Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus

Acute Myocardial Infarction Clinical Trial

— OATH-AMI  

Official title:

A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03415386
• Other study ID #: OATH-AMI
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: February 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Liansheng Wang, Doctor
• Phone: 86 25 68303125
• Email: drlswang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A multi-center study will be done to explore the optimal regimen of antithrombotic therapy for acute myocardial infarction with left ventricular mural thrombus. The investigators will evaluate the different combinations of antiplatelet drugs and anticoagulants for at least one month, such as aspirin 100mg qd+clopidogrel 75mg qd+warfarin (INR1.8-2.2), aspirin 100mg qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin (INR1.8-2.2), and aspirin 100mg qd+ticagrelor 60mg bid+dabigatran 110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel 75mg qd/ticagrelor 60mg bid. Then the investigators will complete the 12-month follow-up to evaluate the efficacy and safety of the optimal antithrombotic therapy regimen for acute myocardial infarction with left ventricular mural thrombus.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• acute myocardial infarction with left ventricular mural thrombus

Exclusion Criteria:

• BARC bleedings = 2

• atrial fibrillation

• acute stroke or other systemic circulation embolism

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Left Ventricular Thrombus
• Myocardial Infarction
• Thrombosis

Intervention

Drug:
• Combination of antiplatelet drugs and anticoagulants for at least one month
Combination of antiplatelet drugs and anticoagulants for at least one month, such as aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.2), and aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel75mg qd/ticagrelor60mg bid.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

References & Publications (5)

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, Widimský P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. — View Citation

Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. Review. — View Citation

Reeder GS, Lengyel M, Tajik AJ, Seward JB, Smith HC, Danielson GK. Mural thrombus in left ventricular aneurysm: incidence, role of angiography, and relation between anticoagulation and embolization. Mayo Clin Proc. 1981 Feb;56(2):77-81. — View Citation

Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group . 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. — View Citation

Turpie AG, Robinson JG, Doyle DJ, Mulji AS, Mishkel GJ, Sealey BJ, Cairns JA, Skingley L, Hirsh J, Gent M. Comparison of high-dose with low-dose subcutaneous heparin to prevent left ventricular mural thrombosis in patients with acute transmural anterior myocardial infarction. N Engl J Med. 1989 Feb 9;320(6):352-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major bleeding	Bleeding Academic Research Consortium (BARC) bleedings = 2	12 months
Other	Minor bleeding	BARC bleedings < 2	12 months
Primary	Left ventricular mural thrombus-1	Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.	1-month
Primary	Left ventricular mural thrombus-3	Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.	3-month
Primary	Left ventricular mural thrombus-6	Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.	6-month
Secondary	Death		12 months
Secondary	Recurrent myocardial infarction		12 months
Secondary	Stroke or other systemic circulation embolism		12 months
Secondary	Stent restenosis		12 months
Secondary	Target vessel revascularization		12 months
Secondary	Major cardio-cerebral vascular events	Composite of any events from outcome 2 to 6	12 months