Overview
Sponsor-declared trial summary
Acute coronary syndromes
To compare short term antiplatelet therapy to guideline dual antiplatelet therapy duration in patients with acute coronary syndromes treated with an everolimus-eluting stent for bleeding and major adverse cardiovascular or cerebrovascular events
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 13 Dec 2024 → 17 Oct 2025
- Decision date (initial)
- 2024-08-23
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To compare short term antiplatelet therapy to guideline dual antiplatelet therapy duration in patients with acute coronary syndromes treated with an everolimus-eluting stent for bleeding and major adverse cardiovascular or cerebrovascular events
Conditions and MedDRA coding
Acute coronary syndromes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All patients aged ≥18 years with acute coronary syndromes who are treated with an everolimus-eluting drug-eluting stent can undergo randomization if they can be treated with prasugrel for 12 months.
Exclusion criteria 9
- Age < 18 years
- Not able to consent to study participating (eg. intubated patients)
- Do not speak Danish
- Life expectancy <1 year
- Allergic to study related treatment
- NOAC or warfarin treatment
- Contraindication for 12 months prasugrel treatment
- Prior stroke
- Women of childbearing age, may participate in this study only if you are surgically
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Assessed between 1 and 12 months after PCI Effectiveness: Clinically relevant bleeding (BARC 2, 3 and 5 ). Powered for superiority
- Assessed between 1 and 12 months after PCI Safety: Composite major adverse cardiovascular or cerebrovascular events (MACCE) (a composite of cardiac death, myocardial infarction, definite stent thrombosis, ischemic stroke or clinically driven target lesion revascularization). Powered for non-inferiority.
Secondary endpoints 5
- Individual components of the primary end point comprised the secondary end points
- Stent thrombosis rate according to the Academic Research Consortium-2 definition
- Major bleeding (BARC type 2, 3 and 5)
- Health-related quality of life
- Angina status based on the Canadian Cardiovascular Society classification system
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Prasugrel Krka 10 mg film-coated tablets
PRD6627472 · Product
- Active substance
- Prasugrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 3355 mg milligram(s)
- Max treatment duration
- 11 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC22 — -
- Marketing authorisation
- PA1347/080/002
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Hjertemagnyl, filmovertrukne tabletter 75 mg
PRD9253051 · Product
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 25162 mg milligram(s)
- Max treatment duration
- 11 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 34891
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Lisette Okkels Jensen
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Lisette Okkels Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 3,150 | 3 |
| 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 | 2024-12-13 | 2024-12-13 | 2025-06-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-87887
- Halt date
- 2025-06-25
- Member states concerned
- Denmark
- Publication date
- 2025-06-25
- Reason
- Medicinal Product related
- Explanation
- Manufacturing error for prasugrel. The drug cannot be produced by the manufacturer. It is not known when prasugrel will be available again.
When the patients cannot redeem their prescriptions with prasugrel, we had to start treatment with ticagrelor for patient safety reasons. It is an unexpected national issue, and the same change has been performed for all patients in Denmark, also patients not enrolled in the study. - Follow-up measures
- All enrolled patients have received telephone calls. If they still have prasugrel at home they can continue in the study. There are informed to call the research staff when/if the are running out of prasugrel and they no longer can collect these tables at the pharmacy.
Patients who are switched to ticagrelor are discuntinued in the study wihtout further follow up.
As long as the study is on temporary hold, new patients will not be enrolled.
The number of subjects still receiving treatment is estimated to 50 patients, it may change when they are running out of prasugrel tablets. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Denmark | Acceptable 2024-08-23
|
2024-08-23 |