Status:
UNKNOWN
Ticagrelor Versus Clopidogrel in Left Ventricular Remodeling After ST-segment Elevation Myocardial Infarction
Lead Sponsor:
Gyeongsang National University Hospital
Collaborating Sponsors:
Chinese PLA General Hospital
Chungnam National University Hospital
Conditions:
ST Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Detailed 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) ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT02224534
Start Date
October 1 2014
End Date
December 1 2017
Last Update
November 15 2016
Active Locations (12)
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1
Chinese PLA General Hospital
Beijing, China
2
National University Heart Centre
Singapore, Singapore
3
Chonnam National University Hospital
Gwangju, CHONRANAM-Do, South Korea
4
Seoul National University Bundang Hospital
Bundang, Gyeongki-do, South Korea