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Acute Coronary SyndromePhase 4PLEANCT00997750

Efficacy and Safety of Lornoxicam in Patients With Acute Coronary Syndrome

A Phase 4 study testing Lornoxicam in people with Acute Coronary Syndrome, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Lornoxicam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
1 siteRussia
Study dates
Mar 2007to Jun 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Central Clinical Hospital of Presidential Department Of Russian Federation

    Moscow

Other trials in Russia

About this study

Official title: Prospective Randomized Double-center Study of Nonsteroidal Antinflammatory Drug Lornoxicam in Patients With Acute Coronary Syndrome Without Persistent ST- Segment Elevation

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.

Read the 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.

Being tested
Lornoxicam
Keywords
ACS, Acute Coronary Syndrome, NSAID, Lornoxicam, Xefocam
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LornoxicamDrug

    Also called Xefocam

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

Study groups in NCT00997750
Study groupRoleWhat they receive
LornoxicamExperimentalLornoxicam 8mg/day and 12mg/day for 15 days
Receives: Drug: Lornoxicam

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: six months

Secondary outcomes (1)

  1. Noncardiovascular death, Gastrointestinal bleeding

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2009 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2008
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997750
Sponsor's protocol ID
AB-CCH-51
Acronym
PLEA
Status last verified
Oct 2009
First submitted
18 Oct 2009
Last updated
19 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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/)

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lornoxicam in people with Acute Coronary Syndrome, run by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All Cardiovascular events (cardiovascular dearth+nonfatal miocardial infarction+unstable angina) (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00997750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.

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