Release

2026-525442-30-00 Phase III and Phase IV (Integrated) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Phase III and Phase IV (Integrated)
Status Authorised, recruitment pending
Participants planned 7,000
Countries 1
Sites 2

Ischemic heart disease/Chronic coronary syndrome (Myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting)

To evaluate whether discontinuation of long-term aspirin in patients >65 years with stable chronic coronary syndrome is non-inferior to continued aspirin therapy with respect to net clinical outcome.

Key facts

Sponsor
Odense University Hospital
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Decision date (initial)
2026-07-06
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No
Funding sources
The Independent Research Fund Denmark

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

To evaluate whether discontinuation of long-term aspirin in patients >65 years with stable chronic coronary syndrome is non-inferior to continued aspirin therapy with respect to net clinical outcome.

Conditions and MedDRA coding

Ischemic heart disease/Chronic coronary syndrome (Myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. • Age ≥65 years at randomization • Ischemic heart disease with index event (MI, percutaneous coronary intervention (PCI), or coronary artery bypass grafting (CABG)) >2 years previously • Since index event free from ischemic cardiovascular events (MI, ischemic stroke, or transitory ischemic attack) or any coronary revascularization procedure (PCI/CABG) • Currently treated with low dose aspirin (≤150 mg daily, based on prescription fillings and self-reported)

Exclusion criteria 1

  1. • Any history of ischemic stroke • Active treatment with or indication for anti-coagulant or P2Y12-inhibitor therapy • Indication for antiplatelet treatment other than secondary prevention of ischemic heart disease according to treating physician (i.e. hematological diseases, peripheral artery disease) • Any revascularization procedure for peripheral artery disease • Any history of stent thrombosis or stenting of the left main coronary artery • Other contraindications to aspirin discontinuation according to treating physician • Not being able to understand Danish

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The following components are included in the primary endpoint, ranked in hierarchical order: 1. Cardiovascular death 2. Fatal bleeding (BARC type 5) 3. Intracranial bleeding (BARC type 3c) 4. Ischemic stroke 5. MI 6. Other major bleeding (BARC type 3a [moderate, requires transfusion] and 3b [major, may need surgery])

Secondary endpoints 1

  1. The secondary endpoints of the trial are listed below: - Each component of the primary composite outcome - All-cause mortality - Hospitalization for cardiovascular causes - Peptic ulcer - Patient-reported outcomes o Minor bleeding o Abdominal pain/discomfort o Quality of life o Health-related quality of life, anxiety and depressive symptoms, and functional status o Angina symptoms o Lifestyle behaviour

Investigational products

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

Test 2

Hjertemagnyl, filmovertrukne tabletter 75 mg

PRD13016344 · 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
150 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
36 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

Magnyl DAK, enterotabletter

PRD9257257 · Product

Active substance
Acetylsalicylic Acid
Substance synonyms
ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
Pharmaceutical form
GASTRO-RESISTANT TABLET
Route of administration
ORAL
Max daily dose
150 mg milligram(s)
Max total dose
150 mg milligram(s)
Max treatment duration
36 Month(s)
Authorisation status
Authorised
ATC code
N02BA01 — ACETYLSALICYLIC ACID
Marketing authorisation
13761
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

54 Total trials 29 Recruiting 12 Ended
Academic / Non-commercial
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
Axel Diederichsen

Public contact point

Organisation
Odense University Hospital
Contact name
Axel Diederichsen

Third parties 1

OrganisationCity, countryDuties
Odense University Hospital
ORG-100007716
 Odense C, Denmark On site monitoring, Data management, E-data capture, Code 8

Locations

1 EU/EEA country · 2 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Authorised, recruitment pending 7,000 2
Rest of world — 0 —

Investigational sites

Denmark

2 sites · Authorised, recruitment pending
Copenhagen University Hospital
Department of Cardiology, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Odense University Hospital
Department of Cardiology, J. B. Winsløws Vej 4, 5000, Odense

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.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2026-525442-30 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Subject information and informed consent form (for publication) L1_ICF Informed consent form 1
Subject information and informed consent form (for publication) L1_SIS Patient information 1.1
Subject information and informed consent form (for publication) L2_Other subject information material Beskrivelse af video 1.1
Subject information and informed consent form (for publication) L2_Other subject information material Henvendelsesbrev 1
Subject information and informed consent form (for publication) L2_Other subject information material Rettigheder 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Acetylsalicylsyre Carefarm Orifarm enterotabletter 75 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Acetylsalicylsyre Teva tabletter 75 mg og 150 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hjercatyl tabletter 75 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hjerdyl tabletter 75 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hjertealbyl enterotabletter 75 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hjertemagnyl filmovertrukne tabletter 150 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hjertemagnyl filmovertrukne tabletter 75 mg 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Magnyl DAK enterotabletter 100 mg 1
Synopsis of the protocol (for publication) D1_Protocol synopsis MS_2026-525442-30 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2026-04-15 Denmark Acceptable
2026-06-12
 2026-07-06

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