AzTrials
AzTrials

Acute Myocardial InfarctionPhase 4OATH-AMINCT03415386

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

A Phase 4 study testing Combination of antiplatelet drugs and anticoagulants for at least one month in people with Acute Myocardial Infarction and Left Ventricular Thrombus, run by The First Affiliated Hospital with Nanjing Medical University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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… Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Combination of antiplatelet drugs and anticoagulants for at least one month
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
No sites listed yet
Study dates
Jun 2020to Jun 2022
Phase
Phase 4
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute myocardial infarction with left ventricular mural thrombus

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Liansheng Wang, Doctor contact

86 25 68303125

drlswang@njmu.edu.cn

Haoyu Meng, Doctor contact

86 25 68303126

haoyu_meng@163.com

About this study

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

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.

Being tested
Combination of antiplatelet drugs and anticoagulants for at least one month

What participants receive

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

  • Combination of antiplatelet drugs and anticoagulants for at least one monthDrug

    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.

Study groups in NCT03415386
Study groupRoleWhat they receive
aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2)ExperimentalNot described
Receives: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bidExperimentalNot described
Receives: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
aspirin100mg qd+ticagrelor60mg bid+warfarin(INR1.8-2.2)ExperimentalNot described
Receives: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month
aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bidExperimentalNot described
Receives: Drug: Combination of antiplatelet drugs and anticoagulants for at least one month

What is being measured

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

  1. Left ventricular mural thrombus-1

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

    Measured: 1-month

  2. Left ventricular mural thrombus-3

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

    Measured: 3-month

  3. Left ventricular mural thrombus-6

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

    Measured: 6-month

Secondary outcomes (6)

  1. Death

    Measured: 12 months

  2. Recurrent myocardial infarction

    Measured: 12 months

  3. Stroke or other systemic circulation embolism

    Measured: 12 months

  4. Stent restenosis

    Measured: 12 months

  5. Target vessel revascularization

    Measured: 12 months

  6. Major cardio-cerebral vascular events

    Composite of any events from outcome 2 to 6

    Measured: 12 months

Timeline

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

  1. First posted30 Jan 2018
  2. Study startJun 2020 (estimated)
  3. Primary completionDec 2020 (estimated)
  4. Study completionJun 2022 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03415386
Sponsor's protocol ID
OATH-AMI
Acronym
OATH-AMI
Status last verified
Feb 2020
First submitted
11 Jan 2018
Last updated
11 Feb 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 26320110

  • 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.

    PubMed 28886621

  • 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.

    PubMed 7464234

  • 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.

    PubMed 2643772

  • 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.

    PubMed 8821415

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combination of antiplatelet drugs and anticoagulants for at least one month in people with Acute Myocardial Infarction and Left Ventricular Thrombus, run by The First Affiliated Hospital with Nanjing Medical University.

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 1 inclusion and 3 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Liansheng Wang, Doctor (86 25 68303125, drlswang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left ventricular mural thrombus-1 (time frame: 1-month). The study lists 3 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 NCT03415386, which also lists 5 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 11 Feb 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in