Clinical trial • Phase III • Cardiology

Tranexamic acid for Pacemaker implantation in anticoagulated patients

Phase III trial of Tranexamic acid for Pacemaker implantation in anticoagulated patients. 100 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Pacemaker implantation in anticoagulated patients
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
30-01-2025
First CTIS Authorization Date
30-01-2025

Trial design

Phase III trial across 3 sites in Spain.

Target Sample Size
100

Eligibility

Recruits 100 No vulnerable populations selected; participants must be over 18 years of age and provide informed consent..

Vulnerable Population
No vulnerable populations selected; participants must be over 18 years of age and provide informed consent.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- • Minors under 18 years of age\n- • Use of antiplatelet agent other than ASA in the 5 days prior to implantation\n- • INR >3.5 or INR <2\n- • Denial of informed consent"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"No measurement approach or detailed endpoint definition specified in the CTIS record."}

Secondary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":"No measurement approach or detailed definition specified in the CTIS record."}

Recruitment

Planned Sample Size
100
Recruitment Window Months
65
Consent Approach
Written informed consent required from each participant (participants must be over 18). A subject information and informed consent form is listed ('Consentimiento informado TXA'). No assent process for minors is applicable (minors are excluded). Languages of the consent form are not specified in the CTIS record.

Geography

Total Number Of Sites
3
Total Number Of Participants
100

Spain

Earliest CTIS Part Ii Submission Date
29-01-2025
Latest Decision Or Authorization Date
30-01-2025
Processing Time Days
1
Number Of Sites
3
Number Of Participants
100

Sites

Site Name
Hospital del Sur
Department Name
ICU
Contact Person Name
Rafael Blancas-Casero
Site Name
Hospital Universitario Tajo
Department Name
ICU
Contact Person Name
Madian Manso Alvarez
Site Name
Hospital Universitario Príncipe de Asturias
Department Name
ICU
Contact Person Name
Maria Cristina Martínez Díaz

Sponsor

Primary sponsor

Full Name
Hospital Universitario Tajo
Organisation Type
Health care
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
Amchafibrin 500 mg solución inyectable
Active Substance
Tranexamic acid
Modality
Small molecule
Routes Of Administration
Cutaneous (topical)
Route
Cutaneous use
Authorisation Status
Authorised (marketingAuthNumber 53939, country ES)
Maximum Dose
1500 mg (max total / daily amount reported in record)

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