UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016185
Receipt number R000018786
Scientific Title Effects of low dose colchicine on endothelial function in patients with coronary heart diseases
Date of disclosure of the study information 2015/01/13
Last modified on 2015/01/12 11:57:58

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of low dose colchicine on endothelial function in patients with coronary heart diseases

Acronym

Low dose colchicine and endothelial function

Scientific Title

Effects of low dose colchicine on endothelial function in patients with coronary heart diseases

Scientific Title:Acronym

Low dose colchicine and endothelial function

Region

Japan


Condition

Condition

Patients with stable coronary artery disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of our study is a translational research of colchicine, which already has long history as an anti-gout drug, for the development as an anti-atherosclerotic drug. The present study will examine effects of multiple dose (7 days) of colchicine on endothelial function in patients with coronary artery diseases in a cross over design as a pilot study for pre-phase III study evaluating effects of colchicine on endothelial function in RCT under the ICH-GCP.

Basic objectives2

Pharmacodynamics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Endothelial function measured by FMD.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Colchicine at 0.5mg per day for 1 week

Interventions/Control_2

Placebo

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

1) Patients with coronary artery disease with condition being stable for previous 6 months.
2) Aged 20 years and over and less than 70 years old
3) Patients who voluntarily give informed consent after full explanation of the study

Coronary artery disease is defined as 1)significant stenosis (>AHA 75% ) of coronary arteries by CAG or coronary artery CT 2) history of PCI or CABG 3) history of acute coronary syndrome

Key exclusion criteria

1) Patients aged 70 and over and less than 20 years old
2) Patients receiving drugs interacting with colchicine through CYP3A4 and p-glycoprotein listed in the label.
3) Patients with impaired renal function being eGFR less than 30ml/min/1.73m2
4) Patients with liver cirrhosis
5) Patients with cholestasis
6) Patients with active malignant tumor
7) Patients who are expected mothers or on breast feeding.
8) Inappropriate patients for this study judged by doctors in charge.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Ueda

Organization

University of the Ryukyus

Division name

Department of Clinical Pharmacology & Therapeutics

Zip code


Address

207 Uehara, Nishiharacho, Okinawa, Japan

TEL

0988951195

Email

blessyou@med.u-ryukyu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichiro Ueda

Organization

University of the Ryukyus

Division name

Department of Clinical Pharmacology & Therapeutics

Zip code


Address

207 Uehara, Nishiharacho, Okinawa, Japan

TEL

0988951195

Homepage URL


Email

blessyou@med.u-ryukyu.ac.jp


Sponsor or person

Institute

University of the Ryukyus

Institute

Department

Personal name



Funding Source

Organization

Grant-in-aid for scientific research from Ministry of health, labor and welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Tokyo Medical University, HIroshima University

Name of secondary funder(s)

N/A


IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

琉球大学(沖縄県),東京医科大学(東京都)、広島大学(広島県)


Other administrative information

Date of disclosure of the study information

2015 Year 01 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2014 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 15 Day

Last follow-up date

2015 Year 09 Month 30 Day

Date of closure to data entry

2015 Year 11 Month 30 Day

Date trial data considered complete

2015 Year 12 Month 31 Day

Date analysis concluded

2016 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 12 Day

Last modified on

2015 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018786


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name