Efficacy and Safety of Lornoxicam in Patients With Acute... | NCT00997750

Studies
Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

NCT00997750

Sponsor

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

Status

Completed

Last Update Posted

Oct 19, 2009Estimated

Enrollment

85Actual

Phase

Phase 4

Conditions

Acute Coronary Syndrome

Interventions

Lornoxicam

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Jun 2009Actual

First Submitted Date

Oct 18, 2009

First Submission Date that Met QC Criteria

Oct 18, 2009

First Posted Date

Oct 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2009

Last Update Posted Date

Oct 19, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian FederationOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lornoxicam	Experimental	Lornoxicam 8mg/day and 12mg/day for 15 days	Drug: Lornoxicam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lornoxicam	Drug	lornoxicam 8mg/day and 12mg/day for 15 days	Lornoxicam

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina)		six months

Secondary Outcomes

Measure	Description	Time Frame
Noncardiovascular death, Gastrointestinal bleeding		six months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexei K Gruzdev, Prof	Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Clinical Hospital of Presidential Department Of Russian Federation		Moscow			Russia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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/)

Type	Date	Date Unknown
Release	Aug 11, 2011
Unrelease		Yes

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases