The Colchicine and atrial fibrillation trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gentofte Hospital

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

26 May 2023 → ongoing

Decision date (initial)

2022-09-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Therapy, Efficacy

The purpose of this study is to investigate the beneficial effects of colchicine on Atrial Fibrillation and atrial flutter (henceforth under joint abbreviation as AF) recurrence in patients scheduled for electrical cardioversion for AF. We expect the results of this clinical trial to indicate whether colchicine should be repurposed for the treatment of paroxysmic/persistent AF.

Secondary objectives 3

1. To monitor the effects of Colchicine on biomarkers.
2. To monitor the effects of Colchicine on echocardiographic measurements.
3. To monitor the effects of Colchicine on life quality and side effects of Colchicine

Conditions and MedDRA coding

Atrial fibrillation or atrial flutter

Study design 1 period

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age > 18
2. Diagnosed with paroxystic/persistent AF
3. Planned or acute admission for cardioversion of AF with successful outcome
4. Female participants should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
5. Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol
6. Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator

Exclusion criteria 18

1. Colchicine treatment for another cause, e.g. gout
2. Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
3. Significant drug or alcohol abuse during the last year
4. Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
5. Planned ablation procedure as treatment for AF
6. If cardiovascular surgery or ablation has been done the past three months prior to inclusion
7. Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) or chronic diarrhea
8. Use of other investigational drugs within 30 days of the time of enrollment
9. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
10. Allergy/hypersensitivity to colchicine
11. Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
12. History of malignancy of any organ system within the last 5 years excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
13. Cirrhosis, chronic active hepatitis or other severe hepatic disease
14. Hemodialysis
15. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2
16. Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
17. Permanent AF
18. Suspected AF, confirmed with ECG, at time of inclusion and randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to first AF admission from start of medication measured in days

Secondary endpoints 4

1. Accumulated number of readmissions for symptomatic AF at 12 months
2. Change in echocardiographic measurements at 12 months
3. Change of life quality score at 12 months
4. Change in potentiel side effects at 12 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gentofte Hospital

Sponsor organisation

Gentofte Hospital

Address

Kildegaardsvej 28

City

Hellerup

Postcode

2900

Country

Denmark

Scientific contact point

Organisation

Gentofte Hospital

Contact name

Adam Femerling Langhoff

Public contact point

Organisation

Gentofte Hospital

Contact name

Adam Femerling Langhoff

Third parties 1

Sponsor responsibilities

Contact point sponsor

Gentofte Hospital

Article 77 implementation

Gentofte Hospital

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications