Overview
Sponsor-declared trial summary
PACEMAKER IN ANTICOAGULATED PATIENTS
Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.
Key facts
- Sponsor
- Hospital Universitario Tajo
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-01-30
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hospital Universitario Tajo
External identifiers
- EU CT number
- 2025-520929-20-00
- EudraCT number
- 2019-002118-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.
Secondary objectives 1
- Assess the occurrence of the following events: • Infectious complications • Duration of the procedure • Hospital stay • Need for blood products • Need for prohemostatic drugs • Thrombotic complications
Conditions and MedDRA coding
PACEMAKER IN ANTICOAGULATED PATIENTS
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10047075 | Vascular haemorrhagic disorders | 10047065 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- All patients undergoing permanent pacemaker implantation, over 18 years of age, who give their consent and who receive anticoagulant therapy with acenocoumarol prior to the procedure.
Exclusion criteria 1
- • Minors under 18 years of age • Use of antiplatelet agent other than ASA in the 5 days prior to implantation • INR >3.5 or INR <2 • Denial of informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Evaluation of hemorrhage and/or hematoma in patients anticoagulated with acenocoumarol after pacemaker implantation and the effect of tranexamic acid (TXA) to reduce these events.
Secondary endpoints 1
- Assess the occurrence of the following events: • Infectious complications • Duration of the procedure • Hospital stay • Need for blood products • Need for prohemostatic drugs • Thrombotic complications
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Amchafibrin 500 mg solución inyectable
PRD11559701 · Product
- Active substance
- Tranexamic Acid
- Substance synonyms
- LB1148, 4-(AMINOMETHYL)CYCLOHEXANE-1-CARBOXYLIC ACID, AMCA, TRANS-AMCHA
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B02AA02 — TRANEXAMIC ACID
- Marketing authorisation
- 53939
- MA holder
- MEDA PHARMA S.L.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario Tajo
- Sponsor organisation
- Hospital Universitario Tajo
- Address
- Avenida Amazonass/n
- City
- Aranjuez
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario Tajo
- Contact name
- Rafael Blancas-Casero
Public contact point
- Organisation
- Hospital Universitario Tajo
- Contact name
- Rafael Blancas-Casero
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 100 | 3 |
| 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 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ProtocoloATX | 1 |
| Recruitment arrangements (for publication) | CHECK LIST CONSULTA PREIMPLANTE | 1 |
| Subject information and informed consent form (for publication) | Consentimiento informado TXA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ficha tecnica | 1 |
| Synopsis of the protocol (for publication) | ProtocoloATX | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-30 | Spain | Acceptable 2025-01-30
|
2025-01-30 |