Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome (PLEA)
This study has been completed.
Sponsor:
Central Clinical Hospital of the Presidential Administration of the Russian Federation
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
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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:
- 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
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00997750
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 March 01, 2015