Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction

NCT06742567 | Recruiting Phase 3 DMC

• 1 other identifier: IRB-83/2024
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized controlled trial is to compare the safety and efficacy of low dose Apixaban (2.5 mg bid) in addition to guideline directed medical therapy vs guideline directed medical therapy alone in the prevention of left ventricular thrombus formation (after 30-days) following primary PCI in patients with acute anterior myocardial infarction with severe LV dysfunction.

Conditions

Acute Myocardial Infarction of Anterior Wall; Left Ventricular Thrombus; Prophylaxis

Keywords

Acute myocardial infarction; severe left ventricular dysfunction; prevention of LV thrombus; DOAC; apixaban

Outcome Measures

Primary Outcomes (1)

• Incidence of LV thrombus formation in the treatment arm vs. control group

  Incidence of LV thrombus formation in the treatment arm vs. control group at 4 week follow up echocardiography. This constitutes the primary endpoint of the trial

  one month

Secondary Outcomes (1)

• Secondary Outcomes

  one month

Study Arms (2)

Study arm (Apixaban 2.5 mg bid)

EXPERIMENTAL

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).

Drug: Apixaban 2.5 MG PO BID

Control group

ACTIVE COMPARATOR

The control arm will be of standard care i.e. DAPT in addition to other guideline directed medical therapy (GDMT).

Drug: Control (Standard treatment)

Interventions

Apixaban 2.5 MG PO BID DRUG

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.

Study arm (Apixaban 2.5 mg bid)

Control (Standard treatment) DRUG

DAPT plus guideline directed medical therapy

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• Presenting with acute anterior STEMI
• Severe LV dysfunction (EF\<35%) with antero-apical akinesis, dyskinesis, or aneurysm
• WIHTOUT evidence of LV thrombus.

You may not qualify if:

• Patients with previous anterior myocardial infarction or LAD revascularization procedures
• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

NICVD Pakistan

Karachi, Sindh, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 35367170 BACKGROUND

• 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.

  PMID: 35272796 BACKGROUND

• 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.

  PMID: 30404623 BACKGROUND

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction; Ventricular Dysfunction, Left

Interventions

apixaban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Ventricular Dysfunction

Study Officials

• Abdul Hakeem Professor of Cardiology, Director Cardiac Catheterization Labs, MD FACC FSCAI FASE

  NICVD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdul Hakeem, MD FACC FSCAI FASE

CONTACT

+92 3355554342; ahakeem@gmail.com

Sabha Bhatti, MD FASE FASNC FACC

CONTACT

608-772-3048; drsabhabhatti@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Eligible patients will be enrolled after informed consent. Randomization will be undertaken once post primary PCI echocardiography is done and LV function is recorded. Patients with anterior wall myocardial infarction with severe left ventricular dysfunction defined by an EF\<35% without evidence of LV thrombus will be screened. 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 standard DAPT and GDMT without apixiban. 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.

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 19, 2024
• Study Start: December 2, 2024
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

PA (1)