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

NCT03415386 | Unknown Phase 4

• 1 other identifier: OATH-AMI
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Myocardial Infarction; Left Ventricular Thrombus

Outcome Measures

Primary Outcomes (3)

• Left ventricular mural thrombus-1

  Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 1-month.

  1-month

• Left ventricular mural thrombus-3

  Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 3-month.

  3-month

• Left ventricular mural thrombus-6

  Number of Participants Without left ventricular mural thrombus as Assessed by echocardiograph at 6-month.

  6-month

Secondary Outcomes (6)

• Death

  12 months

• Recurrent myocardial infarction

  12 months

• Stroke or other systemic circulation embolism

  12 months

• Stent restenosis

  12 months

• Target vessel revascularization

  12 months

Other Outcomes (2)

• Major bleeding

  12 months

• Minor bleeding

  12 months

Study Arms (4)

aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)

EXPERIMENTAL

Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid

EXPERIMENTAL

Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)

EXPERIMENTAL

Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid

EXPERIMENTAL

Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

Interventions

Combination of antiplatelet drugs and anticoagulants for at least one month DRUG

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.

aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid; aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2); aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid; aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute myocardial infarction with left ventricular mural thrombus

You may not qualify if:

• BARC bleedings ≥ 2
• atrial fibrillation
• acute stroke or other systemic circulation embolism

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (5)

• 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. No abstract available.

  PMID: 26320110 BACKGROUND

• 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; 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. No abstract available.

  PMID: 28886621 BACKGROUND

• 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.

  PMID: 7464234 BACKGROUND

• 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. doi: 10.1056/NEJM198902093200604.

  PMID: 2643772 BACKGROUND

• Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. doi: 10.1002/clc.4960190203.

  PMID: 8821415 BACKGROUND

MeSH Terms

Interventions

Anticoagulants

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Liansheng Wang, Doctor

CONTACT

86 25 68303125; drlswang@njmu.edu.cn

Haoyu Meng, Doctor

CONTACT

86 25 68303126; haoyu_meng@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 30, 2018
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2022
• Last Updated: February 11, 2020

Record last verified: 2020-02