Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
2,700
Countries
1
Sites
5
Myocardial infarction
This trial aims to improve existing dual antiplatelet therapy (DAPT) routines by assessing if patients with myocardial infarction, who are at high bleeding risk, can be safely allocated to an individualized, de-escalated DAPT strategy with clopidogrel using Cytochrome P2C19-genotyping and shorter duration of DAPT to re…
Key facts
- Sponsor
- Rigshospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Jun 2022 → ongoing
- Decision date (initial)
- 2022-04-27
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500125-32-00
- ClinicalTrials.gov
- NCT05262803
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacogenetic
This trial aims to improve existing dual antiplatelet therapy (DAPT) routines by assessing if patients with myocardial infarction, who are at high bleeding risk, can be safely allocated to an individualized, de-escalated DAPT strategy with clopidogrel using Cytochrome P2C19-genotyping and shorter duration of DAPT to reduce bleedings without increasing the risk of ischemic events.
Secondary objectives 1
- The secondary objectives are to evaluate different bleeding types, all-cause and cause-specific mortality, different ischemic events, adherence and compliance to treatment, pharmacoeconomics, and self-reported quality of life according to the treatment arms.
Conditions and MedDRA coding
Myocardial infarction
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Dan-DAPT The Dan-DAPT trial is an investigator-initiated, multicenter, multi-arm, open-label, randomized, superiority (for BARC type 2-5 non-access site bleeding), and non-inferiority trial (for NACE) that will include patients with MI treated with PCI at Rigshospitalet, Skejby, Odense, Aalborg, Roskilde and Gentofte hospitals in Denmark from 2022-2025. The participants will be randomized 1:1:1 to standard-of-care, genotype-guided DAPT, and shorter genotype-guided DAPT. As some patients are randomized to genotype-guided DAPT, treatment cannot be blinded.
|
Randomised Controlled | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Inclusion criteria: 1. MI caused by atherothrombotic CAD (Type 1 MI) according to “The Fourth Universal Definition of MI”, which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value >99th percentile and at least one of the following criteria assessed by the treating physician: • symptoms indicating acute myocardial ischemia • new ischemic changes on the electrocardiogram • development of pathological Q-waves • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology • visible coronary thrombus by angiography 2. PRECISE-DAPT score ≥25 3. Age ≥18 years
Exclusion criteria 1
- 1. Contraindications including allergies to ASA or P2Y12 inhibitors 2. Indication for oral anticoagulation 3. Previous stent thrombosis 4. Life expectancy <1 year 5. Resuscitated cardiac arrest with Glasgow Coma Scale <8 and/or need of intubation 6. Prior intracranial hemorrhage 7. Active bleeding (BARC ≥2) at randomization 8. Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception 9. Hypertensive crisis (systolic blood pressure >180 mmHg and/or diastolic blood pressure >120 mmHg) 10. Unable to understand and follow study-related instructions or to comply with study protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary composite endpoints are: • The NACE (net adverse clinical events) endpoint is a composite of all-cause mortality, recurrent myocardial infarc, definite stent thrombosis, ischemic stroke, and BARC type 3-5 non-access site bleedings after 12 months • Bleeding Academic Research Consortium (BARC) type 2-5 non-access site bleeding after 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
Brilique 90 mg film-coated tablets
PRD3534050 · Product
- Active substance
- Ticagrelor
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 32940 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC24 — -
- Marketing authorisation
- EU/1/10/655/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel "Krka", filmovertrukne tabletter
PRD6625999 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 915 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- 59328
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel Mylan 10 mg film-coated tablets
PRD9281411 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1830 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- EU/1/18/1273/002
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel Mylan 5 mg film-coated tablets
PRD9281410 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 915 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- EU/1/18/1273/001
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel "Krka", filmovertrukne tabletter
PRD6626000 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1830 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- 59329
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel Teva 5 mg Film-coated Tablets
PRD5960121 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 915 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- PL 00289/2165
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Efient 5 mg film-coated tablets.
PRD3500939 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 915 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- EU/1/08/503/001
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prasugrel Teva 10 mg Film-coated Tablets
PRD5938263 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1830 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- PL 00289/2166
- MA holder
- TEVA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Efient 10 mg film-coated tablets.
PRD3500948 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1830 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- EU/1/08/503/008
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12730MIG · Substance
- Active substance
- Acetylsalicylic Acid
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 27375
- Max treatment duration
- 365 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13395MIG · Substance
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 13688 mg milligram(s)
- Max treatment duration
- 6 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
Rigshospitalet
- Sponsor organisation
- Rigshospitalet
- Address
- Blegdamsvej 9
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Rigshospitalet
- Contact name
- Rikke Sorensen
Public contact point
- Organisation
- Rigshospitalet
- Contact name
- Rikke Sorensen
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Institut For Klinisk Medicin Aarhus Universitet ORG-100026606
|
Aarhus N, Denmark | Other |
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | Other |
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | Other |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 2,700 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Aarhus University Hospital
Cardiology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Aalborg University Hospital
Cardiology, Hobrovej 18/22, 9000, Aalborg
Rigshospitalet
Cardiology, Blegdamsvej 9, 2100, Copenhagen Oe
Zealand University Hospital
Cardiology, Sygehusvej 10, 4000, Roskilde
Odense University Hospital
Cardiology, J B Winsloews Vej 4, 5000, Odense C
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 | 2022-06-20 | 2022-06-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D1_ Protocol 2022-500125-32-00_tracked changes | 4 |
| Protocol (for publication) | Appendix III Quality of life questionaries EQ 5D 5L | 1 |
| Protocol (for publication) | Appendix IV Statistical analysis plan | 1 |
| Protocol (for publication) | D1_ Protocol 2022-500125-32-00 | 4 |
| Protocol (for publication) | Protocol | 3 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 2 |
| Subject information and informed consent form (for publication) | Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS 2022-500125-32-00 | 3 |
| Subject information and informed consent form (for publication) | Samtykkeerklring | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Acetylsalicylic acid SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Brilique SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Clopidogrel SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Prasugrel SPC | 1 |
| Synopsis of the Protocol - Extract (for publication) | D1_Protocol synopsis Danish 2022-500125-32-00_tracked changes | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Danish 2022-500125-32-00 | 4 |
| Synopsis of the protocol (for publication) | Protokolresume | 3 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-02-15 | Denmark | Acceptable 2022-04-25
|
2022-04-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-24 | Denmark | Acceptable 2024-07-15
|
2024-07-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-30 | Denmark | Acceptable 2024-07-15
|
2024-12-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-23 | Denmark | Acceptable 2025-11-18
|
2025-11-18 |