Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction
NCT ID: NCT06742567
Last Updated: 2024-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
472 participants
INTERVENTIONAL
2024-12-02
2025-11-30
Brief Summary
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Detailed Description
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Methods:
Inclusion Criteria .Patients aged 18-65 years, presenting with acute anterior STEMI and severe LV dysfunction (EF\<35%) with antero-apical akinesis, dyskinesis, or aneurysm.
Exclusion Criteria
* Patients with previous myocardial infarction or revascularization procedures.
* Patients with cardiogenic shock
* Patients with advanced CKD (Cr \< 2 and those on hemodialysis)
* Recent ICH or major bleed requiring transfusion, low platelet counts\<100,000
* History of CVA
* Patients with atrial fibrillation or other indications for chronic anticoagulation
* Pregnant patients and those with hematological disorders
Eligible patients will be enrolled after informed consent. Randomization will be undertaken once post PCI echocardiography is done and LV function is recorded. Patients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT for two weeks in addition to other guideline directed medical therapy (GDMT). After two weeks of triple therapy (DOAC+DAPT), aspirin will be dropped in the study arm. The control arm will be of standard care. After 4 weeks, treatment group will be switched to DAPT.
Follow up The primary endpoint will be the incidence of LV thrombus formation recorded at 4-week follow-up echocardiography. Patients' clinical status, side effects, and medication compliance will be recorded.
At 2-week: patients will be contacted via phone call to assess their clinical status, ensure drug compliance, discuss any necessary changes in drug regimen for those in the treatment group already prescribed on discharge, and inquire about any side effects.
At 4-week: patients will undergo an in-person follow-up where echocardiography will be conducted alongside a comprehensive assessment In case of any cardiac complaints, patients will be advised to visit the hospital or cardiologist promptly to complete a comprehensive clinical and laboratory workup. Primary endpoint
. Incidence of LV thrombus formation in the treatment arm vs. placebo at 4 week follow up echocardiography.
Secondary endpoints
* composite of death, recurrent myocardial infarction, stent thrombosis, and heart failure hospitalization in experimental arm vs. control group.
* Major and minor bleeding in experimental arm vs. control group
* Discontinuation of the drug due to side effects in experimental arm vs. control group A clinical events committee whose members are unaware of study-group assignments will independently adjudicate all potential endpoints.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
Primary endpoint will be the incidence of left ventricular thrombus in the study arm vs the control group at one month echocardiographic follow up. While an open label trial, end point adjudication will be blinded where the echocardiographer will not know treatment allocation of the two groups.
PREVENTION
SINGLE
Study Groups
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Study arm (Apixaban 2.5 mg bid)
Patients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT (aspirin (75 mg) + clopidogrel (75 mg)) for four weeks in addition to other guideline directed medical therapy (GDMT). After 4 weeks, treatment group will be switched to DAPT. o In the event of stent thrombosis during the study period, considering the high ischemic risk, the patient will be switched to ticagrelor instead of clopidogrel, and aspirin will be discontinued while Apixaban will be continued. After four weeks, the patient will be switched to DAPT (aspirin
\+ ticagrelor).
Apixaban 2.5 MG PO BID
Patients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT (aspirin (75 mg) + clopidogrel (75 mg)) for four weeks in addition to other guideline directed medical therapy (GDMT). After 4 weeks, treatment group will be switched to DAPT.
Control group
The control arm will be of standard care i.e. DAPT in addition to other guideline directed medical therapy (GDMT).
Control (Standard treatment)
DAPT plus guideline directed medical therapy
Interventions
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Apixaban 2.5 MG PO BID
Patients randomized to the treatment arm will be given Apixaban 2.5 mg twice daily and DAPT (aspirin (75 mg) + clopidogrel (75 mg)) for four weeks in addition to other guideline directed medical therapy (GDMT). After 4 weeks, treatment group will be switched to DAPT.
Control (Standard treatment)
DAPT plus guideline directed medical therapy
Eligibility Criteria
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Inclusion Criteria
* Presenting with acute anterior STEMI
* Severe LV dysfunction (EF\<35%) with antero-apical akinesis, dyskinesis, or aneurysm
* WIHTOUT evidence of LV thrombus.
Exclusion Criteria
* Patients with cardiogenic shock
* Patients with LV thrombus
* Patients with advanced CKD (Cr \> 2 and those on hemodialysis)
* Recent ICH or major bleed requiring transfusion, low platelet counts \<100,000
* History of recent CVA ( within past three months)
* Patients with atrial fibrillation or other indications for chronic anticoagulation
* Pregnant patients and those with hematological disorders
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Cardiovascular Diseases, Pakistan
OTHER
Responsible Party
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Professor Abdul Hakeem
professor
Principal Investigators
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Abdul Hakeem Professor of Cardiology, Director Cardiac Catheterization Labs, MD FACC FSCAI FASE
Role: PRINCIPAL_INVESTIGATOR
NICVD
Locations
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NICVD Pakistan
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Abdul Hakeem, MD
Role: primary
References
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Zhang Z, Si D, Zhang Q, Jin L, Zheng H, Qu M, Yu M, Jiang Z, Li D, Li S, Yang P, He Y, Zhang W. Prophylactic Rivaroxaban Therapy for Left Ventricular Thrombus After Anterior ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Interv. 2022 Apr 25;15(8):861-872. doi: 10.1016/j.jcin.2022.01.285. Epub 2022 Mar 30.
Camaj A, Fuster V, Giustino G, Bienstock SW, Sternheim D, Mehran R, Dangas GD, Kini A, Sharma SK, Halperin J, Dweck MR, Goldman ME. Left Ventricular Thrombus Following Acute Myocardial Infarction: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Mar 15;79(10):1010-1022. doi: 10.1016/j.jacc.2022.01.011.
Bulluck H, Chan MHH, Paradies V, Yellon RL, Ho HH, Chan MY, Chin CWL, Tan JW, Hausenloy DJ. Incidence and predictors of left ventricular thrombus by cardiovascular magnetic resonance in acute ST-segment elevation myocardial infarction treated by primary percutaneous coronary intervention: a meta-analysis. J Cardiovasc Magn Reson. 2018 Nov 8;20(1):72. doi: 10.1186/s12968-018-0494-3.
Other Identifiers
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IRB-83/2024
Identifier Type: -
Identifier Source: org_study_id