Prevention of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant (EARLYmyo-LVT Ⅱ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03786757|
Recruitment Status : Not yet recruiting
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|ST Segment Elevation Myocardial Infarction Left Ventricular Thrombus||Drug: Rivaroxaban||Phase 3|
According to the newest JAMA review, the incidence of left ventricular thrombus (LVT) in the ST-segment elevation myocardial infarction (STEMI) infarction patients is 15%, with particularly 25% in the anterior STEMI patients. Therefore, it is very necessary to find to strategy to prevent to the left ventricular thrombus formation in STEMI patients.
In the 2013 AHA STEMI guidelines and 2014 AHA stroke prevention guidelines, it was advised to add warfarin to traditional double anti-platelet therapy in anterior STEMI with INR between 2.0 to 2.5. However, date from 2015 to 2017 have suggested potentially less demonstrable benefits with warfarin in the prevention of LV thrombus. In an observational study of 460 patients with anterior STEMI and apical akinesis or dyskinesis who underwent PCI, Le May et al 30 compared outcomes in patients who did and did not receive warfarin. Compared with patients in the no warfarin group, patients treated with warfarin had higher rates of composite all-cause mortality, stroke, re-infarction, and major bleeding within 180 days (15% vs 5%), death (5% vs 2%), stroke (3% vs 0.3%), and major bleeding(9% vs 2%). There were no differences in LV thrombus formation between groups. Another observational study undertaken by Shavadia et al reached a similar conclusion that prophylactic warfarin use was not associated with lower composite end point of recurrent ischemia, stroke/transient ischemic attack/systemic embolism, or all-cause death but was associated with higher major bleeding rates at 1 year (2.5% vs 1.2%). The secondary analysis of the Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial found the same results.
On the other hand, addition of Rivaroxaban to double anti-platelet therapy is very likely to be proved beneficial in STEMI patients. In the Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome 2-Thrombolysis in Myocardial Infarction 51 (ATLAS ACS 2-TIMI 51) trial, the researchers found that the addition of reduced doses of rivaroxaban to double anti-platelet therapy after STEMI reduced a composite of cardiovascular death, MI, or stroke from 10.6% to 8.4% (P = .02) but increased major bleeding (2.2% vs 0.6%; P < .001) and intracranial hemorrhage (0.6% vs 0.1%; P = .02). However, the 2.5-mg twice-daily dose of rivaroxaban when added largely to a background of aspirin and clopidogrel significantly reduced the rate of all-cause mortality vs placebo. What's more, in 2017 the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial demonstrated that rivaroxaban (2.5mg twice daily) reduced the risk of ischemic events compared with placebo on a back ground of low-dose aspirin in abroad population of patients with stable coronary or peripheral artery disease. Therefore, using low dose rivaroxaban (2.5mg twice daily) to prevent post-STEMI LVT is rather promising.
This study aims to evaluate the therapeutic efficacy and safety of rivaroxaban on the prevention of post-STEMI LVT.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Anticoagulant on Early Prevention of Post-STEMI Left Ventricular Thrombus: an Open, Prospective, Randomized and Multi-centers Trial.|
|Estimated Study Start Date :||April 1, 2019|
|Estimated Primary Completion Date :||March 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
rivaroxaban will be added in addition to dual antiplatelet therapy.
Rivaroxaban 2.5mg/BID will be applied for 24 weeks unless severe safety outcome occurs. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.
Other Name: Xarelto®
No Intervention: dual antiplatelet therapy (DAPT)
Conventional dual antiplatelet therapy will be adopted.
- The accumulative percentage of LVT formation at 24 weeks [ Time Frame: at 24 weeks ]The LVT resolve will be determined monthly by follow-up imaging examination (CMR or TTE). The percentage of LVT resolve at 24 weeks will be calculated for each group.
- Bleeding events (ISTH criteria) through the study, an average of 24 weeks [ Time Frame: through the study completion, an average of 24 weeks. ]Bleeding events will be classified by the ISTH criteria. Major bleeding is defined using ISTH criteria as clinically over bleeding that is associated with: 1. A fall in hemoglobin of 2g/dL or more or 2.A transfusion of 2 or more units of packed red blood cells or whole blood, or 3.A critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retropertioneal, or 4. A fatal outcome. All bleeding events will be documented through the study, an average of 24 weeks.
- Composite major adverse events through the study, an average of 24 weeks [ Time Frame: through the study completion, an average of 24 weeks. ]The incidence of a composite adverse events, including all-cause death, recurrent myocardial infarction, ischemic stroke and other systemic embolism through 24 weeks will be calculated for each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786757
|Contact: Jun Pu, Professoremail@example.com|
|Contact: Qin Shao, Professorfirstname.lastname@example.org|
|Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University||Not yet recruiting|
|Shanghai, Shanghai, China, 200127|
|Contact: Jun Pu, Professor 86-21-68383477 email@example.com|