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ST Segment Elevation Myocardial InfarctionPhase 3EARLYmyo-LVTNCT03764241

Treatment of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant

A Phase 3 study testing Rivaroxaban and Vitamin K Antagonist in people with ST Segment Elevation Myocardial Infarction and Left Ventricular Thrombus, run by RenJi Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Left ventricular thrombus is a common complication subsequent to ST-segment elevation myocardial infarction (STEMI) that related to increased embolic events. This study aims to assess the efficacy and safety outcomes of Rivaroxaban on the treatment of post-STEMI left ventricular thrombus. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Rivaroxaban and Vitamin K Antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
1 Feb 2020to 30 Dec 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age:18-75 years old.
  • Myocardial infarction diagnosed by 1) typical ischemic symptom, 2) elevated ST segment at the J-point in two contiguous leads (ST elevation should be ≥2mm in men ≥40years; ≥2.5mm in men <40years, or ≥1.5mm in women regardless of age in leads V2 and V3; and ≥1mm in leads other than V2 and V3 ); 3) elevated cardiac troponin value with at least one value above 99th percentile upper reference limit（UPL); 4) confirmed by coronary angiography (CAG) or imaging evidence of new loss of anterior myocardium.
  • Left ventricular thrombus (LVT) is detected by either cardiac magnetic resonance (CMR) or TTE in 45 days after symptom onset.

Who cannot join

  • Any contraindication of anticoagulant therapy or unacceptable risk of bleeding
  • Active bleeding;
  • History of intracranial hemorrhage;
  • Clinically significant gastrointestinal bleeding within 12 months before randomization;
  • Severe thrombocytopenia (<50x109/L), or Anemia (i.e. Hemoglobin <90g/L) at screening or pre-randomization;
  • Liver function Child-Pugh B or C
Show all 23Show fewer
  • Untreated arterial aneurysm, arterial or venous malformation and aorta dissection;
  • Body weight <40kg
  • Undergoing anticoagulant therapy before STEMI onset
  • Cardiovascular condition
  • Cardiac shock
  • Uncontrolled blood pressure (SBP\geq180mmHg);
  • Planned CABG within 3months
  • Suspicious Pseudo-ventricular aneurysm
  • Concomitant diseases
  • Severe chronic or acute renal failure (CrCl<50ml/min at screening or pre-randomization)
  • Significantly liver disease
  • Current substance abuse (drug or alcohol) problem
  • Life expectancy to less than 12 months
  • Known allergies, or intolerance to rivaroxaban
  • Woman who is currently pregnant, or breastfeeding
  • Other hypercoagulable state, such as malignat tumor, SLE
  • Other conditions adjudicated by investigators to be unsuitable to anticoagulation

Trial locations and contacts

1 site in 1 country.

Jun Pu, Professor contact

08602168383164

pujun310@hotmail.com

Heng Ge, M.D. contact

08602168383164

dr.geheng@foxmail.com

China1 site, 1 recruiting

  • Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

    Shanghai, Shanghai Municipality, 200127

    Jun Pu, Professor, 86-21-68383477, pujun310@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Anticoagulant on Early Treatment of Post-STEMI Left Ventricular Thrombus: an Open, Prospective, Randomized and Multi-centers Trial.

Left ventricular thrombus is a common complication subsequent to ST-segment elevation myocardial infarction (STEMI) that related to increased embolic events. This study aims to assess the efficacy and safety outcomes of Rivaroxaban on the treatment of post-STEMI left ventricular thrombus.

Read the detailed description

Despite the fast development and popularization of reperfusion as well as adjunctive medical therapy, complications of STEMI remain critical causes of adverse events. Among them, the formation of the left ventricular thrombus (LVT) subsequent to STEMI is not rare. The incidence of STEMI-related LVT could be as higher as 31%-56% in the earlier time when thrombolysis was the mainstream of reperfusion . The risk lowers in the ear of the primary PCI, but LVT can still be detected in around 15% patients. Anterior MI is the most critical determinant of LVT. In a study including 2911 patients, 93.2% LVT occurred due to the occlusion of left artery descending (LAD). More than 2/3 of LVT was reported within the first two weeks of STEMI, late thrombus can be found in three months or even later. The existence of LVT is clearly related to increased risk of embolic events and death. In a meta-analysis in 2019, STEMI patients with LVT demonstrated a 3.97 times higher risk of embolic events than those without LVT. In a recent study, the rate of 5-year embolism in STEMI patients with LVT was up to 16.9% if without effective therapy, significantly higher than the rate of 2.9% in patients without LVT and 3% in patients with LVT but undergoing ideal therapy.

Current therapeutic guidelines recommend anticoagulant therapy for post-STEMI LVT. Since most of the LVT would be found in the acute phase of STEMI, the anticoagulant therapy is usually in addition to antiplatelet treatment. So far, Vitamin K antagonist (VKA) is still the standard medication in the treatment of LVT. The 2013 ACC/AHA guideline for STEMI management recommended adding VKA to the dual-antiplatelet regiment in patients with LVT for at least 3 months. Similarly, the 2014 ASA guideline for primary prevention of stroke gave an IIa level recommendation to use VKA adjunctive to antiplatelet medications in STEMI patients developing LVT. The treatment of VKA seems effective to both resolve LVT and decrease embolic events. In two small studies, the triple antithrombotic regimen comprising of VKA and dual antiplatelet (aspirin and clopidogrel) for 3 months resolved 88% and 92.3% LVT on echo, respectively. The addition of VKA remarkably could reduce the embolic events to 0-3% as reported in different studies.

However, the complicated titrations and the need to frequently monitor international normalized ratios (INRs) make the use of warfarin inconvenient, especially for patients who have difficulty to access medical services regularly. Therefore, the use of novel oral anticoagulants (NOACs) as a substitute for warfarin is highly attractive. However, the efficacy of NOACs in the treatment of STEMI-related LVT is not clear. Current experiences come from small series of case reports. Rivaroxaban is a potent Xa factor inhibitor. In the field of cardiology, it has become a preferred replacement of VKA in the prevention of embolic events due to the left atrial thrombus. In the X-TRA study, 15mg/QD rivaroxaban resolved 41% of left atrial thrombus. In the case of post-STEMI LVT, 15mg/QD rivaroxaban additional to dual antiplatelet therapy resolved all 4 cases of LVT in 2-4 weeks in a Cyprus study. In an American case series, 20mg /QD rivaroxaban plus one antiplatelet medication (clopidogrel) also successfully resolved LVT in 2 patients. Therefore, using NOACs to treat post-STEMI LVT is promising. The 2017 ESC guideline for STEMI management doesn't limit the choice of anticoagulation for LVT only to VKA, but the application of NOACs still needs further confirmation.

This study aims to evaluate the therapeutic efficacy and safety of rivaroxaban on the treatment of post-STEMI LVT.

Being tested
Rivaroxaban, Vitamin K Antagonist
Keywords
STEMI, left ventricular thrombus, rivaroxaban
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

    Rivaroxaban 15mg/QD will be applied for 3 months 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.

  • Vitamin K AntagonistDrug

    warfarin (INR 2.0-2.5) will be applied for 3 months unless severe safety outcome occur. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.

Study groups in NCT03764241
Study groupRoleWhat they receive
RivaroxabanExperimentalrivaroxaban will be added in addition to dual antiplatelet therapy
Receives: Drug: Rivaroxaban
Vitamin K AntagonistActive comparatorwarfarin will be added in addition to dual antiplatelet therapy
Receives: Drug: Vitamin K Antagonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of LVT resolution after triple antithrombotic therapy for 3 month

    The LVT resolve will be determined monthly by follow-up imaging examination (CMR or TTE). The percentage of LVT resolve at 3 months will be calculated for each group.

    Measured: 3 months

  2. Major bleeding events (ISTH criteria) through the study, an average of 12 weeks

    Major Bleeding events will be classified by the ISTH criteria.It is defined 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 12weeks

    Measured: Through the study, an average of 12 weeks

Secondary outcomes (4)

  1. Composite major adverse events through the study, an average of 3 months and 1 year

    The incidence of a composite adverse events, including all-cause death, recurrent myocardial infarction, ischemic stroke and other systemic embolism through 3 months and 1 year will be calculated for each group.

    Measured: Through study completion, an average of 3 months and 1 year

  2. Non-major bleeding events (ISTH criteria) through the study, an average of 3 months and 1 year

    Non-major bleeding events is identified by ISTH ctiteria.

    Measured: Through study completion, an average of 3 months and 1 year

  3. Time to LVT resolution

    The time from LVT detected to LVT resolution

    Measured: from LVT detected to LVT resolution

  4. Incidence of any systemic embolic events within 3 months and 1 year

    Incidence of any systemic embolic events within 3 months and 1 year after triple therapy.

    Measured: within 3 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start1 Feb 2020
  3. Primary completion30 Mar 2022
  4. Study completion30 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764241
Sponsor's protocol ID
Cardiology-LVT
Acronym
EARLYmyo-LVT
Status last verified
Dec 2022
First submitted
24 Nov 2018
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Keren A, Goldberg S, Gottlieb S, Klein J, Schuger C, Medina A, Tzivoni D, Stern S. Natural history of left ventricular thrombi: their appearance and resolution in the posthospitalization period of acute myocardial infarction. J Am Coll Cardiol. 1990 Mar 15;15(4):790-800. doi: 10.1016/0735-1097(90)90275-t.

    PubMed 2307788

  • Mooe T, Teien D, Karp K, Eriksson P. Left ventricular thrombosis after anterior myocardial infarction with and without thrombolytic treatment. J Intern Med. 1995 Jun;237(6):563-9. doi: 10.1111/j.1365-2796.1995.tb00886.x.

    PubMed 7782728

  • Domenicucci S, Chiarella F, Bellotti P, Lupi G, Scarsi G, Vecchio C. Early appearance of left ventricular thrombi after anterior myocardial infarction: a marker of higher in-hospital mortality in patients not treated with antithrombotic drugs. Eur Heart J. 1990 Jan;11(1):51-8. doi: 10.1093/oxfordjournals.eurheartj.a059592.

    PubMed 2307163

  • Solheim S, Seljeflot I, Lunde K, Bjornerheim R, Aakhus S, Forfang K, Arnesen H. Frequency of left ventricular thrombus in patients with anterior wall acute myocardial infarction treated with percutaneous coronary intervention and dual antiplatelet therapy. Am J Cardiol. 2010 Nov 1;106(9):1197-200. doi: 10.1016/j.amjcard.2010.06.043. Epub 2010 Sep 9.

    PubMed 21029812

  • Zielinska M, Kaczmarek K, Tylkowski M. Predictors of left ventricular thrombus formation in acute myocardial infarction treated with successful primary angioplasty with stenting. Am J Med Sci. 2008 Mar;335(3):171-6. doi: 10.1097/MAJ.0b013e318142be20.

    PubMed 18344689

  • Vaitkus PT, Barnathan ES. Embolic potential, prevention and management of mural thrombus complicating anterior myocardial infarction: a meta-analysis. J Am Coll Cardiol. 1993 Oct;22(4):1004-9. doi: 10.1016/0735-1097(93)90409-t.

    PubMed 8409034

  • Maniwa N, Fujino M, Nakai M, Nishimura K, Miyamoto Y, Kataoka Y, Asaumi Y, Tahara Y, Nakanishi M, Anzai T, Kusano K, Akasaka T, Goto Y, Noguchi T, Yasuda S. Anticoagulation combined with antiplatelet therapy in patients with left ventricular thrombus after first acute myocardial infarction. Eur Heart J. 2018 Jan 14;39(3):201-208. doi: 10.1093/eurheartj/ehx551.

    PubMed 29029233

  • Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Rev Esp Cardiol (Engl Ed). 2017 Dec;70(12):1082. doi: 10.1016/j.rec.2017.11.010. No abstract available. English, Spanish.

    PubMed 29198432

  • Meschia JF, Bushnell C, Boden-Albala B, Braun LT, Bravata DM, Chaturvedi S, Creager MA, Eckel RH, Elkind MS, Fornage M, Goldstein LB, Greenberg SM, Horvath SE, Iadecola C, Jauch EC, Moore WS, Wilson JA; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; Council on Functional Genomics and Translational Biology; Council on Hypertension. Guidelines for the primary prevention of stroke: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014 Dec;45(12):3754-832. doi: 10.1161/STR.0000000000000046. Epub 2014 Oct 28.

    PubMed 25355838

  • O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.

    PubMed 23256914

  • Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

    PubMed 30165437

  • Delewi R, Nijveldt R, Hirsch A, Marcu CB, Robbers L, Hassell ME, de Bruin RH, Vleugels J, van der Laan AM, Bouma BJ, Tio RA, Tijssen JG, van Rossum AC, Zijlstra F, Piek JJ. Left ventricular thrombus formation after acute myocardial infarction as assessed by cardiovascular magnetic resonance imaging. Eur J Radiol. 2012 Dec;81(12):3900-4. doi: 10.1016/j.ejrad.2012.06.029. Epub 2012 Sep 17.

    PubMed 22995173

  • Makrides CA. Resolution of left ventricular postinfarction thrombi in patients undergoing percutaneous coronary intervention using rivaroxaban in addition to dual antiplatelet therapy. BMJ Case Rep. 2016 Oct 26;2016:bcr2016217843. doi: 10.1136/bcr-2016-217843.

    PubMed 27797850

  • Smetana KS, Dunne J, Parrott K, Davis GA, Collier ACS, Covell M, Smyth S. Oral factor Xa inhibitors for the treatment of left ventricular thrombus: a case series. J Thromb Thrombolysis. 2017 Nov;44(4):519-524. doi: 10.1007/s11239-017-1560-7.

    PubMed 28948507

  • Nagamoto Y, Shiomi T, Matsuura T, Okahara A, Takegami K, Mine D, Shirahama T, Koga Y, Yoshida K, Sadamatsu K, Hayashida K. Resolution of a left ventricular thrombus by the thrombolytic action of dabigatran. Heart Vessels. 2014 Jul;29(4):560-2. doi: 10.1007/s00380-013-0403-5. Epub 2013 Sep 5.

    PubMed 24005764

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban and Vitamin K Antagonist in people with ST Segment Elevation Myocardial Infarction and Left Ventricular Thrombus, run by RenJi Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jun Pu, Professor (08602168383164, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of LVT resolution after triple antithrombotic therapy for 3 month (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764241, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.

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