Overview
Sponsor-declared trial summary
Atrial Fibrillation (and atrial flutter), deep vein trombosis and pulmonary embolism
Compared the four NOACs head-to-head in order to evaluate the safety, efficiency and whether the four NOACs are equally effective in preventing death and hospitalizations without increasing risk of major bleeding in patients with 1) atrial fibrillaiton (and atrial flutter), and 2) in patients with deep vein trombosis o…
Key facts
- Sponsor
- Bispebjerg Hospital, 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
- 1 Apr 2023 → ongoing
- Decision date (initial)
- 2022-11-14
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Herlev and Gentofte Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
Compared the four NOACs head-to-head in order to evaluate the safety, efficiency and whether the four NOACs are equally effective in preventing death and hospitalizations without increasing risk of major bleeding in patients with 1) atrial fibrillaiton (and atrial flutter), and 2) in patients with deep vein trombosis or/and pulmonary embolism.
Secondary objectives 1
- Compare the risk of major bleedings between the four NOACs
Conditions and MedDRA coding
Atrial Fibrillation (and atrial flutter), deep vein trombosis and pulmonary embolism
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Inclusion Inclusion of patients
|
Randomised Controlled | Single | [{"id":18838,"code":2,"name":"Investigator"},{"id":18837,"code":4,"name":"Analyst"}] | Apixaban: Apixaban Edoxaban: Edoxaban Rivaroxaban: Rivaroxaban Dabigatran: Dabigatran |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- DANNOAC-AF: A diagnosis of atrial fibrillation (and atrial flutter) in outpatient clinic or as discharge diagnosis after hospitalization, and claimed prescription of a NOAC from a Danish pharmacy within 14 days of discharge or outpatient clinic visit. DANNOAC-VTE: A diagnosis of deep vein trombosis and/or pulmonary embolus in outpatient clinic or as discharge diagnosis after hospitalization. A claimed prescription of a NOAC from a Danish pharmacy within 14 days of discharge or outpatient clinic visit.
Exclusion criteria 1
- A prescription of a NOAC within 90 days prior to hospitalization.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- DANNOAC-AF: A composite endpoint of stroke, myocardial infarction, thromboembolic event or all-cause death. DANNOAC-VTE: A composite endpoint of new venous thromboembolism or all-cause death.
Secondary endpoints 1
- Individual endpoints of the primary endpoint.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB20521 · Substance
- Active substance
- Dabigatran Etexilate
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300
- Max total dose
- 150
- Max treatment duration
- 1000 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB29263 · Substance
- Active substance
- Rivaroxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20
- Max total dose
- 20
- Max treatment duration
- 1000 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32701 · Substance
- Active substance
- Edoxaban
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60
- Max total dose
- 60
- Max treatment duration
- 1000 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB25425 · Substance
- Active substance
- Apixaban
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20
- Max total dose
- 10
- Max treatment duration
- 1000 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bispebjerg Hospital
- Sponsor organisation
- Bispebjerg Hospital
- Address
- Borgmester Ib Juuls Vej 31
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Gunnar Gislason
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Gunnar Gislason
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Niels Andersens Vej 65
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Gunnar Gislason
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Gunnar Gislason
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 16,340 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-04-01 | 2023-04-01 | 2024-09-30 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-09-15 | Denmark | Acceptable 2022-11-14
|
2022-11-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-02-21 | Denmark | Acceptable 2023-03-27
|
2023-03-27 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-03-31 | Denmark | Acceptable 2023-04-18
|
2023-04-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2023-07-07 | Denmark | Acceptable 2023-07-14
|
2023-07-17 |