Vitamin-K-Antagonist and direct thrombin inhibitor Dabigatran for thrombus resolution in left ventricular thrombus after acute STEMI (ST-elevation myocardial infarction): an open label randomized controlled multicenter Phase-II study

Phase 1

Recruiting

• Conditions: STEMI (ST elevation myocardial infarction), Left ventricular thrombosis; MedDRA version: 20.1Level: LLTClassification code: 10080067Term: Left ventricular thrombosis Class: 10007541; MedDRA version: 20.0Level: LLTClassification code: 10064346Term: STEMI Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2022-500383-35-00
• Lead Sponsor: Medical University Of Graz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

Patients diagnosed with STEMI undergoing PCI (percutaeous coronary intervention) and having the LAD (left anterior descending artery) as the culprit vessel, Clinical risk score for LV-Thrombus >2 points, Age 18 years or older, Informed consent has to be given in written form, eGFR > 30 ml/min/1.73m2

Exclusion Criteria

Any other form of myocardial infarction (NSTEMI) than STEMI, Known intracardiac thrombus (including cardiac ear thrombi), Cirrhosis of the liver (Child A-C), Any contraindication to study drugs or auxiliary drugs, Any contraindication for an cardiac MRI (e.g. metal implants or non-certified pacemaker systems), Persons unable to give consent or cannot understand the purpose of the study (dementia, etc.), or should be excluded by investigator's decision, Persons who cannot take the study measures / tablets or have a questionable compliance, Persons with limited life expectancy (< 3 months), Active bleeding or any prior bleeding episode in the last seven days other than intracranial bleeding, Intracranial bleeding in the last 6 months, Known allergy to thrombin inhibitor dabigatran, Haemodynamic instability as defined by intravenous administration of catecholamine, calciumsensitizers or phosphodiesterase inhibitors, Pregnancy or Breastfeeding, Preexisting oral anticoagulant therapy (VKA or NOAC), eGFR < 30ml/min/1.73m2, Parallel, ongoing participation in another pharmacological trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified