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Trial record 10 of 530 for:    Recruiting, Not yet recruiting, Available Studies | "Platelet Aggregation Inhibitors"

Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus (OATH-AMI)

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ClinicalTrials.gov Identifier: NCT03415386
Recruitment Status : Not yet recruiting
First Posted : January 30, 2018
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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 (INR1.8-2.5), aspirin 100mg qd+clopidogrel 75mg qd+dabigatran 110mg bid, aspirin 100mg qd+ticagrelor 60mg bid+warfarin (INR1.8-2.5), 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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Left Ventricular Thrombus Drug: Combination of antiplatelet drugs and anticoagulants for at least one month Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center Study on the Optimized Antithrombotic Therapy of Acute Myocardial Infarction With Left Ventricular Mural Thrombus.
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.5) 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 (INR1.8-2.5), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.5), 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.

Experimental: aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid 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 (INR1.8-2.5), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.5), 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.

Experimental: aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.5) 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 (INR1.8-2.5), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.5), 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.

Experimental: aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid 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 (INR1.8-2.5), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.5), 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.




Primary Outcome Measures :
  1. Left ventricular mural thrombus [ Time Frame: 1-month ]
    Whether the left ventricular mural thrombus dissolves

  2. Left ventricular mural thrombus-remain or recurrent [ Time Frame: 3-month ]
    Whether the mural thrombus remain or recurrent in left ventricular

  3. Left ventricular mural thrombus-still remain or recurrent [ Time Frame: 6-month ]
    Whether the mural thrombus still remain or recurrent in left ventricular


Secondary Outcome Measures :
  1. Death [ Time Frame: 12 months ]
  2. Recurrent myocardial infarction [ Time Frame: 12 months ]
  3. Stroke or other systemic circulation embolism [ Time Frame: 12 months ]
  4. Stent restenosis [ Time Frame: 12 months ]
  5. Target vessel revascularization [ Time Frame: 12 months ]
  6. Major cardio-cerebral vascular events [ Time Frame: 12 months ]
    Composite of any events from outcome 2 to 6


Other Outcome Measures:
  1. Major bleeding [ Time Frame: 12 months ]
    Bleeding Academic Research Consortium (BARC) bleedings ≥ 2

  2. Minor bleeding [ Time Frame: 12 months ]
    BARC bleedings < 2



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute myocardial infarction with left ventricular mural thrombus

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT03415386


Contacts
Contact: Liansheng Wang, Doctor 86 25 68303125 drlswang@njmu.edu.cn
Contact: Haoyu Meng, Doctor 86 25 68303126 haoyu_meng@163.com

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

Publications:

Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03415386     History of Changes
Other Study ID Numbers: OATH-AMI
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Aspirin
Ticlopidine
Clopidogrel
Adenosine
Dabigatran
Ticagrelor
Warfarin
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents