Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome (PLEA)
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ClinicalTrials.gov Identifier: NCT00997750 |
Recruitment Status
:
Completed
First Posted
: October 19, 2009
Last Update Posted
: October 19, 2009
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Coronary Syndrome | Drug: Lornoxicam | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
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 |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | June 2009 |
Arm | Intervention/treatment |
---|---|
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
|
- All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) [ Time Frame: six months ]
- Noncardiovascular death, Gastrointestinal bleeding [ Time Frame: six months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997750
Russian Federation | |
Central Clinical Hospital of Presidential Department Of Russian Federation | |
Moscow, Russian Federation |
Study Chair: | Alexei K Gruzdev, Prof | Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation |
Publications:
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 |
First Posted: | October 19, 2009 Key Record Dates |
Last Update Posted: | October 19, 2009 |
Last Verified: | October 2009 |
Keywords provided by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation:
ACS Acute Coronary Syndrome NSAID Lornoxicam Xefocam |
Additional relevant MeSH terms:
Syndrome Acute Coronary Syndrome Disease Pathologic Processes Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Lornoxicam Piroxicam Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |