Clinical Trials Register

Summary
EudraCT Number:	2017-003836-35
Sponsor's Protocol Code Number:	2017-001-COPAF
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2018-06-20
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-003836-35

A.3

Full title of the trial

Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF)

Colchicina para la prevención de la fibrilación auricular perioperatoria en pacientes sometidos a cirugía torácica (COP-AF)

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery

Colchicina para la prevención de la fibrilación auricular perioperatoria en pacientes sometidos a cirugía torácica

A.3.2

Name or abbreviated title of the trial where available

COP-AF

A.4.1

Sponsor's protocol code number

2017-001-COPAF

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03310125

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1201-2656

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Population Health Research Institute
B.1.3.4	Country	Canada
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Hamilton Health Sciences Corporation
B.4.2	Country	Canada
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital de la Santa Creu i Sant Pau
B.5.2	Functional name of contact point	Dr Ekaterine Popova
B.5.3	Address:
B.5.3.1	Street Address	Sant Antoni Mª Claret 167
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08025
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034935537808 / 7814
B.5.5	Fax number	0034935537809
B.5.6	E-mail	EPopova@santpau.cat

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Colchicine Tiofarma 0.5mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Tiofarma BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Colchicine 0.5mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Colchicine
D.3.9.1	CAS number	64-86-8
D.3.9.3	Other descriptive name	COLCHICINE
D.3.9.4	EV Substance Code	SUB01420MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Colchicine Teva 0.5mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Teva Nederland BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Colchicine 0.5mg
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Colchicine
D.3.9.1	CAS number	64-86-8
D.3.9.3	Other descriptive name	COLCHICINE
D.3.9.4	EV Substance Code	SUB01420MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Perioperative atrial fibrillation / atrial flutter after thoracic surgery

Fibrilación / aleteo auricular perioperatorio después de la cirugía torácica

E.1.1.1

Medical condition in easily understood language

Fast irregular heartbeats in patients after thoracic surgery

Latidos cardíacos rápidos e irregulares en pacientes después de cirugía torácica

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10003662
E.1.2	Term	Atrial flutter
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10003658
E.1.2	Term	Atrial fibrillation
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective of this trial is to determine whether the administration of colchicine compared with placebo reduces the occurrence of clinically important perioperative AF within 14 days of randomization.

El objetivo principal de este ensayo es determinar si la administración de colchicina en comparación con placebo reduce la aparición de FA perioperatoria clínicamente importante dentro de los 14 días posteriores a la aleatorización.

E.2.2

Secondary objectives of the trial

The secondary trial objectives are to determine whether the administration of colchicine compared with placebo reduces the:
1. first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization;
2. duration of stay in ICU, step-down, and in-hospital;
3. all-cause mortality within 14 days of randomization;
4. occurrence of myocardial infarction within 14 days of randomization;
5. occurrence of myocardial injury after noncardiac surgery (MINS); and
6. time to chest tube removal within 14 days of randomization.

Los objetivos secundarios del ensayo son determinar si la administración de colchicina en comparación con placebo reduce lo siguiente:
1. Primera incidencia de mortalidad por cualquier causa, infarto de miocardio no fatal o accidente cerebrovascular no fatal en los 14 días posteriores a la aleatorización;
2. Duración de la estancia en la UCI y en la sala la hospitalización convencional;
3. Mortalidad por cualquier causa en los 14 días posteriores a la aleatorización;
4. Incidencia de infarto de miocardio en los 14 días posteriores a la aleatorización;
5. Incidencia de lesión miocárdica tras una cirugía no cardiaca; y
6. Tiempo hasta la extracción del tubo torácico en los 14 días posteriores a la aleatorización.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are ≥55 years of age at the time of randomization.

Todos los pacientes sometidos a cirugía torácica con anestesia general son elegibles para el ensayo si tienen ≥55 años de edad al momento de la aleatorización.

E.4

Principal exclusion criteria

We will exclude patients who meet any of the following criteria:
1. Patients with a prior history of documented AF;
2. Patients currently taking anti-arrhythmic medication;
3. Patients undergoing minor thoracic interventions/procedures;
4. Patients with contraindications to colchicine;
5. Patients not expected to take oral medications for >24 hours after surgery;
6. Patients scheduled for lung transplantation;
7. Patients currently taking non-study colchicine before surgery;
8. Patients with severe hepatic dysfunction;
9. Patients with aplastic anemia,
10. Women of childbearing age who are not taking an effective form of birth control,
11. Patients who took within the last 14 days or scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole; OR
12. HIV patients treated with antiretroviral therapy.

Excluiremos pacientes que cumplan con alguno de los siguientes criterios:
1. Pacientes con antecedentes de FA documentada;
2. Pacientes que actualmente toman medicamentos antiarrítmicos distintos de los betabloqueantes, bloqueadores de los canales de calcio o digoxina;
3. Pacientes sometidos a intervenciones / procedimientos torácicos menores;
4. Pacientes con contraindicaciones para colchicina;
5. Pacientes que no tienen previsto tomar medicación oral durante >24 horas tras la cirugía;
6. Pacientes programados para un trasplante de pulmón;
7. Pacientes que actualmente toman colchicina ajena al estudio antes de la cirugía;
8. Pacientes con disfunción hepática severa;
9. Pacientes con anemia aplástica;
10. Las mujeres en edad fértil que no están tomando una forma efectiva de control de natalidad;
11. Pacientes que tomaron en los últimos 14 días o tienen previsto tomar durante los primeros 10 días después de la cirugía, claritromicina, eritromicina, telitromicina, ciclosporina, ketoconazol o itraconazol; O
12. Pacientes con VIH tratados con terapia antirretroviral.

E.5 End points

E.5.1

Primary end point(s)

Clinically important perioperative atrial fibrillation (AF), defined as AF developing after randomization until the end of follow-up, and that results in angina, heart failure, symptomatic hypotension, or that requires treatment with a rate controlling drug, antiarrhythmic drug or electrical cardioversion.

Fibrilación auricular (FA) perioperatoria clínicamente importante, definida como una FA que se desarrolla después de la aleatorización hasta el final del seguimiento y que provoca angina, insuficiencia cardíaca, hipotensión sintomática o que requiere tratamiento con un fármaco que controla el ritmo cardiaco, antiarrítmico o cardioversión eléctrica .

E.5.1.1

Timepoint(s) of evaluation of this end point

Evaluation at 14 days after randomization.

Evaluación a los 14 días después de la aleatorización.

E.5.2

Secondary end point(s)

1. time to first occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke within 14 days of randomization;
2. between group comparison of duration of stay in ICU, step-down, and in-hospital;
3. time to all-cause mortality within 14 days of randomization;
4. time to occurrence of myocardial infarction within 14 days of randomization;
5. time to occurrence of myocardial injury after noncardiac surgery (MINS); and
6. time to chest tube removal within 14 days of randomization.

1. Tiempo hasta la primera aparición del compuesto de mortalidad por cualquier causa, infarto de miocardio no fatal o accidente cerebrovascular no fatal en los 14 días posteriores a la aleatorización;
2. Comparación grupal de la duración de la estancia en la unidad de cuidados intensivos (UCI), en la sala la hospitalización convencional y del ingreso hopitalario;
3. Tiempo hasta la aparición de mortalidad por cualquier causa en los 14 días posteriores a la aleatorización;
4. Tiempo hasta la aparición del infarto de miocardio dentro de los 14 días posteriores a la aleatorización;
5. tiempo hasta la aparición de una lesión miocárdica después de una cirugía no cardíaca (MINS); y
6. tiempo hasta la extracción del tubo torácico dentro de los 14 días de la aleatorización.

E.5.2.1

Timepoint(s) of evaluation of this end point

Evaluation at 14 days after randomization.

Evaluación a los 14 días después de la aleatorización.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

Hong Kong

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

980

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1820

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

2800

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Nada

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-08-17

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-25

P. End of Trial
P.	End of Trial Status	Ongoing

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