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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
EU CTIS ID: 2022-500383-35-00
What this study is testing
To estimate the proportion of patients experiencing thrombus resolution and/or symptomatic or asymptomatic brain infarction after 3 months of anticoagulant treatment with dabigatran or phenoprocoumon in patients with left ventricular thrombus after STEMI (ST-elevation myocardial infarction).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.