NCT02095522

Brief Summary

Colchicine has antiinflammatory properties. It has been shown to be effective in improving outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to assess the effect of colchicine on endothelial function using the EndoPATâ„¢ in NSTEMI Patients. Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients who were in treated with colchicine versus the placebo group Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an informed consent. Primary outcome will be the improvement in endothelial function between baseline and after 1 month in both groups

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 7, 2016

Status Verified

July 1, 2016

Enrollment Period

1.8 years

First QC Date

March 6, 2014

Last Update Submit

July 6, 2016

Conditions

NSTEMI

Keywords

colchicine NSTEMI endothelial function inflammation

Outcome Measures

Primary Outcomes (1)

  • Improvement of RH-PAT at 1 month (a marker of endothelial function)

    RH-PAT will be measured before the angiography and after one month.

    1 month

Secondary Outcomes (10)

  • Improvement in inflammatory biomarkers (before cardiac catheterization, after cardiac catheterization and at 1 month time follow-up)

    1 month

  • Improvement in endothelial function markers.

    1 month

  • inflammatory biomarkers Improvement of heart rate variability (HRV)

    1 month

  • Changes in cholinergic status

    1 month

  • Reduction of Acute Kidney Injury post PCI

    1 month

  • +5 more secondary outcomes

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 1mg per day for one month

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Placebo 1mg per day

Drug: Placebo

Interventions

ColchicineDRUG

Colchicine 1mg per day for one month

Colchicine
PlaceboDRUG

Placebo

Also known as: Placebo tablet 1mg per day for a month
Placebo

Eligibility Criteria

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

You may qualify if:

  • NSTEMI Diagnosis
  • Patients above the age of 18
  • Informed consent

You may not qualify if:

  • Hemodynamic instability
  • Pregnant women
  • Peripheral vascular disease with feeble or absent peripheral pulses
  • Restlessness and/or chaotic breathing
  • Renal dialysis
  • Severe aortic valve insufficiency/Stenosis
  • Severe mitral valve insufficiency
  • Congenital cardiac malformations (structural heart diseases)
  • Known extra-cardiac shunts
  • Major surgery within 30 days
  • Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
  • Known intolerance to colchicine
  • Ejection fraction less than 35% or past admission for CHF exacerbation in the last 30 days.
  • Inflammatory diseases
  • Current treatment with steroids, NSAID, chemotherapy or biologic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tel Aviv Medical Center

Tel Aviv, Israel, 64329, Israel

Location

Sourasky medical center (Ichilov)

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Yaron Arbel, MD

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tel-Aviv Medical Center

Study Record Dates

First Submitted

March 6, 2014

First Posted

March 24, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 7, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(2)