Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction (HEALING-AMI)

Gyeongsang National University Hospital

Status and phase: Unknown; Phase 4

Conditions: ST Elevation Myocardial Infarction

Treatments: Drug: Ticagrelor; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT02224534

D5130C00138

Details and patient eligibility

About

The purpose of the study is to evaluate the novel role of ticagrelor to improve long-term LV remodeling following ST-segment elevation myocardial infarction.

Full description

The investigators designed the HEALING-AMI study to compare the influence of ticagrelor (180 mg loading and 90 mg twice daily maintenance) vs. clopidogrel (600 mg loading and 75 mg daily maintenance) on long-term left ventricular (LV) remodeling measured by 3D echocardiography in STEMI patients undergoing primary PCI.

The primary objective of the HEALING-AMI study is to demonstrate the novel role of long-term ticagrelor therapy in reducing the risk of LV remodeling,. The secondary objectives are to reveal the cross-talk between platelet and inflammatory process in ST-segment elevation myocardial infarction (STEMI) patients. Moreover, this study will determine whether the high platelet inhibition by ticagrelor culminate the protection of infarcted myocardium.

Enrollment: 326 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years and older.
• First-time onset STEMI patients uneventfully treated with primary PCI within 12 hours of onset of symptom.
• Infarct-related artery with TIMI 0, 1, or 2 grade flow at the time of initial diagnostic angiography (before wire passage).
• proximal or mid-portion lesion of epicardial coronary artery.

Exclusion criteria

• Previous history of myocardial infarction.
• Left bundle branch block on ECG at the time of screening.
• Cardiogenic shock at the time of randomization.
• Refractory ventricular arrhythmias or atrial fibrillation.
• New York Heart Association class IV congestive heart failure.
• Severe or malignant hypertension (SBP> 180 and/or DBP> 120 mmHg).
• Fibrinolytic therapy.
• History of hemorrhagic stroke.
• Intracranial neoplasm, arteriovenous malformation, or aneurysm.
• Ischemic stroke within 3 months prior to screening.
• Platelet count < 100,000/mm3 or hemoglobin < 10 g/dL.
• A need for oral anticoagulation therapy that cannot be safely discontinued for the duration of the study.
• Women who are known to be pregnant, have given birth within the past 90 days, or are breast-feeding.
• Unable to cooperate with protocol requirements and follow-up procedures.
• A history of P2Y12 receptor inhibitor pretreatment (at least prior 1 month).
• An increased risk of bradycardia.
• Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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326 participants in 2 patient groups

Ticagrelor and Clopidogrel.

Experimental group

Description:

The patients assigned to the TICA group have loading dose of ticagrelor 180 mg just after the randomization, and then ticagrelor 90 mg twice daily during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.

Treatment:

Drug: Ticagrelor

Clopidogrel

Active Comparator group

Description:

The patients assigned to the CLPD group have loading dose of clopidogrel 600 mg just after the randomization, and then clopidogrel 75 mg daily should be maintained during the study period. All patients also have aspirin 300 mg as a loading dose and 100 mg once daily as a maintenance dose.

Treatment:

Drug: Clopidogrel