RandomizEd compariSOn of Apixaban Versus Warfarin in Patients With Left VEntricular Thrombus After Acute Myocardial Infarction (RESOLVE-AMI)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The optimal anticoagulant for the treatment of left ventricular (LV) thrombus following acute myocardial infarction (AMI) is unclear. The aim of this multicenter randomized study is to evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution in patients with LV thrombus after AMI.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years at the time of signing the informed consent
• LV thrombus confirmed on TTE\* day 1-28 after the AMI
• Signed informed consent
• Criteria applicable only for female subjects: Women of childbearing potential must provide a negative pregnancy test not be breastfeeding and be willing and able to use highly effective contraception. Women of non-childbearing potential must be 1 year post-menopausal.
Locations
Other Locations
Sweden
Falu lasarett
NOT_YET_RECRUITING
Falun
Sahlgrenska University hospital
NOT_YET_RECRUITING
Gothenburg
Sahlgrenska University hospital, Mölndal
NOT_YET_RECRUITING
Gothenburg
Sahlgrenska University hospital, Östra
NOT_YET_RECRUITING
Gothenburg
Linköping University hospital
NOT_YET_RECRUITING
Linköping
Skånes Universitetssjukhus Lund
RECRUITING
Lund
Skånes University hospital, Malmö
NOT_YET_RECRUITING
Malmo
Vrinnevi hospital
NOT_YET_RECRUITING
Nörrköping
Örebro University hospital
NOT_YET_RECRUITING
Örebro
Danderyds hospital
NOT_YET_RECRUITING
Stockholm
Karolinska Insitutet
RECRUITING
Stockholm
Karolinska Univerity Hospital
RECRUITING
Stockholm
Sankt Görans Hospital
NOT_YET_RECRUITING
Stockholm
Södersjukhuset
NOT_YET_RECRUITING
Stockholm
Uppsala Akademiska hospital
NOT_YET_RECRUITING
Uppsala
Västmanlands hospital, Västerås
NOT_YET_RECRUITING
Västerås
Contact Information
Primary
Eva Olofsson
moa.simonsson@ki.se
+46707780897
Backup
Stina Smetana
stina.smetana@ki.se
+46725841182
Time Frame
Start Date: 2025-04-08
Estimated Completion Date: 2028-07-01
Participants
Target number of participants: 212
Treatments
Experimental: Apixaban
Apixaban 5 mg twice a day, reduced to 2.5 mg twice a day for participants with any 2 of following criteria: age \> 80 years, serum creatinine \> 133 μmol/L or body weight \<60 kg. Participants with severe renal failure defined as creatinine clearance 15-29 ml/min/1.73 m2, should also receive the reduced dose of 2.5 mg twice a day.
Active_comparator: Warfarin
Warfarin 2,5 mg once daily with individual dosing according to coagulation assays with an international normalized ratio (INR) goal of 2.0-3.0. Bridging with low-molecular-weight-heparin with a dose of dalteparin 200 units/kg but maximum 18 000 units or enoxaparin 150 units/kg, until therapeutic INR is recommended.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet
Collaborators: Karolinska Trial Alliance, Swedish Heart Lung Foundation, Stockholm County Council ALF/PPG, The Swedish Research Council