoxicam 8mg/day and 12mg/day for 15 days
Drug: Lornoxicam
lornoxicam 8mg/day and 12mg/day for 15 days
Other Name: Xefocam

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00997750

Locations
Russian Federation
Central Clinical Hospital of Presidential Department Of Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Central Clinical Hospital of the Presidential Administration of the Russian Federation
Investigators
Study Chair: Alexei K Gruzdev, Prof Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation
  More Information

No publications provided

Responsible Party: Dr Nikita Lomakin, Central Clinical Hospital of President Department of Russian Federation
ClinicalTrials.gov Identifier: NCT00997750     History of Changes
Other Study ID Numbers: AB-CCH-51
Study First Received: October 18, 2009
Last Updated: October 18, 2009
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Central Clinical Hospital of the Presidential Administration of the Russian Federation:
ACS
Acute Coronary Syndrome
NSAID
Lornoxicam
Xefocam

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Lornoxicam
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014