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RandomizEd compariSOn of apixaban versus warfarin in patients with Left VEntricular thrombus after Acute Myocardial Infarction (RESOLVE-AMI).
EU CTIS ID: 2024-514416-28-00
What this study is testing
The primary objective of this study is to compare the effect of apixaban versus warfarin with respect to thrombus resolution in patients with left ventricular thrombus after acute myocardial infarction (AMI).
- Therapeutic use (Phase IV)
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
- Participants must be ≥ 18 years at the time of signing the informed consent.
- Left ventricular thrombus confirmed on transthoracic echocardiogram (TTE) or when inconclusive documented on cardiac magnet resonance imaging (MRI) or computed tomography (CT) on day 1-28 after the acute myocardial infarction.
- The subject has given their written consent to participate in the trial which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and study protocol.
- Criteria applicable only for female subjects: A) Women of childbearing potential must provide a negative pregnancy test at inclusion, not be breastfeeding and be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of study drug; B) Women of non-childbearing potential must be 1 year post-menopausal.
You likely can't join if
- Ongoing treatment with anticoagulant therapy due to: A) Mechanical heart valve prosthesis (not including transcatheter aortic valve replacement); B) Atrial fibrillation with or without significant mitral valve stenosis; C) Venous thromboembolism requiring anticoagulant therapy; D) Thrombophilia requiring anticoagulant therapy; E) Preexisting left ventricular thrombus already on anticoagulant therapy; F) Other reasons for anticoagulant therapy.
- High bleeding risk: A) Active non-trivial bleeding; B) Known chronic bleeding disorder; C) Severe anemia defined as hemoglobin < 80g/L; D) Thrombocytopenia defined as thrombocytes <80 x 10^9.
- Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as Child-Pugh C or D at randomization.
- Known allergy, intolerance or hypersensitivity to either of the study interventions (active substance or excipients).
- Any contraindication for the use of an anticoagulant or listed in the local labelling for Apixaban or warfarin.
- Participation in other study investigating effects and safety of anticoagulant treatment.
See the full eligibility criteria
Who can join
- Participants must be ≥ 18 years at the time of signing the informed consent.
- Left ventricular thrombus confirmed on transthoracic echocardiogram (TTE) or when inconclusive documented on cardiac magnet resonance imaging (MRI) or computed tomography (CT) on day 1-28 after the acute myocardial infarction.
- The subject has given their written consent to participate in the trial which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and study protocol.
- Criteria applicable only for female subjects: A) Women of childbearing potential must provide a negative pregnancy test at inclusion, not be breastfeeding and be willing and able to use highly effective contraception during the treatment and up to 3 months after the last dose of study drug; B) Women of non-childbearing potential must be 1 year post-menopausal.
What rules you out
- Ongoing treatment with anticoagulant therapy due to: A) Mechanical heart valve prosthesis (not including transcatheter aortic valve replacement); B) Atrial fibrillation with or without significant mitral valve stenosis; C) Venous thromboembolism requiring anticoagulant therapy; D) Thrombophilia requiring anticoagulant therapy; E) Preexisting left ventricular thrombus already on anticoagulant therapy; F) Other reasons for anticoagulant therapy.
- High bleeding risk: A) Active non-trivial bleeding; B) Known chronic bleeding disorder; C) Severe anemia defined as hemoglobin < 80g/L; D) Thrombocytopenia defined as thrombocytes <80 x 10^9.
- Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis) or known hepatic insufficiency classified as Child-Pugh C or D at randomization.
- Known allergy, intolerance or hypersensitivity to either of the study interventions (active substance or excipients).
- Any contraindication for the use of an anticoagulant or listed in the local labelling for Apixaban or warfarin.
- Participation in other study investigating effects and safety of anticoagulant treatment.
- Known current alcohol or drug abuse that may interfere with participants safety and or compliance as judged at the discretion of the investigator.
- Any other condition, as judged by the investigator, that would make the participant unsafe or unsuitable for the study (anticipated non-compliance or vulnerability) or very short life expectancy < 6 months.
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, 65+ years, 18-64 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.