Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJilin University

About this trial

Contemporary data are lacking regarding the management of left ventricular thrombus (LVT) developed after ST segment elevation myocardial infarction

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rivaroxaban 15 MG [Xarelto]

    Drug

    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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Percentage of participants with the first occurrence of Stroke and other systemic embolism

The percentage of participants with the first occurrence of Stroke and other systemic embolism were evaluated.

Time frame
12 months

Secondary outcomes

1

Composite major adverse events

The incidence of a composite adverse events, including all cause mortality, recurrent myocardial infarction, ischemic stroke and other systemic embolism

Time frame
12months
2

LVT resolution

the LVT resolve will be determined monthly by follow-up imaging examination (Echo cardiograph or Cardiac magnetic resonance). The percentage of LVT resolve at 3 months will be calculated for each group.

Time frame
12 months
3

Total LVT present time

LVT will be followed every month in the first 3 months, every 3 months thereafter to determine the present of LVT by Echo cardiograph or Cardiac magnetic resonance.

Time frame
12 months
4

Percentage of Participants With Clinically Significant Bleeding

Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (\>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of \>=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (\<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to \<15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.

Time frame
12 months

Other outcomes

Sponsors and contacts

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