Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Patients who have undergone heart transplantation.
To assess the prevalence of aspirin resistance in patients 12 to 18 months after heart transplantation.
Key facts
- Sponsor
- Medical University Of Vienna
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2026-05-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Department of Anaesthesia, Intensive Care Medicine and Pain Medicine
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the prevalence of aspirin resistance in patients 12 to 18 months after heart transplantation.
Secondary objectives 1
- To assess the correlation of aspirin resistance and risk factors which are described to be associated with aspirin resistance • To assess the comparability of POC platelet aggregation tests
Conditions and MedDRA coding
Patients who have undergone heart transplantation.
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521699-71-00 | Platelet function testing in outpatients after heart transplantation on aspirin therapy | Medical University Of Vienna |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients between 18 and 99 years of age
- Patients who are on aspirin therapy
- Patients who had their heart transplantation 12 to 18 months prior to the date of study inclusion
Exclusion criteria 3
- Patients with a platelet count lower than 100,000 /µL
- Patients who are pregnant
- Patients who are breast feeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Prescence of Aspirin resistance (defined via Multiplate® ASPI test)
Secondary endpoints 3
- Innovance® PFA-200 System Analyzer
- VerifyNow®
- Age, sex, BMI, active smoker, diabetes mellitus, hypertension, periods of rejection, cardiovascular events/stroke since heart transplantation, C-reactive protein (CRP), neoplasia, ICU stay after heart transplantation, CMV infection, physical activity, HDL-Cholesterol, LDL-Cholesterol, cholesterol, triglyceride
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Thrombo ASS 100 mg-Filmtabletten
PRD2842563 · Product
- Active substance
- Acetylsalicylic Acid
- Substance synonyms
- ASPIRIN, ACETYLSALICYLIC ACID (ASA), ACIDUM ACETYLSALICYLICUM
- Pharmaceutical form
- GASTRO-RESISTANT TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 100 Day(s)
- Authorisation status
- Authorised
- ATC code
- B01AC06 — ACETYLSALICYLIC ACID
- Marketing authorisation
- 1-19830
- MA holder
- G.L. PHARMA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Medical University Of Vienna
- Sponsor organisation
- Medical University Of Vienna
- Address
- Spitalgasse 23, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine
Public contact point
- Organisation
- Medical University Of Vienna
- Contact name
- Division of Cardiothoracic and Vascular Anesthesia and Intensive Care Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2025-521699-71-00 redacted | 6 |
| Protocol (for publication) | D1_Protocol EU CT 2025-521699-71-01 | 3 |
| Protocol (for publication) | D1_Protocol EU CT 2025-521699-71-01 redacted | 3 |
| Protocol (for publication) | D1_Protocol EU CT 2025-521699-71-01_redacted | 2 |
| Protocol (for publication) | D1_Protocol EU CT 2025-521699-71-01_tc | 3 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF redacted | 7 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_tc | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Thrombo ASS | 1 |
| Synopsis of the protocol (for publication) | D1 _Protocol synopsis MS de 2025-521699-71-00 | 1 |
| Synopsis of the protocol (for publication) | D1 _Protocol synopsis MS de 2025-521699-71-01 | 2 |
| Synopsis of the protocol (for publication) | D1 _Protocol synopsis MS de 2025-521699-71-01_tc | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-04 | Austria | Acceptable 2026-04-30
|
2026-05-25 |