TACTIC Coronary Thrombus Aspiration With Cath Rx In Anterior Myocardial Infarction: A Randomized Control Trial.

Launched by CERIC SÀRL · Mar 19, 2025

Keywords

ClinConnect Summary

The TACTIC trial is a research study designed to see if a special procedure called thrombectomy, which helps remove blood clots, can improve recovery for patients experiencing a heart attack in the front part of the heart (called an anterior myocardial infarction). Specifically, the study will compare the effects of using a device called the INDIGO ASPIRATION SYSTEM during a procedure known as primary percutaneous coronary intervention (PPCI) against standard treatment without this device. Researchers will look at heart health indicators, like the size of the heart damage, using advanced imaging techniques a few days after the procedure.

To participate in this trial, individuals must be between 18 and 75 years old and have been diagnosed with a specific type of heart attack that meets certain criteria, such as having significant changes on an ECG (a test that measures heart activity) and experiencing symptoms for 1 to 6 hours before arriving at the hospital. It’s important to note that some people may not be eligible, including those with severe health issues or conditions that could complicate the procedure. Participants in the study will receive careful monitoring and support throughout their treatment process, helping researchers gather valuable information that could improve heart attack care in the future.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• • 1. Age \>18 and \<75 years old
• • 2. Acute anterior STEMI with ≥2 mm in two (2) or more contiguous anterior leads or ≥4 mm total ST-segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
• • 3. Culprit lesion proximal or mid LAD at coronary angiography
• • 4. TIMI thrombus grading \> 3 or TIMI flow 0 after guidewire crossing the lesion.
• • 5. Patient presents to the hospital between 1 - 6 hours of ischemic pain onset
• • 6. Patient indicated for primary percutaneous coronary intervention (PPCI)
• • EXCLUSION CRITERIA
• • 1. Unable to give Informed consent.
• • 2. Life expectancy \< 1 year.
• • 3. Contraindication to PCI
• • 4. STEMI due to stent thrombosis
• • 5. Spontaneous coronary aretery dissection
• • 6. Patient undergone any kind of maneuvers to restore flow before randomization
• • 7. Unwitnessed cardiac arrest OR ≥30 minutes of cardiopulmonary resuscitation (CPR) prior to enrolment OR any cardiac arrest with impairment in mental status, cognition or any global or focal neurological deficit
• • 8. New onset of stroke symptoms and NIHSS \>2, prior to index procedure
• • 9. Known intolerance to aspirin, clopidogrel, ticagrelor, heparin, contrast media.
• • 10. Active severe bleeding
• • 11. Severe hepatic/kidney impairment
• • 12. Administration of fibrinolytic therapy within 24 hours prior to enrolment
• • 13. Cardiogenic shock defined as systemic hypotension (systolic BP \<90 mmHg or the need for inotropes/pressors to maintain a systolic BP \>90 mmHg), plus one (1) of the following: any requirement for pressors / inotropes prior to arrival at the catheterization laboratory, clinical evidence of end-organ hypoperfusion, or use of IABP or any other mechanical circulatory support device
• • 14. Inferior STEMI or suspected right ventricular failure
• • 15. Severe valvulopathy
• • 16. Acute cardiac mechanical complication: LV-free wall rupture OR interventricular septum rupture OR acute mitral regurgitation
• Medical Conditions \& History:
• • 1. Suspected or known pregnancy
• • 2. Suspected systemic active infection
• • 3. History or known hepatic insufficiency prior to catheterization
• • 4. Undergoing a renal replacement therapy
• • 5. Chronic obstructive pulmonary disease (COPD) with home oxygen therapy or on chronic steroid therapy
• • 6. Contraindication to perform MRI or use gadolinium \[creatinine clearance (CrCl) \<30 mL/min, non-compatible implant, claustrophobia\]
• • Cardiovascular history
• • 1. Known or evidence of prior MI, including pathologic Q-waves in non-anterior leads
• • 2. Prior coronary artery bypass graft surgery (CABG) or LAD PCI
• • 3. History of heart failure (documented history of EF \<40% or documented hospitalization for HF within 1 year prior to screening
• • 4. Prior aortic valve surgery or TAVR
• • 5. Left bundle branch block (new or old)
• • 6. History of stroke/TIA within 3 months prior to screening