NCT00997750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2007

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

1.8 years

First QC Date

October 18, 2009

Last Update Submit

October 18, 2009

Conditions

Acute Coronary Syndrome

Keywords

ACSAcute Coronary SyndromeNSAIDLornoxicamXefocam

Outcome Measures

Primary Outcomes (1)

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

    six months

Secondary Outcomes (1)

  • Noncardiovascular death, Gastrointestinal bleeding

    six months

Study Arms (1)

Lornoxicam

EXPERIMENTAL

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

Drug: Lornoxicam

Interventions

LornoxicamDRUG

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

Also known as: Xefocam
Lornoxicam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Clinical Hospital of Presidential Department Of Russian Federation

Moscow, Russia

Location

Related Publications (1)

  • 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/)

    BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

lornoxicam

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Alexei K Gruzdev, Prof

    Department of Cardiology, Central Clinical Hospital of Presidential Administration of Russian Federation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 19, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

October 19, 2009

Record last verified: 2009-10

Locations

RU(1)