Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
28
Countries
1
Sites
4
Atrial Fibrillation
Documented atrial fibrillation recurrences within 6 months after ECV in patients with atrial fibrillation.
Key facts
- Sponsor
- Universitaetsspital Basel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Swiss Heart Foundation · Foundation for Cardiovascular Research Basel · Swiss National Science Foundation · Machaon Foundation
External identifiers
- EU CT number
- 2024-516033-12-00
- ClinicalTrials.gov
- NCT05890664
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Documented atrial fibrillation recurrences within 6 months after ECV in patients with atrial fibrillation.
Conditions and MedDRA coding
Atrial Fibrillation
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age >18 years
- Scheduled for ECV
- ECG-documented AF prior to ECV
- Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥1 hour after ECV
- Ability and provision of written informed consent
Exclusion criteria 17
- AF persistence after cardioversion or early AF recurrence within 1 hour after ECV
- Clinically significant blood dyscrasia
- Significant immunosuppression
- Pregnant or breastfeeding womenwomen, or women of child-bearing potential who do not use a highly effective form of birth control during and 3 months following Colchicine treatment
- Life expectancy <1 year
- Prior enrolment in the COLECTRO-AF trial
- Any other rhythm than AF prior to ECV
- Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned in the next 3 months
- Known intolerance or hypersensitivity to Colchicine
- Any absolute indication for Colchicine intake
- Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein
- Serious gastrointestinal disease
- Clinically overt hepatic disease
- Severe renal disease
- Men actively attempting to father children
- Any other contraindication for Colchicine intake
- Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Documented AF recurrences within 6 months after ECV in patients with AF.
Secondary endpoints 5
- Documented AF recurrences within 1 month after ECV
- Documented AF recurrences within 3 months after ECV
- Time to first redo ECV
- Use of anti-arrhythmic drugs (Vaughan Williams class 1 or 3) at 6 months
- Survival free of unplanned hospitalization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9976516 · Product
- Active substance
- Colchicine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- M04AC01 — COLCHICINE
- Marketing authorisation
- 141381
- MA holder
- KWIZDA PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Dose was changed from 1 mg to 0.5 mg
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsspital Basel
- Sponsor organisation
- Universitaetsspital Basel
- Address
- Petersgraben 4
- City
- Basel
- Postcode
- 4031
- Country
- Switzerland
Scientific contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- COLECTRO-AF Study Team
Public contact point
- Organisation
- Universitaetsspital Basel
- Contact name
- COLECTRO-AF Study Team
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 1 | 4 |
| Rest of world
Switzerland
|
— | 27 | — |
Investigational sites
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Rhythmologie, Ratzeburger Allee 160, 23538, Luebeck
Marien Hospital Herne
Medizinische Klinik II – Kardiologie/Angiologie, Hölkeskampring 40, 44625, Herne
University Medical Center Freiburg, University Heart Center
Klinik für Kardiologie und Angiologie, Südring 15, 79189, Bad Krozingen
Herzzentrum Dresden GmbH Universitaetsklinik
Klinik für Rhythmologie, Fetscherstrasse 76, Johannstadt-Nord, Dresden
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-516033-12-00 | 3.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Bochum | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Dresden | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Freiburg | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Luebeck | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material cover letter_Bochum | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material cover letter_Dresden | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material cover letter_Freiburg | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material cover letter_Luebeck | 1 |
| Subject information and informed consent form (for publication) | L1_Schwangerschaftsbeobachtung_AKEK_v1_20260605 bochum | 1 |
| Subject information and informed consent form (for publication) | L1_Schwangerschaftsbeobachtung_AKEK_v1_20260605 freiburg | 1 |
| Subject information and informed consent form (for publication) | L1_Schwangerschaftsbeobachtung_AKEK_v1_20260605 luebeck | 1 |
| Subject information and informed consent form (for publication) | L1_Schwangerschaftsbeobachtung_AKEK_v1_20260605_dresden | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Bochum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Bochum_v2_20260605 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dresden | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Dresden_v2_20260605 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Freiburg | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Freiburg_v2_20260605 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Luebeck | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Luebeck_v2_20260605 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Colchicine0.5mg | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Germany | Acceptable with conditions 2024-11-13
|
2026-06-26 |