Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rivaroxaban 15 MG [Xarelto].
- Who it may be relevant to
- Registry conditions: ST-segment Elevation Myocardial Infarction (STEMI), Left Ventricular Thrombus. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Overview
Contemporary data are lacking regarding the management of left ventricular thrombus (LVT) developed after ST segment elevation myocardial infarction
Detailed description
Left ventricular thrombus (LVT) is a commom complication after ST segment elevation myocardial infarction (STEMI), reperfusion therapy have reduced the incidence of LVT, however, about 6% of all STEMI patients will develop LVT. the risk of LVT development in anterior STEMI with reduced LVEF are as high as 20%. Although current guideline recommend anti-coagulation therapy, but the evidence still based on observational data, there has been inconsistency with the benefit of the coagulation therapy, give the significant increased bleeding risk by superimpose anti-coagulation therapy to the dual anti-platelet therapy. especially in the era of more potent anti-platelet P2Y12 inhibitor widely used clinical. the mechanism of LVT is different from that of the atrial fibrillation in which the risk of systemic embolism is persistent, coagulation bring absolute clinical benefit for high risk patients. however, for LVT developed following STEMI tend to be temporary, majority of thrombus resolve within 1-3 months after STEMI event. more likely a reflection of coagulation system in response to the necrosis of infarct myocardium. The optimal management in LVT after STEMI warrants further exploration. the desiring of randomized controlled clinical trial to compare dual anti platelet + anti-coagulation and dual anti-platelet without anti-coagulation in patient LVT are justified.
Interventions
- Drug Rivaroxaban 15 MG [Xarelto]
Eligible subjects randomized into experimental group will receive rivaroxaban 15mg daily in addition to dual anti platelet therapy unless confirmed resolution of the left ventricular thrombus.
Primary outcome measures
- Percentage of participants with the first occurrence of Stroke and other systemic embolism [Time frame: 12 months]
Secondary outcome measures (7)
- Composite major adverse events [Time frame: 12months]
- LVT resolution [Time frame: 12 months]
- Total LVT present time [Time frame: 12 months]
- Percentage of Participants With Clinically Significant Bleeding [Time frame: 12 months]
- Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding [Time frame: 12 months]
- Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding [Time frame: 12 months]
- cardiac death [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
Established ST segment elevation myocardial infarction within 7 days Left ventricular thrombus (LVT) is detected by either cardiac magnetic resonance (CMR) or TTE.
Ongoing treatment with dual anti-platelet therapy according to ESC/AHA guidelines at the time of randomization
Exclusion criteria
Clinically or hemodynamically unstable planed major surgeon such as CABG or Valve replacement within next 12 months Concomitant condition that requires anti- coagulation therapy, such as AF, DVT.
Any contraindication of anticoagulant therapy History of intracranial hemorrhage; Woman who is currently pregnant, or breastfeeding serious impaired renal and liver functions life expectancy less than 1 year can not provide consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Jilin university — Changchun
Publications
- Delewi R, Zijlstra F, Piek JJ. Left ventricular thrombus formation after acute myocardial infarction. Heart. 2012 Dec;98(23):1743-9. doi: 10.1136/heartjnl-2012-301962. No abstract available. PMID 23151669
- Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057. PMID 32273033
- Kontny F, Dale J, Hegrenaes L, Lem P, Soberg T, Morstol T. Left ventricular thrombosis and arterial embolism after thrombolysis in acute anterior myocardial infarction: predictors and effects of adjunctive antithrombotic therapy. Eur Heart J. 1993 Nov;14(11):1489-92. doi: 10.1093/eurheartj/14.11.1489. PMID 8299630
- Neskovic AN, Marinkovic J, Bojic M, Popovic AD. Predictors of left ventricular thrombus formation and disappearance after anterior wall myocardial infarction. Eur Heart J. 1998 Jun;19(6):908-16. doi: 10.1053/euhj.1998.0871. PMID 9651715
- Nadareishvili ZG, Choudary Z, Joyner C, Brodie D, Norris JW. Cerebral microembolism in acute myocardial infarction. Stroke. 1999 Dec;30(12):2679-82. doi: 10.1161/01.str.30.12.2679. PMID 10582996
Identifiers
NCT: NCT05892042 · ACT on LVT